http://repub.eur.nl/res/aut/1050/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/25279/ 2009-06-01T00:00:00Z Background-The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation. Methods and Results-We conducted a randomized (2:1), controlled trial comparing the Biolimus A9- eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11±0.30 mm versus 0.32±0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P=0.001) and the secondary hypothesis of superiority (P<0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5±7.2% in Taxus to 1.8±5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm. Conclusions-The NOBORI 1 clinical trial confirmed its primary hypothesis-noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population. http://repub.eur.nl/res/pub/4797/ 2002-02-20T00:00:00Z OBJECTIVES: We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial. BACKGROUND: There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome. METHODS: After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. RESULTS: Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%). CONCLUSIONS: Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery. http://repub.eur.nl/res/pub/4798/ 2002-02-06T00:00:00Z OBJECTIVES: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm). BACKGROUND: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length. METHODS: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms. RESULTS: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups. CONCLUSIONS: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months. http://repub.eur.nl/res/pub/4821/ 2001-09-12T00:00:00Z Aims To prospectively evaluate the influence of stent length on 6 month clinical and angiographic outcome, in patients with native coronary lesions up to 45mm in length, undergoing elective Magic Wallstent implantation. Methods and Results On the basis of pre-procedural angiography, 276 patients (aged 61·3±10·2 years; 78·6% male; 41·7% unstable angina) with a total of 302 lesions were prospectively assigned to one of five different length categories of Magic Wallstent. Angiography in multiple matched projections before and after implantation and at 6 months follow-up was analysed at the core laboratory. Primary end-points for the efficacy analysis were cumulative incidence of major adverse cardiac events and quantitative coronary angiography analysis 6 months after stent implantation. Magic Wallstent implantation was successful in 301 of 302 lesions and in 98·6% a residual stenosis <20% by online quantitative coronary angiography was achieved. At 30 days, 6·2% (1·8% subacute occlusion) of patients had experienced major adverse cardiac events, 27·5% at 6 months and 30·4% at 9 months. Angiographic restenosis occurred in 37%. Restenosis rates for the mini, extra-short, short, medium and long Wallstent groups were 25·9%, 25%, 22·6%, 36·2% and 67·5%, respectively. Multivariate analysis revealed stent length to be independently associated with greater angiographic restenosis and major adverse cardiac events. Conclusions While shorter Magic Wallstents provided late outcomes comparable with short balloon-expandable stents, excessive restenosis with longer Wallstents should obviate their use in elective percutaneous intervention. Long coronary lesions provide a challenging substrate for emerging antirestenosis therapies, such as stent coatings and brachytherapy. http://repub.eur.nl/res/pub/8332/ 2001-01-01T00:00:00Z OBJECTIVE: Lefradafiban is the orally active prodrug of fradafiban, a glycoprotein IIb/IIIa receptor antagonist. The present phase II study aimed to determine the dose of lefradafiban that provides 80% blockade of the glycoprotein IIb/IIIa receptors by fradafiban, and to study the pharmacodynamics and safety of different doses in patients with stable angina undergoing angioplasty. DESIGN: A double blind, placebo controlled, dose finding study. SETTING: Four academic and community hospitals in the Netherlands. PATIENTS: 64 patients with stable coronary artery disease undergoing elective percutaneous transluminal coronary angioplasty. INTERVENTIONS: 30 mg, 45 mg, and 60 mg of lefradafiban three times daily or placebo was given for 48 hours. MAIN OUTCOME MEASURES: The primary safety end point was the occurrence of bleeding, classified as major, minor, or insignificant according to the thrombolysis in myocardial infarction (TIMI) criteria. Efficacy indices included per cent fibrinogen receptor occupancy (FRO), ex vivo platelet aggregation, and plasma concentrations of fradafiban. RESULTS: Administration of lefradafiban 30, 45, and 60 mg three times daily resulted in a dose dependent increase in median FRO levels of 71%, 85%, and 88%, respectively. Inhibition of platelet aggregation was closely related to FRO. There were no major bleeding events. The 60 mg lefradafiban group had a high (71%) incidence of minor and insignificant bleeding. The incidence of bleeding was 44% in the 30 mg and 45 mg groups, compared with 9% in placebo patients. Puncture site bleeding was the most common event. The odds of bleeding increased by 3% for every 1% increase in FRO. CONCLUSIONS: Lefradafiban is an effective oral glycoprotein IIb/IIIa receptor blocker. The clinical effectiveness of doses up to 45 mg three times daily should be investigated. http://repub.eur.nl/res/pub/4911/ 1999-01-01T00:00:00Z OBJECTIVES This study was performed to assess whether angiography six months after coronary balloon angioplasty or stent implantation has an influence on clinical management and one-year outcome. BACKGROUND The Benestent II study randomized 827 patients to balloon angioplasty or stent implantation. A subrandomization was undertaken allocating patients to six-month clinical follow-up (CF) or clinical and angiographic follow-up (AF). METHODS Seven hundred and six patients (349 CF and 357 AF) had no intercurrent angiography, so that restenosis and disease progression elsewhere remained unknown until the time of six-month follow-up. These two groups, which were well matched at enrolment, were compared with respect to symptoms, medication and major cardiac events defined as death, myocardial infarction and need for revascularization at six and 12 months. RESULTS At six-month follow-up, 53 (15%) of the CF and 76 (21%) of the AF patients had stable angina (p 5 0.041), while 5 (1%) and 4 (1%) had symptoms of unstable angina. At 12-month follow-up, 44 (13%) patients in both groups had stable angina, and only 1 patient in the CF group had unstable angina. Seventy-seven patients (27 CF and 50 AF; p , 0.01) had major cardiac events between 6 and 12 months. Of the 349 patients in the CF group, 21 underwent repeat percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery between 6 and 12 months, compared with 44 of the 357 patients in the AF group (relative risk 2.05 [1.24 to 3.37], p 5 0.003). CONCLUSIONS Patients who had AF six months after balloon angioplasty or stent implantation experienced more repeat revascularization procedures than those who had CF. They also had significantly more angina at six-month follow-up but this may be due to bias http://repub.eur.nl/res/pub/9059/ 1999-01-01T00:00:00Z BACKGROUND: The 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors competitively inhibit biosynthesis of mevalonate, a precursor of non-sterol compounds involved in cell proliferation. Experimental evidence suggests that fluvastatin may, independent of any lipid lowering action, exert a greater direct inhibitory effect on proliferating vascular myocytes than other statins. The FLARE (Fluvastatin Angioplasty Restenosis) Trial was conceived to evaluate the ability of fluvastatin 40 mg twice daily to reduce restenosis after successful coronary balloon angioplasty (PTCA). METHODS: Patients were randomized to either placebo or fluvastatin 40 mg twice daily beginning 2-4 weeks prior to planned PTCA and continuing after a successful PTCA (without the use of a stent), to follow-up angiography at 26+/-2 weeks. Clinical follow-up was completed at 40 weeks. The primary end-point was angiographic restenosis, measured by quantitative coronary angiography at a core laboratory, as the loss in minimal luminal diameter during follow-up. Clinical end-points were death, myocardial infarction, coronary artery bypass graft surgery or re-intervention, up to 40 weeks after PTCA. RESULTS: Of 1054 patients randomized, 526 were allocated to fluvastatin and 528 to placebo. Among these, 409 in the fluvastatin group and 427 in the placebo group were included in the intention-to-treat analysis, having undergone a successful PTCA after a minimum of 2 weeks of pre-treatment. At the time of PTCA, fluvastatin had reduced LDL cholesterol by 37% and this was maintained at 33% at 26 weeks. There was no difference in the primary end-point between the treatment groups (fluvastatin 0.23+/-0.49 mm vs placebo 0.23+/-0.52 mm, P=0.95) or in the angiographic restenosis rate (fluvastatin 28%, placebo 31%, chi-square P=0.42), or in the incidence of the composite clinical end-point at 40 weeks (22.4% vs 23.3%; logrank P=0.74). However, a significantly lower incidence of total death and myocardial infarction was observed in six patients (1.4%) in the fluvastatin group and 17 (4.0%) in the placebo group (log rank P=0.025). CONCLUSION: Treatment with fluvastatin 80 mg daily did not affect the process of restenosis and is therefore not indicated for this purpose. However, the observed reduction in mortality and myocardial infarction 40 weeks after PTCA in the fluvastatin treated group has not been previously reported with statin therapy. Accordingly, a priori investigation of this finding is indicated and a new clinical trial with this intention is already underway. http://repub.eur.nl/res/pub/5056/ 1996-12-01T00:00:00Z Background. Thrombin is a key enzyme in thrombogenesis. In animals, specific antithrombotic therapy at the time of coronary angioplasty reduced the incidence of subacute occlusion and inhibited the restenosis response. Argatroban is a highly selective synthetic thrombin antagonist that binds in a competitive manner. This is a report of a dose-verification study, assessing the safety and feasibility of intravenous Argatroban administration in patients undergoing percutaneous transluminal coronary angioplasty. Methods. Before angioplasty an intravenous bolus of 30 g/kg argatroban was administered, followed by a continuous infusion of 3.5 g/kg/min for 72 hours. Bolus injection was repeated, and the infusion rate was increased in order to achieve an activated coagulation time (ACT) of over 300 seconds. Following interim analysis, the bolus and initial infusion rate for the subsequent treatment groups was determined. Study endpoints were the occurrence of adverse events, coagulation tests, and qualitative angiogram reading. Patients were monitored by continuous 12-lead electrocardiographic recording over 24 hours, and underwent control angiography 18–24 hours following angioplasty. Results. Four treatment groups, comprised of 2, 8, 9, and 11 patients, respectively, were studied. The first two patients were excluded from analysis, since the initial dose was ineffective to attain an ACT-authorizing coronary angioplasty. The group with the highest dosage received a 250 g/kg intravenous bolus of argatroban, followed by a 4 hour infusion of 15 g/kg/min. At 4 hours the infusion rate was lowered to 3.8 g/kg/min and was continued for 68 hours without adjustment for catheter removal. The adverse event profile included myocardial infarction, aortocoronary bypass graft, bailout procedures, and repeat coronary angioplasty. Thrombin-time (TT), activated partial thromboplastin time (APTT), and prothrombin time (PT) were significantly related to argatroban plasma concentration, as demonstrated by regression analyses (R-square 0.64, 0.71, and 0.84, respectively). Prothrombin fragments 1 and 2 and thrombin-antithrombin III complex did not fit into a mathematical model, but showed slightly increased levels after reduction or cessation of the infusion rate. Conclusions. This dose-verification study, including 30 patients at four dose levels, indicated that argatroban infusion in coronary angioplasty patients can be administered safely, and results in an adequate and predictable level of anticoagulation. http://repub.eur.nl/res/pub/5048/ 1996-02-01T00:00:00Z Objectives. This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. Background. The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. Methods. To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. Results. After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. Conclusions. These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention. http://repub.eur.nl/res/pub/5047/ 1996-01-01T00:00:00Z Background The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. Methods and Results The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04]). Conclusions The implantation of stents coated with polyamine and end-point–attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months. http://repub.eur.nl/res/pub/5523/ 1996-01-01T00:00:00Z The comparative efficacy of thrombolytic drugs and primary angioplasty for acute myocardial infarction have recently been studied, but long-term follow-up data have not yet been reported. We conducted a randomized trial involving 301 patients with acute myocardial infarction; 152 patients were randomized to primary angioplasty and 149 to intravenous streptokinase. Left ventricular function was assessed with a radionuclide technique both at hospital discharge and at the end of the follow-up period. Follow-up data were collected after a mean (+/-SD) of 31 +/- 9 months. Total medical costs were calculated. At the end of the follow-up period, 5% of the angioplasty patients had died from a cardiac cause compared to 11% of the patients randomized to intravenous streptokinase, P = 0.031. Cardiac death or a non-fatal reinfarction occurred in 7% of angioplasty patients compared to 28% of streptokinase patients, P < 0.001. There was a sustained benefit of angioplasty compared to streptokinase on left ventricular function. The total medical costs in the two groups were similar. Coronary anatomy (patency and single or multivessel disease), infarct location and previous myocardial infarction were important determinants of clinical outcome and costs. After 31 +/- 9 months of follow-up, primary angioplasty compared to intravenous streptokinase results in a lower rate of cardiac death and reinfarction, a better left ventricular ejection fraction, and no increase in total medical costs. http://repub.eur.nl/res/pub/4540/ 1993-01-01T00:00:00Z BACKGROUND. Enhanced thrombin activity has been associated with acute and long-term complications following balloon angioplasty (percutaneous transluminal coronary angioplasty (PTCA). We evaluated, in a 2-to-1 randomized, double-blind trial, the effects of recombinant hirudin, CGP 39 393, relative to unfractionated sodium heparin on periprocedural events, bleeding, early angiographic outcome, and coagulation in 113 patients with stable angina undergoing PTCA. METHODS AND RESULTS. Prior to PTCA, 20 mg CGP 39 393 was administered as a bolus, followed by continuous infusion at a rate of 0.16 mg.kg-1 x h-1, or 10,000 IU sodium heparin was administered as a bolus and continued at a rate of 12 IU.kg-1 x h-1 for 24 hours. Infusion was adjusted to activated partial thromboplastin time (APTT) levels. ST segment was monitored for 24 hours, and angiograms were analyzed with quantitative technique (QCA). In 74 CGP 39 393- and 39 heparin-treated patients, 132 lesions were dilated. Myocardial infarction and/or emergency coronary bypass surgery occurred in 1 (1.4%) CGP 39 393 patient compared with 4 (10.3%) heparin patients (relative risk, 7.6; 95% confidence interval, 0.9, 65.6). At 24 hours, complete perfusion was present in 91% heparin and 100% CGP 39 393 patients. Significant ST segment displacement was found in 11% of heparin versus 4% of CGP 39 393 subjects. Bleeding occurred only at the puncture site in 4 CGP 39 393-treated patients. QCA did not reveal significant differences between the groups. APTT values were more often in the target range and more stable in CGP 39 393 patients. Levels of thrombin-antithrombin III complexes, prothrombin fragment F1+2, and fibrinopeptide A indicated that CGP 39 393 was an effective inhibitor of thrombin activity. CONCLUSIONS. CGP 39 393 can safely be administered to patients undergoing elective PTCA for stable anginal symptoms and may have a more favorable anticoagulant profile than heparin. http://repub.eur.nl/res/pub/4545/ 1993-01-01T00:00:00Z Because of the unavoidable occurrence of vessel disruption after successful coronary balloon angioplasty, the reliability of quantitative angiographic analysis in that setting has been questioned. For this reason and the suggested occurrence of delayed elastic recoil, repeat angiography at 24 hours has been advocated in clinical interventional trials. In this study, these issues are confronted by performing comprehensive quantitative analysis (Cardiovascular Angiographic Analysis System) of coronary angiograms, acquired in multiple identical projections immediately after and 24 hours after angioplasty, in 102 patients with 110 successfully dilated lesions. Vasomotion was controlled by intracoronary nitrate before angiography and all patients were fully anticoagulated (activated partial thromboplastin time 85 to 120 seconds) for > 24 hours. Paired Student's t tests applied to angiographic measurements revealed that there was no significant deterioration in minimal luminal diameter or cross-sectional area from immediately after angioplasty to 24 hours later. It can thus be inferred that there is no phenomenon of delayed elastic recoil, at least during this time period. Measurement accuracy and precision of the Cardiovascular Angiographic Analysis System from the postangioplasty angiogram are highly acceptable, at < 0.01 and +/- 0.20 mm, respectively. Therefore, it is concluded that routine repeat 24-hour angiography is not indicated after successful angioplasty. A highly significant increase (p < 0.001) in reference diameter (+0.11 +/- 0.18 mm) was responsible for the apparent increase in percent diameter stenosis (2.4 +/- 7%), a finding that demonstrates the potential for error by selective application of percent diameter stenosis measurements alone. Preferential use of absolute luminal measurements is thus strongly recommended for clinical trials with angiographic monitoring. http://repub.eur.nl/res/pub/4444/ 1992-01-01T00:00:00Z OBJECTIVE: To study the immediate and long term clinical success of percutaneous transluminal coronary balloon angioplasty in patients over 70 years old. DESIGN--Patients undergoing percutaneous transluminal angioplasty were prospectively entered in a specially designed database. The clinical and angiographic data of all patients over 70 were reviewed. Follow up data were collected by interview, during outpatient visits, by questionnaire, or through the referring physician. SETTING--A tertiary referral cardiac centre. PATIENTS--166 patients over 70 (median 73, range 70-84) underwent coronary angioplasty because of unstable angina (81 patients), stable angina (76 patients), or acute myocardial infarction (nine patients). RESULTS--The initial clinical success rate was 86% (142 of 166 patients). A major procedural complication occurred in 10 patients (6%): four patients (2%) died, six patients (4%) underwent emergency bypass surgery, and five patients (3%) sustained an acute myocardial infarction. In 14 patients (8%) coronary angioplasty did not significantly reduce the diameter stenosis but there were no associated complications. A total of 226 lesions were attempted. The initial angiographic success rate was 192 out of 226 lesions (85%). The median follow up was 21 (range 0.5-66) months. Sixteen patients (10%) died during follow up, eight patients (5%) sustained a non-fatal myocardial infarction, 21 patients (13%) underwent a second or third balloon dilatation, and 17 patients (10%) underwent elective bypass surgery. Of the 146 survivors, 99 patients (68%) had sustained clinical improvement. The estimated survival at four years (Kaplan-Meier method) was 89 (SD 4)%. The event free survival at four years for the total study population was 61 (8)%. Multivariate logistic regression analysis showed that the extent of vessel disease was the only independent predictive factor for event free survival: the event free survival rate was 81 (10)% at four years for patients with single vessel disease, compared with 45 (12)% for patients with multivessel disease. CONCLUSIONS--Coronary angioplasty in patients over 70 was a safe and effective treatment for obstructive coronary artery disease. The extent of vessel disease, and not the completeness of revascularisation, was the only independent predictive factor for event free survival. http://repub.eur.nl/res/pub/4445/ 1992-01-01T00:00:00Z Restenosis after coronary angioplasty is the single complication that most limits this revascularization procedure in clinical practice. The process is largely unpredictable and the lesion-related factors predisposing to restenosis are poorly understood, with little consensus in published reports. In this study using detailed quantitative angiographic measurements to assess 490 lesions, the simple lesion characteristics associated with restenosis were defined and the relation to the restenosis process documented. Restenosis was defined as an absolute deterioration in the minimal lumen diameter by greater than or equal to 0.72 mm, a criterion based on the 95% confidence intervals for repeat angiographic measurements. This was chosen in an attempt to separate spurious changes due to a poor angiographic result and the variability of angiographic measurements from significant changes due to the restenosis process. The principal determinants of restenosis were found to be a large improvement in the minimal lumen diameter at the time of dilation (1.13 mm for the restenosis group compared with 0.86 mm for the no restenosis group [p less than 0.0001]) and an optimal postangioplasty result (minimal lumen diameter 2.28 mm in the restenosis group compared with 2.05 mm [p less than 0.001] in the no restenosis group, corresponding to a 25% and a 30% diameter stenosis, respectively [p less than 0.0001]). These observations reported for the first time suggest that the distinction needs to be made between a "clinical restenosis" of greater than or equal to 50% diameter stenosis and the "restenosis process" as measured by the absolute changes occurring during and after angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS) http://repub.eur.nl/res/pub/4462/ 1992-01-01T00:00:00Z The effects of intravenous elgodipine, a new second-generation dihydropyridine calcium antagonist, on hemodynamics and coronary artery diameter were investigated in 15 patients undergoing cardiac catheterization for suspected coronary artery disease. Despite a significant decrease in systemic blood pressure, elgodipine infused at a rate of 1.5 micrograms/kg/min over a period of 10 minutes did not affect heart rate and left ventricular end-diastolic pressure. The contractile responses during isovolumic contraction showed a slight but significant increase in maximum velocity (56 +/- 10 to 60 +/- 10 seconds-1; p less than 0.005), whereas the time constant of early relaxation was shortened from 49 +/- 11 to 44 +/- 9 ms (p less than 0.05). Coronary sinus and great cardiac vein flow increased significantly by 15 and 26%, respectively. As mean aortic pressure decreased, a significant decrease in coronary sinus (-27%) and great cardiac vein (-28%) resistance was observed, while the calculated myocardial oxygen consumption remained unchanged. In all, 69 coronary segments (including 13 stenotic segments) were analyzed quantitatively using computer-assisted quantitative coronary angiography. A significant increase in mean coronary artery diameter (2.27 +/- 0.53 to 2.48 +/- 0.53 mm; p less than 0.000001), as well as in obstruction diameter, (1.08 +/- 0.29 to 1.36 +/- 0.32 mm; p less than 0.02), was observed. The results demonstrate that elgodipine, in the route and dose described, induces significant vasodilatation of both coronary resistance and epicardial conductance vessels, without adverse effects on heart rate, myocardial oxygen demand and contractile indexes. http://repub.eur.nl/res/pub/4464/ 1992-01-01T00:00:00Z OBJECTIVE--To investigate whether balloon dilatation of the aortic valve induces long-term macroscopic or histological changes or both to explain the restenosis process. DESIGN--Prospective study of 39 consecutive patients. Sixteen later (mean (SD) 12 (10) months) required operation. This non-randomised subgroup was compared with 10 patients who had aortic valve replacement without prior dilatation. SETTING--University cardiology and cardiac surgery centre and pathology department. PATIENTS--16 patients who had aortic valve replacement because of failure of or restenosis after balloon dilatation of the aortic valve. Twelve resected valves were examined. INTERVENTIONS--Percutaneous balloon dilatation of the aortic valve (maximal balloon size: trefoil 3 x 12 mm balloon or bifoil 2 x 19 mm balloon) and surgical inspection before excision of the aortic valve leaflets during open-chest aortic valve replacement. Fixation, decalcification, and staining for histology. MAIN OUTCOME MEASURES--Presence of long-term pathological changes in the resected valve and their relation to restenosis after balloon dilatation. RESULTS--Macroscopically the previously dilated valves were indistinguishable from valves from the patients who had valve replacement only. Microscopically, the dilated aortic valves showed areas of young scar tissue that were not seen in a control group of surgically excised stenotic aortic valves. This persistent scarring reaction was seen around small tears or lacerations of the collagenous valve stroma, fractures in calcified areas, and splits in commissures. Young scar tissue without collagenisation was still present 24 months after dilatation. CONCLUSION--Organisation and collagenisation of scar tissue develops slowly after balloon dilatation of the aortic valve. This prolonged scarring reaction may explain the late development of restenosis in some patients. http://repub.eur.nl/res/pub/4412/ 1991-01-01T00:00:00Z BACKGROUND. Acute coronary artery occlusion after percutaneous transluminal coronary angioplasty (PTCA) continues to remain a serious complication despite significant improvement in operator performance and technological advancements. This retrospective study was performed to ascertain the frequency, predictive variables, management, and outcome of acute coronary artery occlusion. METHODS AND RESULTS. The study was based on data from 1,423 consecutive patients who underwent an elective coronary angioplasty between January 1986 and December 1988. Acute coronary artery occlusion occurred in 104 patients (7.3%). Acute occlusion developed during the dilatation procedure in 80 patients (5.6%) and within 24 hours after the procedure in 24 patients (1.7%). Four clinical and 14 angiographic variables predictive for acute coronary artery occlusion were analyzed in these 104 patients with a complicated procedure and were compared with those in 104 representative patients with successful attempts. Multivariate analysis found three independent predictive variables: unstable angina, multivessel disease, and complex lesions. The overall clinical outcome after management of acute coronary artery occlusion including immediate repeat dilatation (95 patients), use of intracoronary streptokinase (34 patients), or autoperfusion catheter (12 patients) was successful (reduction of lumen diameter to less than 50%, no death, no myocardial infarction [MI], and no emergency surgery) in 42 patients (40%), was a failure without major complication in four patients (4%), and was a failure with major complication (death, MI, and emergency surgery) in 58 patients (56%). The overall mortality rate was 6% (six patients), the overall MI rate was 36% (37 patients), and emergency bypass surgery was required in 30% of patients (31 patients). At 6 months' follow-up of 42 patients with successful management, recurrent angina pectoris due to restenosis occurred in 10 patients (24%), and a late MI occurred in one patient (3%). At 6 months' follow-up of 56 survivors with unsuccessful management (development of MI or need for emergency bypass surgery), recurrent angina occurred in nine patients (16%), and cardiac death in two patients (4%). However, the majority of patients in both groups were either symptom free or had mild angina pectoris. CONCLUSION. Acute coronary artery occlusion during PTCA is often unpredictable, but its frequency is higher in patients with unstable angina, multivessel disease, and complex lesions. Despite immediate redilatation, use of intracoronary streptokinase, and emergency bypass surgery, PTCA is associated with a high mortality and morbidity. http://repub.eur.nl/res/pub/4413/ 1991-01-01T00:00:00Z The incidence of major complications after percutaneous coronary angioplasty (PTCA) of a totally occluded artery was assessed retrospectively. A total of 1649 PTCA procedures were analyzed. After exclusion of procedures for acute myocardial infarction or total occlusion that resulted from restenosis, 90 patients were selected. Forty-four patients (49%) had stable angina and 46 (51%) had unstable angina. The estimated duration of occlusion was 87 +/- 78 days in patients with stable angina, as compared with 10 +/- 8 days in patients with unstable angina (p less than 0.001). Abrupt vessel closure during PTCA occurred only in patients with unstable angina (0% versus 17%, p less than 0.05). The major complication rate was 2.5% in the stable angina group, and 20% in unstable angina group (p less than 0.01). This rate was also significantly higher than the complication rate of 8% observed in 442 procedures that were performed during the same period in patients with the unstable angina and nonocclusive stenosis (p less than 0.01). Patients with unstable angina who undergo PTCA of a totally occluded artery represent a subset of high risk for major complications. http://repub.eur.nl/res/pub/4414/ 1991-01-01T00:00:00Z Between 1981 and 1988, 107 percutaneous transluminal coronary angioplasty (PTCA) procedures, including repeat PTCA, were performed in 84 patients with previous coronary artery bypass grafting (CABG). Fifty-nine patients underwent a first angioplasty of the vein graft alone, and 25 underwent a first PTCA of the graft and one or more native vessels. Seventeen patients underwent two procedures, four patients three procedures and one patient four procedures. In 84 first angioplasties, 133 lesions were attempted; 40 lesions in native vessels and 93 graft lesions (28 ostial stenoses, 33 shaft stenoses, and 32 stenoses at the distal anastomosis). Three patients died during their hospital stay. Two patients underwent emergency CABG. Seven patients sustained an acute myocardial infarction (AMI), among whom five underwent a PTCA of an occluded vessel. The clinical primary success rate per patient was 82%. After five years, 70% of patients were alive. At a median follow-up of 2.1 years, 41% of patients were alive and event-free (no AMI, no repeat CABG, no repeat PTCA). Symptomatic improvement was maintained in 36% of patients. Angioplasty of grafts may be an alternative to re-operation in selected patients with previous bypass surgery. http://repub.eur.nl/res/pub/4420/ 1991-01-01T00:00:00Z Stent implantation in native coronary arteries may be complicated by acute thrombosis, despite the use of stringent anticoagulation. Thrombotic occlusion of stented venous grafts may occur less frequently, possibly because of the larger caliber of these grafts. We report our experience with 46 stents (Wallstent, Medinvent, Lausanne, Switzerland) implanted in 35 lesions of 24 consecutive patients (mean age 64 years, range 43 to 75). Two overlapping stents were implanted in seven patients, and three overlapping stents were positioned in two. After implantation, activated partial thromboplastin time was maintained at two to three times the control level by intravenous administration of heparin (160 to 550 mg daily) until thrombotest values were reduced 5% to 10% by acenocoumarol. Impending thrombotic occlusion was recognized in two suboptimally anticoagulated patients: patient A after implantation of four stents and patient B after anticoagulation therapy was discontinued because of acute upper gastrointestinal bleeding. Coronary artery bypass grafting was performed successfully in both patients. A third patient had a myocardial infarction on day 7 after stent implantation, in spite of adequate anticoagulation and optimal medical drug therapy. It is concluded that stringent anticoagulation therapy appears mandatory to maintain graft patency after stent implantation. http://repub.eur.nl/res/pub/4421/ 1991-01-01T00:00:00Z OBJECTIVE: To assess by quantitative analysis the immediate angiographic results of directional coronary atherectomy. To compare the effects of successful atherectomy with those of successful balloon dilatation in a series of patients with matched lesions. DESIGN--Case series. SETTING--Tertiary referral centre. PATIENTS--62 patients in whom directional coronary atherectomy was attempted between 7 September 1989 and 31 December 1990. INTERVENTIONS--Directional coronary atherectomy. MAIN OUTCOME MEASURES--Increase in minimal luminal diameter of coronary artery segment. RESULTS--Angiographic success on the basis of intention to treat was obtained in 54 patients (87%). In four patients the lesion could not be crossed by the atherectomy device; all four had an uneventful conventional balloon angioplasty. Four of the 58 patients who underwent atherectomy were subsequently referred for coronary bypass surgery because of failure or complications; three of them sustained a transmural infarction. In the successful cases, coronary atherectomy resulted in an increase in the minimal luminal diameter from 1.1 mm to 2.5 mm with a concomitant decrease of the diameter stenosis from 62% to 22%. In the subset of 37 patients in which the changes induced were compared with conventional balloon angioplasty atherectomy increased the minimal luminal diameter more than balloon angioplasty (1.6 v 0.8 mm; p less than 0.0001). Conventional histology showed media or adventitia in 26% of the atherectomy specimens. In hospital complications occurred in six patients who had undergone a successful procedure: two transmural infarctions, two subendocardial infarctions, one transient ischaemia attack, and one death due to delayed rupture of the atherectomised vessel. All patients were clinically evaluated at one and six months. One patient had persisting angina (New York Heart Association class II), one patient sustained a myocardial infarction, one patient underwent a percutaneous transluminal coronary angioplasty for early restenosis, and one patient underwent coronary bypass surgery because of a coronary aneurysm formation. At six months 80% (36/47) of the patients were symptom free. CONCLUSIONS--Coronary atherectomy achieved a better immediate angiographic result than balloon angioplasty; however, in view of the complication rate in this preliminary series, which may be related to a learning curve, a randomised study is needed to show whether this procedure is as safe as a conventional balloon angioplasty. http://repub.eur.nl/res/pub/4436/ 1991-01-01T00:00:00Z To determine functional and anatomic changes in the first 24 hours after coronary angioplasty, we studied at random 15 patients (9 men, mean age 60 years) who underwent coronary angioplasty of 16 coronary arteries. Quantitative coronary angiography and coronary flow reserve measurements from digitized coronary angiograms were performed before, immediately after, and 24 hours after coronary angioplasty. Calculated were the minimal luminal diameter, obstruction area, and percentage diameter stenosis from two preferably orthogonal projections. Prior myocardial infarction in the myocardial region of interest was present in four patients. Seven patients had multivessel disease. Collateral vessels supplying the compromised flow region were observed in three patients. Six patients had refractory unstable angina pectoris. After coronary angioplasty, angiographically visible dissection was noted in six patients, whereas side branch occlusion was observed in one. Minimal luminal diameter before, immediately after, and 24 hours after was 0.93 +/- 0.18 mm, 1.53 +/- 28 mm, and 1.53 +/- 0.21 mm, respectively; obstruction area was 0.70 +/- 0.26 mm2, 1.92 +/- 0.69 mm2, and 1.87 +/- 0.51 mm2, respectively; diameter stenosis was 60.4 +/- 8.0%, 36.8 +/- 11.4%, and 37.6 +/- 5.3%, respectively. The coronary flow reserve (lower limit of normal with this technique 3.4) was essentially the same before and immediately after coronary angioplasty (1.26 +/- 0.59 vs 1.30 +/- 0.42, p = NS) with a slight improvement to 1.78 +/- 0.90 (p less than 0.05) 1 day later. Coronary artery dimensions correlated poorly with coronary blood flow reserve before and after angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS) http://repub.eur.nl/res/pub/4374/ 1990-01-01T00:00:00Z http://repub.eur.nl/res/pub/4382/ 1990-01-01T00:00:00Z To determine the costs of a procedure, the total costs of the department that provides the service must be considered and, in addition, the direct cost of the specific procedure. Applying this principle to the cost accounting of angioplasty and bypass surgery results in a direct, i.e. procedural, cost, including the initial hospital stay, of respectively 8694 Dfl and 20,987 Dfl. A review of the follow-up data for the first year after the original intervention revealed a 2% reintervention rate for bypass surgery, while this percentage was 29% for angioplasty. Adding the first year costs involved with reinterventions to the procedural costs results in a 1-year cost of angioplasty and bypass operation of 13,625 Dfl and 21,363 Dfl, respectively. It is concluded that because of reinterventions in the first year, a mark up of 57% on the procedural cost of angioplasty must be added to cover 1-year costs, while for bypass surgery this is only 1%. Nevertheless, the 1-year cost for angioplasty is still 36% less than for bypass surgery. As reinterventions after PTCA may stay considerably higher than for CABG for several years, the mark-up percentages will be substantially higher for longer time spans. This may tend to equalize the total costs of PTCA and CABG over time spans of perhaps 5-8 years. Sufficient data are not available to verify this statement. Clinicians must realize that choosing the most appropriate procedure is not only a matter of medical assessment but also a matter of cost effectiveness. CABG can be seen as an 'investment decision' while PTCA tends to become a decision with characteristics of 'maintenance planning'! http://repub.eur.nl/res/pub/4384/ 1990-01-01T00:00:00Z More aggressive therapy has been suggested for patients who have a non-Q wave myocardial infarction (MI) because of the frequency of subsequent unstable angina, recurrent MI, and high mortality rate compared to patients with Q wave MI. The present study was undertaken to investigate the effect of coronary angioplasty on regional myocardial function of the infarct zone in patients with angina early after a non-Q wave MI. The study population consisted of 36 patients undergoing successful coronary angioplasty within 30 days of a non-Q wave MI, in whom sequential left ventricular angiograms of adequate quality were obtained before the initial procedure and at follow-up angiography. The global ejection fraction increased significantly from 60 +/- 9% to 67 +/- 6% (p = 0.0003). This significant increase in the global ejection fraction was primarily due to a significant improvement in the regional myocardial function of the infarct zone. The results of the present study show not only that ischemic attacks early after a non-Q wave MI may lead to prolonged regional myocardial dysfunction but more important that this depressed myocardium has the potential to achieve normal contraction after successful coronary angioplasty. http://repub.eur.nl/res/pub/4386/ 1990-01-01T00:00:00Z http://repub.eur.nl/res/pub/4393/ 1990-01-01T00:00:00Z Little is known about the elastic behavior of the coronary vessel wall directly after percutaneous transluminal coronary angioplasty (PTCA). Minimal luminal cross-sectional areas of 151 successfully dilated lesions were studied in 136 patients during balloon inflation and directly after withdrawal of the balloon. The circumvent geometric assumptions about the shape of the stenosis after PTCA, a videodensitometric analysis technique was used for the assessment of vascular cross-sectional areas. Elastic recoil was defined as the difference between balloon cross-sectional area of the largest balloon used at the highest pressure and minimal luminal cross-sectional area after PTCA. Mean balloon cross-sectional area was 5.2 +/- 1.6 mm2 with a mean minimal cross-sectional area of 2.8 +/- 1.4 mm2 immediately after inflation. Oversizing of the balloon (balloon artery ratio greater than 1) led to more recoil (0.8 +/- 0.3 vs 0.6 +/- 0.3 mm, p less than 0.001), suggestive of an elastic phenomenon. A difference in recoil of the 3 main coronary branches was observed: left anterior descending artery 2.7 +/- 1.3 mm2, circumflex artery 2.3 +/- 1.2 mm2 and right coronary artery 1.9 +/- 1.5 mm2 (p less than 0.025). The difference was still statistically significant if adjusted for reference area. Thus, nearly 50% of the theoretically achievable cross-sectional area (i.e., balloon cross-sectional area) is lost shortly after balloon deflation. http://repub.eur.nl/res/pub/4397/ 1990-01-01T00:00:00Z -- http://repub.eur.nl/res/pub/4316/ 1989-01-01T00:00:00Z The response of myocardial lactate and hypoxanthine metabolism during percutaneous transluminal coronary angioplasty was studied in a series of 15 patients undergoing this procedure. A minimum of 4 balloon inflations was performed per patient with an average duration per occlusion of 49 +/- 11 seconds (mean +/- standard deviation) for a total occlusion time of 192 +/- 40 seconds. Thermodilution coronary venous blood flow measured in the great cardiac vein decreased from control values of 72 +/- 4 ml/min (mean +/- standard error of the mean) to 47 +/- 10 ml/min with the fourth coronary occlusion (p less than 0.005). Arteriovenous lactate and hypoxanthine showed peak differences during the reactive hyperemia after the first 2 occlusions which did not increase after subsequent occlusions. Within minutes after the procedure, lactate and hypoxanthine efflux was no longer seen, demonstrating the reversibility of the metabolic disturbances after repeated ischemia. The results of this study indicate that there is no permanent alteration in lactate or hypoxanthine metabolism after percutaneous transluminal coronary angioplasty with 4 coronary occlusions of 40 to 60 seconds' duration, with a total occlusion time of 192 +/- 40 seconds. http://repub.eur.nl/res/pub/4330/ 1989-01-01T00:00:00Z The first 840 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) performed in the same institution were retrospectively assessed at an average follow-up period of 25 months after the initial procedure. The study population consisted of 506 patients with stable angina pectoris (group 1) and 334 patients with unstable angina pectoris (group 2). Clinical end points were death, nonfatal myocardial infarction, recurrent angina pectoris necessitating bypass surgery or repeat PTCA, and event-free survival. The two groups were comparable with respect to age, sex, previous myocardial infarction, ejection fraction, and number of diseased vessels. PTCA was successful in 83.0% of group 1 and 87.1% of group 2. Follow-up rates were expressed as events per attempted PTCA in a patient group. No difference in survival was observed between the two groups, the mortality rate being approximately 2.8% at 25 months. In the group with stable angina pectoris there was a lower incidence of nonfatal myocardial infarction within the first 24 hours after angioplasty; 4.3% vs 9.0% (p less than 0.01). During long-term follow-up the increase in the incidence of nonfatal myocardial infarction was similar, resulting in an overall long-term follow-up infarction rate of 8.3% and 14.2%, respectively (p less than 0.01). A higher event-free survival was observed in group 1 within 24 hours after PTCA: 93.7% vs 84.2% (p less than 0.01). During subsequent follow-up the difference in event-free survival between the two groups was no longer significant: 68.5% vs 61.2%.(ABSTRACT TRUNCATED AT 250 WORDS) http://repub.eur.nl/res/pub/4334/ 1989-01-01T00:00:00Z -- http://repub.eur.nl/res/pub/4275/ 1988-01-01T00:00:00Z Despite initially favorable prognosis in patients with non-Q-wave acute myocardial infarction (AMI), long-term mortality in this subset of patients appears to be similar to or even greater than that in patients with Q-wave AMI. The relatively poor late prognosis is primarily due to a high incidence of unstable angina and recurrent AMI. Between January 1982 and January 1987, 114 patients with suitable coronary narrowing underwent percutaneous transluminal coronary angioplasty (PTCA) for angina pectoris (present either at rest or during mild exertion, and despite optimal pharmacologic therapy), a median of 31 (range 2 to 362) days after a non-Q-wave AMI. Success was achieved in dilating the obstructed artery in 98 patients (113 of the 129 dilated arteries). Emergency bypass surgery was performed in 7 patients. Mean clinical follow-up of 20 (range 3 to 59) months was obtained in all patients and revealed no deaths. Of the 98 patients with successful PTCAs, 6 (6%) developed a nonfatal recurrent AMI and 62 (63%) were asymptomatic. However, recurrent angina affected 31 patients (32%) and was treated by repeat PTCA (n = 18), coronary bypass surgery (n = 5) or pharmacologic therapy (n = 8). At follow-up, 74% of the patients (73 of 98) were asymptomatic after a successful PTCA and, if necessary, a repeat PTCA, without incidence of recurrent AMI, coronary bypass surgery or death. The high initial success rate, low incidence of subsequent death and late recurrent AMI and sustained symptomatic benefit suggest that PTCA is an effective initial treatment strategy in these selected patients. http://repub.eur.nl/res/pub/4276/ 1988-01-01T00:00:00Z To investigate the clinical usefulness of intracoronary Doppler recordings during percutaneous transluminal coronary angioplasty (PTCA), the changes of intracoronary blood flow velocity during PTCA were assessed in 20 patients with single proximal coronary stenosis, using a Doppler probe end-mounted on the tip of a PTCA catheter. A mean of 4 inflations was performed in each patient. Intracoronary velocities were measured before and after each inflation and during peak reactive hyperemia after each transluminal occlusion. Quantitative analysis of the coronary stenosis was assessed before and after PTCA, and the dilatation resulted in an increase in minimal luminal cross-sectional area from 1.1 +/- 0.8 to 2.7 +/- 1.2 mm2. A gradual and significant improvement in velocities was observed after the first 3 dilatations, but in 15 of the 20 patients the resting and hyperemic velocities were not affected by the fourth dilatation. Coronary flow reserve measured during reactive hyperemia after the last dilatation with the PTCA catheter across the lesion was 1.9. This value of coronary flow reserve is compatible with the residual stenosis measured after PTCA when corrected for the presence of the Doppler balloon catheter (0.68 mm2). This application of the Doppler technique may provide a new method of on-line functional monitoring of the PTCA procedure in individual patients, but does not yet allow an accurate prediction of the change in coronary geometry brought about by PTCA. http://repub.eur.nl/res/pub/4277/ 1988-01-01T00:00:00Z Coronary hemodynamics and vasodilatory effects on major epicardial arteries were investigated after a single dose of nicorandil in 22 patients undergoing cardiac catheterization for suspected coronary artery disease. Nicorandil, 20 mg, was administered sublingually to 11 consecutive patients and 40 mg to 11 others. Systemic blood pressure decreased significantly without affecting the heart rate. Coronary sinus blood flow did not change significantly. As the mean aortic pressure decreased significantly by 13% after 20 mg and 21% after 40 mg of nicorandil, the calculated coronary vascular resistance decreased but did not reach statistical significance. There was a decrease in myocardial oxygen consumption (-14% and -22%, respectively), and this was consistent with a significant decrease in the calculated pressure-rate product of 19% and 24%, respectively. A total of 103 selected coronary segments, including 17 stenotic segments, were analyzed quantitatively using a computer-assisted coronary angiography analysis system. After 20 or 40 mg of nicorandil, a significant increase of the mean diameter was observed in the proximal (+9% and +7%), midportion (+10% and +11%) and distal (+15% and +13%) parts of the left anterior descending coronary artery. Corresponding values for the proximal (+13% and +10%) and distal (+10% and +15%) segments of the circumflex artery were observed. An increase in the obstruction diameter was also observed in all but 3 of the analyzed stenotic segments. The results demonstrate that nicorandil, in the route and doses used, causes a significant vasodilation in the major epicardial coronary segments, including most stenotic segments, and decreases the myocardial oxygen demand with little effect on the resistance vessels. http://repub.eur.nl/res/pub/4282/ 1988-01-01T00:00:00Z Immediate PTCA following thrombolysis with streptokinase was performed in 46 out of 533 patients enrolled in a multicentre randomized trial of early reperfusion in patients with acute myocardial infarction. Additional effects of PTCA in patients with a residual diameter stenosis in the infarct-related coronary artery of 70% or more after thrombolysis were compared with successful thrombolysis alone in a matched pair analysis. Thirty six pairs of patients were formed identical with respect to the infarct related coronary artery, presence or absence of previous myocardial infarction, total ST segment elevation on the ECG at admission to the trial, and delay between onset of symptoms and hospital admission. PTCA after thrombolysis did not lead to additional limitation of infarct size, nor to further preservation of left ventricular function. Infarction rate during the three-year follow-up was 14% after PTCA versus 30% after thrombolysis alone (P = 0.05). Similarly, patients had less angina or heart failure after PTCA, since on average 128 out of 156 weeks follow-up were symptom free, while this was only 102 weeks after thrombolysis alone (P = 0.03). Immediate PTCA after thrombolysis with intracoronary streptokinase seems to prevent recurrent ischemia and reinfarction. Further studies should address the proper indication and timing of PTCA after thrombolysis. http://repub.eur.nl/res/pub/4290/ 1988-01-01T00:00:00Z Two hundred patients (mean age 56 years, range 36 to 74) with unstable angina (chest pain at rest, associated with ST-T changes) underwent coronary angioplasty. In 65 patients with multivessel disease, only the "culprit" lesion was dilated. The initial success rate was 89.5% (179 of 200 patients). At least one major procedure-related complication occurred in 21 patients (10.5%): (death in 1, myocardial infarction in 16 and urgent surgery in 18). All patients were followed up for 2 years. Five patients died late; 8 had a late nonfatal myocardial infarction and 52 had recurrence of angina pectoris. The restenosis rate was 32% (51 of 158) in the patients with initial successful angioplasty who had repeat angiography. At the 2 year follow-up, after attempted coronary angioplasty in all 200 patients, the total incidence rate of death was 3% (one procedure related; five late deaths), of nonfatal myocardial infarction 12% (16 procedure related and 8 late after angioplasty), and 13% (26 patients) were still symptomatic although they had improved in functional class. Multivariate analysis showed that variables indicating an increased risk 1) for major procedure-related complications were: ST segment elevation, persistent negative T wave and stenosis greater than or equal to 65% (odds ratio 3.7, 3.7 and 3.3, respectively); 2) for angiographic restenosis were: presence of collateral vessels, ST segment depression, multivessel disease, left anterior descending coronary artery stenosis and history of recent onset of symptoms (odds ratio: 2.2, 2.0, 1.9, 1.9 and 0.54, respectively); and 3) for late coronary events (recurrence of angina, late myocardial infarction or late death) were: multivessel disease, total occluded vessel and ST segment elevation (odds ratio 3.7, 2.8 and 0.44, respectively). Thus, coronary angioplasty for unstable angina can be performed with a high initial success rate, but at an increased risk of major complications. The prognosis is favorable after initial successful coronary angioplasty. http://repub.eur.nl/res/pub/4306/ 1988-01-01T00:00:00Z Management of unstable angina has evolved progressively, and coronary angioplasty has recently been shown to be an effective treatment strategy for unstable angina. However, the procedure-related major complication rate is higher when compared with that for angioplasty in stable angina. The underlying pathophysiology may explain this higher complication rate. Rupture of an atherosclerotic plaque associated with thrombus formation is frequent in the pathogenesis of unstable angina. These processes lead to a critical reduction in myocardial blood supply, and coronary angioplasty may effectively interrupt this process. In contrast, coronary angioplasty itself may cause further injury of the already ulcerated intima, have the potential to intensify the ongoing thrombogenic process and lead to an increased frequency of abrupt closure of the artery during the procedure. Therefore, intracoronary streptokinase was used in the procedure in those patients with abrupt closure of the artery immediately after dilation to attempt to improve the immediate result. Coronary angioplasty was attempted in 200 consecutive patients with unstable angina. Initial success in crossing the obstructed artery was achieved in 196 patients; however, an abrupt closure immediately after dilation occurred in 21 of these patients. Of these 21 patients, 12 were also treated with intracoronary streptokinase, and successful dilation was achieved in 9 patients without evidence of necrosis or the need for emergency bypass surgery. Of the remaining nine patients, four successfully underwent redilation with a larger-sized balloon, four underwent urgent surgery (one death postoperatively) and one was treated conventionally. Final success was achieved in 188 patients (94%) without death, the need for emergency surgery or evidence of myocardial necrosis.(ABSTRACT TRUNCATED AT 250 WORDS) http://repub.eur.nl/res/pub/4240/ 1987-01-01T00:00:00Z -- http://repub.eur.nl/res/pub/4242/ 1987-01-01T00:00:00Z Coronary angioplasty (PTCA) was performed early after diagnosis of unstable angina in 71 patients who responded favorably with initial pharmacologic treatment and who also had persistent exertional angina. The patients selected for PTCA had predominantly single-vessel disease and a normal or slightly abnormal left ventricular function. PTCA was successful in 87% (62/71) of the patients and unsuccessful in 13% (9/71). There were no deaths related to PTCA. The incidence of myocardial infarction during the procedure was 10% (seven of the 71 patients). Urgent bypass surgery was necessary in 11% (eight of 71 patients) of the patients. All patients were followed up for 12 months. There was one late death and one late nonfatal myocardial infarction. During 12 months of follow-up there was recurrence of angina pectoris in 25% of the patients (14/62). The restenosis rate was 25% (13/52) in the patients with an initial successful PTCA who underwent repeat angiography. Improved cardiac functional status after sustained successful PTCA was demonstrated by the normal exercise capacity on bicycle exercise testing and the absence of ischemia on thallium 201 scintigraphy studies in 70% of the patients. At the 1-year follow-up visit after attempted coronary angioplasty in all 71 patients, the total incidence of deaths was 1.5% (one patient), myocardial infarction 11% (eight patients), and the need for revascularization 25% (emergency surgery eight patients, late surgery three patients, and repeat PTCA seven patients); 91% (64 of 70 patients) were symptom free. It is concluded that PTCA in selected patients with unstable angina initially stabilized with medical treatment is an effective treatment with an acceptable complication rate and an excellent 1-year prognosis. http://repub.eur.nl/res/pub/4249/ 1987-01-01T00:00:00Z A total of 533 patients with acute myocardial infarction of less than 4-h duration were enrolled in the multicenter randomized trial of intracoronary thrombolysis compared to conventional treatment. In two of the five participating centers, an additional coronary angioplasty immediately after thrombolysis was attempted in 46 patients. According to the treatment allocation and early and late patency of the infarct related vessel, patients were subdivided into three groups: conventionally treated (group A); successful coronary angioplasty following thrombolysis with persistent patent infarct related vessel (group B); and late patency of the infarct related vessel postthrombolytic therapy without angioplasty (group C). The highest global ejection fractions were observed in group B (54% +/- 10%) and group C (55% +/- 13%), while the lowest ejection fraction was found in group A (47% +/- 14%). The sequential changes in global ejection fraction from the acute to the chronic stage was + 4% (p = 0.05) in group B, while no significant changes could be demonstrated in group C. Furthermore, in the group successfully treated by angioplasty, the improvement in global ejection fraction was more pronounced and persisted up to three months after the intervention. This was supported by analysis of regional myocardial function of the infarct zone (+ 16% improvement, p = 0.01). The long-term clinical follow-up (median 24 months) of the patients successfully treated by combined procedure of thrombolysis and angioplasty (group B) was most favourable with a lower incidence of re-infarction (6%), and late coronary bypass surgery (13%) and/or (re)-percutaneous transluminal coronary angioplasty (3%) was performed less frequently. These results suggest that reperfusion may need to be supplemented by additional revascularization procedures in order to optimize the changes of obtaining full functional recovery and so to improve the prognosis. http://repub.eur.nl/res/pub/4257/ 1987-01-01T00:00:00Z http://repub.eur.nl/res/pub/4260/ 1987-01-01T00:00:00Z Sixty-eight patients (58 men, 10 women, mean age 56.3 years, range 31 to 72) with unstable angina pectoris, either initially stabilized with or refractory to optimal pharmacologic treatment, were studied to determine whether regional dysfunction due to stunning of the myocardium caused by attacks of chest pain at rest could be improved with percutaneous transluminal coronary angioplasty (PTCA). Patients were included in the study if they had successful 1-vessel PTCA, no angiographic restenosis, no reocclusion or late myocardial infarction and 2 serial left ventriculograms of sufficient quality to allow automated contour analysis before and after PTCA. Global ejection fraction increased significantly (from 56% to 60%, p less than 0.05) only after successful dilatation of a stenosis of the left anterior descending coronary artery. Analysis of regional wall displacement showed significant improvement of regional wall motion in the areas supplied by the dilated vessel of either the left anterior descending, the left circumflex or the right coronary artery. Thus, regional myocardial dysfunction due to stunning of the myocardium in patients with unstable angina improves after successful PTCA. http://repub.eur.nl/res/pub/5309/ 1987-01-01T00:00:00Z In this overview the characteristics have been defined of those patients with acute myocardial infarction to whom early thrombolytic therapy would offer a major benefit. However, this concerns only the 20% of all patients who are admitted to the hospital with acute myocardial infarction within the specified time limit. It is still unclear whether later thrombolytic therapy with the newer agents might offer benefit to other patients with acute myocardial infarction. Presently, it seems unlikely that patients admitted to the hospital more than six hours after onset of symptoms will benefit from any reperfusion strategy. Patients admitted up to 24 hours after onset of symptoms with symptomatic and extensive ischemia (usually located anteriorly) or with signs of cardiogenic shock constitute a group of high risk patients who might derive further benefit from late reperfusion (42). It is likely that in the near future the new generation of thrombolytic agents (rt-PA, rscu-PA and APSAC) will become first choice for the intravenous initiation of thrombolytic therapy. Then, the indications for either acute or delayed angiography might be different from the present ones. Further cost/benefit analysis will certainly be required to assess the additional value of intracoronary thrombolysis and coronary angioplasty after intravenous administration of rt-PA, rscu-PA or APSAC. The required capacity of catheterization laboratories and facilities for coronary angioplasty and bypass surgery will depend on the results of those analyses.(ABSTRACT TRUNCATED AT 250 WORDS) http://repub.eur.nl/res/pub/4184/ 1986-01-01T00:00:00Z The effect of early myocardial reperfusion (within 4 hours after onset of symptoms) on regional left ventricular function in patients with acute myocardial infarction has been quantitated by analysis of segmental wall motion. Of 533 patients randomized either to conventional coronary care unit therapy or to a reperfusion strategy, in 332 high quality angiograms were obtained 2 to 8 weeks after the onset of myocardial infarction. In those assigned to thrombolytic therapy, angiographic data were also available after acute reperfusion. Analysis on an "intention to treat" basis revealed significant preservation of left ventricular function after thrombolytic therapy (ejection fraction 53%) compared with conventional treatment (ejection fraction 47%). In addition, wall motion analysis showed significant improvement of regional function in the infarct zone in both inferior and anterior infarction. In addition, significant changes occurred in regional function of the remote "noninfarct zone" in the acute as well as the chronic stage. It is concluded that improved regional and global left ventricular function can be achieved with early reperfusion and that this is the likely explanation for the reduction of early and late mortality after thrombolysis observed in this study. http://repub.eur.nl/res/pub/4158/ 1985-01-01T00:00:00Z The hemodynamic effects of diltiazem were investigated in 15 patients with suspected coronary artery disease undergoing routine cardiac catheterization. Diltiazem was given in a high dose of 500 micrograms/kg over a period of 5 min and measurements made before and after drug administration during spontaneous heart rate and during matched atrial pacing. Spontaneous heart rate did not change (-5%; NS). Left ventricular (LV) systolic pressure decreased 24% (p less than 10(-6)) and LV end-diastolic pressure (LVEDP) did not change (-5%; NS). During coronary blood flow measurement, mean aortic pressure decreased 30% (p less than 10(-6)) as global (coronary sinus) and regional (great cardiac vein) coronary vascular resistance diminished with no change in coronary blood flow. Myocardial oxygen consumption decreased 19% (p less than 0.02). During matched pacing, although no change occurred in calculated systolic isovolumic indexes of contractility, end-systolic pressure-volume index decreased 15% (p less than 0.05). The time constant of isovolumic relaxation assessed by a biexponential model decreased. No net change occurred in either global or regional wall motion. In summary, high-dose diltiazem was administered safely to patients with coronary artery disease. It is concluded that, at this dose, diltiazem acted as a peripheral and coronary vasodilator. Hemodynamic changes consistent with a direct negative inotropic and chronotropic effect of the drug were observed. Myocardial oxygen consumption decreased with no change in coronary blood flow. http://repub.eur.nl/res/pub/4159/ 1985-01-01T00:00:00Z The effect of myocardial reperfusion on regional left ventricular function has been quantitated by analysis of segmental wall motion in 185 patients enrolled in a randomized trial comparing thrombolysis with conventional treatment in patients with acute myocardial infarction. When analyzing the hemodynamic data on an "intention to treat" basis we found a significant preservation of left ventricular function after thrombolytic therapy when compared to conventional treatment. In addition, the wall motion analysis showed that a significant improvement of regional function in the "infarct zone" was observed in inferior infarction as well as in anterior infarction, although significant changes in regional function of the remote "non infarct zone" were observed at the acute as well as at the chronic stage. However, our follow-up data indicate that as yet it has not been resolved whether this method of treatment does indeed improve prognosis in patients with acute myocardial infarction. Accordingly, we maintain the view that such invasive treatment should not be generally applied until more follow-up data become available from larger randomized trials. http://repub.eur.nl/res/pub/4172/ 1985-01-01T00:00:00Z The hemodynamic effects of nisoldipine and diltiazem were investigated in two groups of patients undergoing investigation for suspected coronary artery disease. Emphasis was placed on the coronary hemodynamic changes. Approximately equihypotensive doses of these two calcium channel blockers, nisoldipine (6 micrograms/kg) and diltiazem (500 micrograms/kg) were given intravenously. Although both drugs decreased peak systolic pressure by 28% and 24%, respectively, heart rate increased with nisoldipine (68 +/- 9 to 82 +/- 12 bpm) and remained unchanged with diltiazem (70 +/- 9 to 67 +/- 10 bpm). Nisoldipine increased mean coronary sinus blood flow from 146 +/- 40 to 176 +/- 35 ml/min and great cardiac vein flow from 87 +/- 20 to 109 +/- 24 ml/min, producing a significant reduction in the calculated global (from 0.79 +/- 0.2 to 0.43 +/- 0.12 mmHg min/ml) and regional (from 1.43 +/- 0.2 to 0.70 +/- 0.13 mmHg min/ml) coronary vascular resistances. There were no significant flow changes when corrected for heart rate. Global and regional myocardial oxygen consumptions were not significantly altered. Diltiazem had no significant effects on heart rate or global and regional blood flows, although the vascular resistances decreased by 32% and 35%, respectively. Diltiazem reduced global and regional arterio-coronary sinus oxygen differences, resulting in significant decreases in global (from 14.9 +/- 4.7 to 12.1 +/- 2.3 ml/min) and regional (from 5.6 +/- 0.9 to 5.2 +/- 1.2 ml/min) myocardial oxygen consumptions. The major difference between the drugs was in heart rate, despite the similar reductions in aortic pressure. The lack of a positive chronotropic response after diltiazem may explain the reduction in myocardial oxygen consumption. http://repub.eur.nl/res/pub/4175/ 1985-01-01T00:00:00Z The hemodynamic effects of nisoldipine were investigated in 16 patients with suspected coronary artery disease who underwent routine cardiac catheterization. Nisoldipine was given intravenously in a dose of 6 micrograms/kg over 3 minutes and measurements made before and after drug administration during spontaneous and matched atrial paced heart rate. During sinus rhythm, nisoldipine produced a significant increase in heart rate (19%, p less than 10(-5]. Left ventricular systolic pressure decreased 28% (p less than 10(-6) and left ventricular end-diastolic pressure did not change significantly (5%, difference not significant). Coronary sinus and great cardiac vein blood flow increased by 21% (p less than 0.02) and 25% (p less than 0.005), respectively, after nisoldipine administration. Simultaneously, mean aortic pressure decreased 33% (p less than 10(-6]; consequently, the global and regional coronary vascular resistances decreased by 50% (p less than 10(-4]. The decreases in global (-8%) and regional (-4%) myocardial oxygen consumption did not reach statistical significance. A 6% (not significant) increase in end-diastolic volume and an 11% (p less than 0.002) decrease in end-systolic volume resulted in an increase of 21% in stroke volume (p less than 10(-4] with a consistent increase in ejection fraction (+16%, p less than 10(-5]. Total systemic vascular resistance was reduced by 30% (p less than 0.0002). During spontaneous heart rate and matched atrial pacing, the time constant of isovolumic relaxation as assessed by a biexponential model, was significantly shortened.(ABSTRACT TRUNCATED AT 250 WORDS)