http://repub.eur.nl/res/aut/2291/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/28715/ 2010-12-01T00:00:00Z Objectives: The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES). Background Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported. Methods In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis. Results At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortiumdefined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43). Conclusions In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310) (SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479) http://repub.eur.nl/res/pub/21817/ 2010-11-01T00:00:00Z Background: Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods: The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed. Results: The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. http://repub.eur.nl/res/pub/13300/ 2004-02-24T00:00:00Z BACKGROUND: Restenosis and consequent adverse cardiac events are increased in diabetics undergoing percutaneous coronary intervention. Use of intracoronary stents may ameliorate such risks; however, factors influencing the likelihood of restenosis after stent deployment in this high-risk patient subgroup are unknown. METHODS AND RESULTS: We retrospectively analyzed all stented diabetic patients in 16 studies of percutaneous coronary intervention, all of which underwent core angiographic analysis at Cardialysis, Rotterdam. Univariate and multivariate analyses, with 37 clinical and angiographic variables, compared those with and without restenosis and predicted restenosis rates calculated through the use of reference charts derived from angiographic data. Within the studies, 418 of 3090 (14%) stented patients with 6-month angiographic follow-up had diabetes. Restenosis (> or =50% diameter stenosis at follow-up) occurred in 550 of 2672 (20.6%) nondiabetic and 130 of 418 (31.1%) diabetic patients (P<0.001). Univariate predictors of restenosis in diabetics were smaller vessel reference diameter (RD) (P<0.001), smaller minimal luminal diameter before stenting (P=0.01), smaller minimal luminal diameter and percent diameter stenosis after stenting (P<0.001, P=0.04), greater stented length of vessel (P<0.001), and reduced body mass index (BMI) (P=0.04). With the use of multivariate analysis, only smaller RD (P=0.003), greater stented length of vessel (P=0.04), and reduced BMI (P=0.04) were associated with restenosis. Reference charts demonstrated an incremental risk of restenosis that appears solely dependent on vessel RD. CONCLUSIONS: Restenosis after stent deployment is significantly increased in diabetic patients. Vessel caliber, stented length of vessel, and lower BMI are predictors of in-stent restenosis in patients with diabetes. Furthermore, vessel caliber affected the predicted risk of restenosis incrementally. http://repub.eur.nl/res/pub/9787/ 2001-01-01T00:00:00Z BACKGROUND: Angiographic restenosis after percutaneous coronary interventional procedures is more common than recurrent angina. Clinical and angiographic factors associated with asymptomatic versus symptomatic restenosis after percutaneous coronary intervention were compared. METHODS AND RESULTS: All patients with angiographic restenosis from the BENESTENT I, BENESTENT II pilot, BENESTENT II, MUSIC, WEST 1, DUET, FINESS 2, FLARE, SOPHOS, and ROSE studies were analyzed. Multivariate analysis evaluated 46 clinical and angiographic variables, comparing those with and without angina. The 10 studies recruited 2690 patients who underwent percutaneous revascularization and 6-month follow-up angiography (86% of those eligible). Restenosis (>/=50% diameter stenosis) occurred in 607 patients and was clinically silent in 335 (55%). Male sex (P=0.008), absence of antianginal therapy with nitrates (P=0.0002) and calcium channel blockers (P=0.02) at 6 months, greater reference diameter after the procedure (P=0.04), greater reference diameter at follow-up (P=0.004), and lesser lesion severity (percent stenosis) at 6 months (P=0.0004) were univariate predictors of asymptomatic restenosis. By multivariate analysis, only male sex (P=0.04), greater reference diameter at follow-up (P=0.002), and lesser lesion severity at 6 months (P=0.0001) were associated with restenosis without angina. CONCLUSIONS: Approximately half of patients with angiographic restenosis have no symptoms. The only multivariate predictors of silent restenosis at 6 months were male sex, greater reference diameter at follow-up, and lesser lesion severity on follow-up angiography. 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/5018/ 1996-09-01T00:00:00Z A retrospective review of cardiac events occurring in all patients who underwent attempted coronary angioplasty in the first 5 years of our experience (1980-1985) was undertaken. Follow-up data were obtained from the civil registry, hospital records, patient, family, and referring physician. Patient survival curves were constructed and the outcome of women and men was compared. Eight hundred fifty-six patients, 172 women and 684 men with a mean age of 60.0 and 55.3 years, respectively, underwent attempted coronary angioplasty with an overall procedural success rate of 82%, 77.7% in women and 83.1% in men. Follow-up data were obtained in 837 patients (97.8%) with a mean period of 9.6 years (range 0-13.3 years). The estimated 10 year survival in women was identical to men [79%, 95% confidence interval (CI) 72.6–85.4% vs. 78%, 95% CI 74.6–81.4%] as was the 10 year event-free survival (men 36%, 95% CI 32.0–40.0% vs. women 37%, 95% CI 29.2-44.8%), with a similar proportion of major cardiac events—death, myocardial infarction, coronary artery bypass surgery, and repeat angioplasty. When women were matched to men for age and previous myocardial infarction, factors found to be associated with an adverse outcome, there was no significant difference. Additionally, outcome was compared after patients were matched for maximum nominal balloon size as an estimate of vessel size, with no significant difference between women and men. At follow-up, women complained of significantly more anginal symptoms than men (59.2% vs. 44.0%, P < 0.05) and took significantly more antianginal medication. http://repub.eur.nl/res/pub/5031/ 1996-06-01T00:00:00Z Abstract OBJECTIVES: This study reports the 10-year outcome of 856 consecutive patients who underwent attempted coronary angioplasty at the Thoraxcenter during the years 1980 to 1985. BACKGROUND: Coronary balloon angioplasty was first performed in 1977, and this procedure was introduced into clinical practice at the Thoraxcenter in 1980. Although advances have been made, extending our knowledge of the long-term outcome in terms of survival and major cardiac events remains of interest and a valuable guide in the treatment of patients with coronary artery disease. METHODS: Details of survival, cardiac events, symptoms and medication were retrospectively obtained from the Dutch civil registry, medical records or by letter or telephone or from the patient's physician and entered into a dedicated data base. Patient survival curves were constructed, and factors influencing survival and cardiac events were identified. RESULTS: The procedural clinical success rate was 82%. Follow-up information was obtained in 837 patients (97.8%). Six hundred forty-one patients (77%) were alive, of whom 334 (53%) were symptom free, and 254 (40%) were taking no antianginal medication. The overall 5- and 10-year survival rates were 90% (95% confidence interval [CI] 87.6% to 92.4%) and 78% (95% CI 75.0% to 81.0%), respectively, and the respective freedom from significant cardiac events (death, myocardial infarction, coronary artery bypass surgery and repeat angioplasty) was 57% (95% CI 53.4% to 60.6%) and 36% (95% CI 32.4% to 39.6%). Factors that were found to adversely influence 10-year survival were age > or = 60 years (> or = 60 years [67%], 50 to 59 years [82%], < 50 years [88%]), multivessel disease (multivessel disease [69%], single-vessel disease [82%]), impaired left ventricular function (ejection fraction < 50% [57%], > or = 50% [80%]) and a history of previous myocardial infarction (previous myocardial infarction [72%], no previous infarction [83%]). These factors were also found to be independent predictors of death during the follow-up period by a multivariate stepwise logistic regression analysis. Other factors tested, with no influence on survival, were gender, procedural success and stability of angina at the time of intervention. CONCLUSIONS: The long-term prognosis of patients after coronary angioplasty is good, particularly in those <60 years old with single-vessel disease and normal left ventricular function. The majority of patients are likely to experience a further cardiac event in the 10 years after their first angioplasty procedure. 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/5077/ 1995-07-27T00:00:00Z To determine the feasibility and safety of development of this new stent, we deployed 28 AVE Micro stents in 23 native coronary artery lesions in 20 patients who developed acute or threatened closure after balloon angioplasty (BA). Ten stents were deployed in the left anterior descending artery, 10 in the circumflex, and 8 in the right coronary artery. Luminal dimensions were measured using a computer-based quantitative coronary angiographic analysis system (CAAS II). Stent deployment was successful in 27 of 28 attempts (96%). In 1 patient with a threatened closure of the left anterior descending artery associated with proximal vessel tortuosity, attempted stent deployment was unsuccessful. The clinical course of the other 19 patients in whom stent deployment was successful was free of coronary reintervention, bypass surgery, and death. A myocardial infarction was observed in 2 patients (10%), in 1 of whom the stent was implanted within 24 hours after the onset of acute myocardial infarction, and in the other acute vessel occlusion was present for 58 minutes before stent implantation. No subacute occlusion was observed. Event-free survival at 30 days after stent implantation was 85% (17 of 20 patients). Minimal luminal diameter was 0.85 +/- 0.57 mm before and 1.19 +/- 0.66 mm after BA, 2.61 +/- 0.39 mm during balloon inflation, 3.26 +/- 0.46 mm during and 2.74 +/- 0.51 mm after stenting, 3.43 +/- 0.52 mm during balloon inflation after stenting (Swiss Kiss), and 2.85 +/- 0.48 mm after Swiss Kiss.(ABSTRACT TRUNCATED AT 250 WORDS) http://repub.eur.nl/res/pub/4613/ 1994-01-01T00:00:00Z Traditionally, the diagnosis of significant coronary atherosclerotic disease has relied on angiographic techniques. Both histologic analyses and, more recently, intravascular ultrasonography techniques have revealed that a significant atherosclerotic plaque load may be present in epicardial coronary arteries without significant luminal narrowing, consistent with compensatory vessel enlargement or remodeling. In patients with coronary atherosclerosis, more limited structural changes are present in the smaller resistance arterioles, whereas a decrease in luminal area with an increase in wall thickness and perivascular fibrosis are the characteristic structural changes observed in resistance arteries in the presence of systemic hypertension. Further, functional changes, such as impairment of endothelium-mediated vasodilation, are present in epicardial and resistance vessels of patients with coronary atherosclerosis and may influence the progression of this disease and development of ischemic syndromes. The introduction of two-dimensional intravascular and Doppler ultrasonography enables us to study in vivo these morphologic and functional changes. In this article, the knowledge acquired in humans on the mechanisms and clinical relevance of vascular remodeling with the use of these two ultrasonography-based techniques is reviewed. The possibility of using pharmacologic interventions to improve or normalize the vascular response to endothelium-dependent and independent vascular interventions is discussed, with special attention to the efficacy of the inhibition of the angiotensin-converting enzyme.