Morel, M-A.M.

SYNTAX score and Clinical SYNTAX score as predictors of very long-term clinical outcomes in patients undergoing percutaneous coronary interventions: A substudy of SIRolimus-eluting stent compared with pacliTAXel-eluting stent for coronary revascularization (SIRTAX) trial (Article)

2011-12-01T00:00:00Z

Aims To investigate the ability of SYNTAX score and Clinical SYNTAX score (CSS) to predict very long-term outcomes in an all-comers population receiving drug-eluting stents. Methods and resultsThe SYNTAX score was retrospectively calculated in 848 patients enrolled in the SIRolimus-eluting stent compared with pacliTAXel-Eluting Stent for coronary revascularization (SIRTAX) trial. The CSS was calculated using age, and baseline left ventricular ejection fraction and creatinine clearance. A stratified post hoc comparison was performed for all-cause mortality, cardiac death, myocardial infarction (MI), ischaemia-driven target lesion revascularization (TLR), definite stent thrombosis, and major adverse cardiac events (MACE) at 1- and 5-year follow-up. Tertiles for SYNTAX score and CSS were defined as SSLOW ≤7, 7< SSMID ≤14, SSHIGH >14 and CSSLOW ≤8.0, 8.0 17.0, respectively. Major adverse cardiac events rates were significantly higher in SSHIGH compared with SSLOW at 1- and 5-year follow-up, which was also seen at 5 years for all-cause mortality, cardiac death, MI, and TLR. Stratifying outcomes across CSS tertiles confirmed and augmented these results. Within CSSHIGH, 5-year MACE increased with use of paclitaxel- compared with sirolimus-eluting stents (34.7 vs. 21.3, P 0.008). SYNTAX score and CSS were independent predictors of 5-year MACE; CSS was an independent predictor for 5-year mortality. Areas-under-the-curve for SYNTAX score and CSS for 5-year MACE were 0.61 (0.560.65) and 0.62 (0.570.67), for 5-year all-cause mortality 0.58 (0.510.65) and 0.66 (0.590.73) and for 5-year cardiac death 0.63 (0.540.72) and 0.72 (0.630.81), respectively.ConclusionSYNTAX score and to a greater extent CSS were able to stratify risk for very long-term adverse clinical outcomes in an all-comers population receiving drug-eluting stents. Predictive accuracy for 5-year all-cause mortality was improved using CSS.Trial Registration Number: NCT00297661. Published on behalf of the European Society of Cardiology.

Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents at 1-year follow-up (Article)

2011-07-01T00:00:00Z

Objectives: The aim of this study was to compare the angiographic changes in coronary geometry of the bioresorbable vascular scaffolds (BVS) and metallic platform stent (MPS) between baseline and follow-up. Background: Coronary geometry changes after stenting might result in wall shear stress changes and adverse events. The BVS have better conformability, compared with MPS, but still modify artery geometry. It is uncertain whether the BVS resorption can restore the coronary anatomical configuration at midterm follow-up. Methods: All patients of the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions) and SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials treated with a single 3.0 × 18 mm device and imaged at baseline and 6- to 12-month follow-up were eligible. Coronary geometry changes were assessed with quantitative angiography as changes in curvature and angulation. Curvature and angulation changes between systole and diastole were investigated to assess hinging movements of the coronary artery. Results: One hundred sixty-one patients (86 BVS, and 75 MPS) were included. Baseline angiographic characteristics were similar. From post-implantation to follow-up, curvature increased 8.4% (p < 0.01) with BVS and decreased 1.9% (p = 0.54) with MPS; p = 0.01. Angulation increased 11.3% with BVS (p < 0.01) and 3.8% with MPS (p = 0.01); p < 0.01. From pre-implantation to follow-up, BVS decreased 3.4% the artery curvature (p = 0.05) and 3.9% the artery angulation (p = 0.16), whereas MPS presented with 26.1% decrease in curvature (p < 0.01) and 26.9% decrease in angulation (p < 0.01), being larger with MPS (p < 0.01, both). Hinging movements in curvature from pre-implantation to follow-up decreased 19.7% with BVS and 39.0% with MPS (p = 0.27) and decreased 3.9% with BVS and 26.9% with MPS in angulation (p < 0.01). Conclusions: At midterm follow-up, the BVS tended to restore the coronary configuration and the systo-diastolic movements to those seen before implantation. The coronary geometry remained similar to that seen at after implantation with MPS. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856)

Value of age, creatinine, and ejection fraction (acef score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS Trial (Article)

2011-02-01T00:00:00Z

Background-The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fraction+1 if creatinine >2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored. Methods and Results-The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial. Post hoc analysis was performed by stratifying clinical outcomes at the 1-year follow-up according to ACEF score tertiles: ACEFlow≤1.0225, 1.0225< ACEFmid≤1.277, and ACEFhigh>1.277. At 1-year follow-up, there was a significantly lower number of patients with major adverse cardiac event-free survival in the highest tertile of the ACEF score (ACEFlow=92.1%, ACEFmid=89.5%, and ACEFhigh=86.1%; P=0.0218). Cardiac death was less frequent in ACEFlowthan in ACEFmidand ACEFhigh(0.7% vs 2.2% vs 4.5%; hazard ratio=2.22, P=0.002) patients. Rates of myocardial infarction were significantly higher in patients with a high ACEF score (6.7% for ACEFhighvs 5.2% for ACEFmidand 2.5% for ACEFlow; hazard ratio=1.6, P=0.006). Clinically driven target-vessel revascularization also tended to be higher in the ACEFhighgroup, but the difference among the 3 groups did not reach statistical significance. The rate of composite definite, possible, and probable stent thrombosis was also higher in the ACEFhighgroup (ACEFlow=1.2%, ACEFmid=3.5%, and ACEFhigh=6.2%; hazard ratio=2.04, P=0.001). Conclusions-ACEF score may be a simple way to stratify risk of events in patients treated with percutaneous coronary intervention with respect to mortality and risk of myocardial infarction.

Impact of completeness of revascularization on the five-year outcome in percutaneous coronary intervention and coronary artery bypass graft patients (from the ARTS-II Study) (Article)

2010-11-15T00:00:00Z

The aim of this study was to compare clinical outcome at 5 years in patients with complete and incomplete revascularization treated with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents. Baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. Patients treated with PCI for incomplete revascularization were stratified according to Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score tertiles. Complete revascularization was achieved in 360 of 588 patients (61.2%) in the PCI with sirolimus-eluting stent group and 477 of 567 patients (84.1%) in the CABG group (p <0.05). There was no significant difference in 5-year survival without major adverse cardiac and cerebrovascular events (MACCEs; death, cerebrovascular accident, myocardial infarction, and any revascularization) between patients with complete and incomplete revascularization treated with PCI or CABG. Survival free from MACCEs in patients with incomplete revascularization treated with PCI was significantly lower than those with complete revascularization treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p = 0.001). The 5-year MACCE-free survival in patients with incomplete revascularization treated with PCI stratified according to SYNTAX score tertiles showed a significantly lower MACCE survival in the higher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p = 0.04) and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p = 0.02) tertiles, whereas survival between the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio 1.13, 0.60 to 2.13, log-rank p = 0.71). In conclusion, this study suggests that patients with complex coronary disease, in whom complete revascularization cannot be achieved with PCI, should be offered surgical revascularization. However, in those patients with less complex disease, PCI is a valid alternative even if complete revascularization cannot be achieved.

Bifurcation lesions: Functional assessment by fractional flow reserve vs. anatomical assessment using conventional and dedicated bifurcation quantitative coronary angiogram (Article)

2010-11-15T00:00:00Z

Background: The purpose of this study was to compare the performance of both conventional quantitative coronary angiography (QCA) and the dedicated three branch QCA model for bifurcations in the prediction of a functionally significant lesion according to fractional flow reserve (FFR) in patients with bifurcation lesions. Methods: Twenty patients with bifurcation lesions underwent coronary angiography together with a functional evaluation of both the main branch and side-branch using FFR. QCA was performed off-line with both conventional QCA software (CAASII, Pie Medical Imaging, Maastricht, The Netherlands) and three branch QCA software (CAAS5, Pie Medical Imaging, Maastricht, The Netherlands). A stenosis was considered hemodynamically significant when the FFR value was ≤0.80 and anatomically significant when the diameter stenosis was >50%. The QCA and FFR data were correlated by means of the Pearson correlation. Results: Eighteen bifurcation lesions were suitable for the QCA analysis. In the main vessel, a significant inverse correlation with FFR was seen with both conventional QCA (Pearson r = 0.52 for the MV, P = 0.02), and the three branch QCA model (Pearson r = 0.67 for the MV, P = 0.002). Conversely, in the side-branch, the correlation between QCA and FFR was only significant with the three branch QCA model (Pearson r = 0.57, P = 0.02 for the SB). Conclusions: In bifurcation lesions the correlation between the anatomic severity of a coronary stenosis and its functional significance appears to be somewhat higher when QCA is performed using the three branch model. This is most notable for side-branch stenoses which can be overestimated when using conventional QCA.

A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents (Article)

2010-11-01T00:00:00Z

Objectives The aim of this study was to assess the differences in terms of curvature and angulation of the treated vessel after the deployment of either a metallic stent or a polymeric scaffold device. Background Conformability of metallic platform stents (MPS) is the major determinant of geometric changes in coronary arteries caused by the stent deployment. It is not known how bioresorbable polymeric devices perform in this setting. Methods This retrospective study compares 102 patients who received an MPS (Multi-link Vision or Xience V, Abbott Vascular, Santa Clara, California) in the SPIRIT FIRST and II trials with 89 patients treated with the Revision 1.1 everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) from cohort B of the ABSORB (A bioabsorbable everolimus-eluting coronary stent system) trial. All patients were treated with a single 3 × 18 mm device. Curvature and angulation were measured with dedicated software by angiography. Results Both the MPS and BVS groups had significant changes in relative region curvature (MPS vs. BVS: 28.7% vs. 7.5%) and angulation (MPS vs. BVS: 25.4% vs. 13.4%) after deployment. The unadjusted comparisons between the 2 groups showed for BVS a nonsignificant trend for less change in region curvature after deployment (MPS vs. BVS: 0.085 cm-1 vs. 0.056 cm-1, p = 0.06) and a significantly lower modification of angulation (MPS vs. BVS 6.4° vs. 4.3°, p = 0.03). By multivariate regression analysis, the independent predictors of changes in curvature and angulation were the pre-treatment region curvature, the pre-treatment region angulation, and the used device. Conclusions Bioresorbable vascular scaffolds have better conformability than conventional MPS. The clinical significance of the observed differences will require further investigation.

Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (limus eluted from a durable versus ERodable stent coating) trial (Article)

2010-07-20T00:00:00Z

Objectives: We aimed to assess the predictive value of the SYNTAX score (SXscore) for major adverse cardiac events in the all-comers population of the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. Background: The SXscore has been shown to be an effective predictor of clinical outcomes in patients with multivessel disease undergoing percutaneous coronary intervention. Methods: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the LEADERS trial (patients after surgical revascularization were excluded). Post hoc analysis was performed by stratifying clinical outcomes at 1-year follow-up, according to 1 of 3 SXscore tertiles. Results: The 1,397 patients were divided into tertiles based on the SXscore in the following fashion: SXscore ≤8 (SXlow) (n = 464), SXscore >8 and ≤16 (SXmid) (n = 472), and SXscore >16 (SXhigh) (n = 461). At 1-year follow-up, there was a significantly lower number of patients with major cardiac event-free survival in the highest tertile of SXscore (SXlow = 92.2%, SXmid = 91.1%, and SXhigh = 84.6%; p < 0.001). Death occurred in 1.5% of SXlow patients, 2.1% of SXmid patients, and 5.6% of SXhigh patients (hazard ratio [HR]: 1.97, 95% confidence interval [CI]: 1.29 to 3.01; p = 0.002). The myocardial infarction rate tended to be higher in the SXhigh group. Target vessel revascularization was 11.3% in the SXhigh group compared with 6.3% and 7.8% in the SXlow and SXmid groups, respectively (HR: 1.38, 95% CI: 1.1 to 1.75; p = 0.006). Composite of cardiac death, myocardial infarction, and clinically indicated target vessel revascularization was 7.8%, 8.9%, and 15.4% in the SXlow, SXmid, and SXhigh groups, respectively (HR: 1.47, 95% CI: 1.19 to 1.81; p < 0.001). Conclusions: The SXscore, when applied to an all-comers patient population treated with drug-eluting stents, may allow prospective risk stratification of patients undergoing percutaneous coronary intervention. (LEADERS Trial Limus Eluted From A Durable Versus ERodable Stent Coating; NCT00389220)

The SYNTAX score revisited: A reassessment of the SYNTAX score reproducibility (Article)

2010-05-01T00:00:00Z

Objectives: To reassess the reproducibility of the SYNTAX score. Background: The SYNTAX score appears to have an important role to play in the evaluation of patients with complex coronary artery disease undergoing revascularisation. However, the calculation of the SYNTAX score relies on the subjective assessment of lesions using coronary angiography, and therefore is subject to intra-and inter-observer variability. Methods: The SYNTAX score was calculated in 100 patients randomly selected from the SYNTAX trial, on two occasions 8 weeks apart, by a team made up of three interventional cardiologists. The weighted kappa values were compared with values obtained 1 year previously, when core lab analysts assessed the intra-observer reproducibility amongst the same patient cohort. Results: The mean ± standard deviation difference in SYNTAX score was 2.1 ± 7.6. The respective weighted kappa values for the number of lesions, bifurcation lesions, ostial lesions, and total occlusions were 0.62, 0.36, 0.66, and 0.91 compared with 0.59, 0.41, 0.63, and 0.82 in the previous core lab assessment. The weighted kappa for the intra-observer reproducibility of the SYNTAX score grouped into deciles was 0.54, and according to the terciles ≤22, >22-≤32, >32 was 0.51 both indicating a moderate level of agreement beyond the level of chance. In the previous assessment, the comparative kappa values were 0.45 and 0.53. Conclusions: The SYNTAX score has moderate intra-observer reproducibility when assessed by a team of three interventional cardiologists, which is consistent with a prior evaluation performed by core lab analysts. The scoring of bifurcation lesions remains the main source of inconsistency.

Clinical end points in coronary stent trials: A case for standardized definitions (Article)

2007-05-01T00:00:00Z

BACKGROUND - Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. METHODS AND RESULTS - The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. CONCLUSION - Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.

Cyphering the Complexity of Coronary Artery Disease Using the Syntax Score to Predict Clinical Outcome in Patients With Three-Vessel Lumen Obstruction Undergoing Percutaneous Coronary Intervention (Article)

2007-04-15T00:00:00Z

The Syntax score (SXscore) was recently developed as a comprehensive angiographic scoring system aiming to assist in patient selection and risk stratification of patients with extensive coronary artery disease undergoing contemporary revascularization. A validation of this angiographic classification scheme is lacking. We assessed its predictive value in patients who underwent percutaneous intervention (PCI) for 3-vessel disease and explored its performance in comparison with the modified lesion classification system of the American Heart Association/American College of Cardiology. The SXscore, applied to 1,292 lesions in 306 patients who underwent PCI for 3-vessel disease in the Arterial Revascularization Therapies Study Part II, was 4 to 54.5, and after a median of 370 days (range 274 to 400) predicted the rate of major adverse cardiac and cerebrovascular events (hazard ratio 1.08/U increase, 95% confidence interval 1.05 to 1.11, p <0.0001), with patients in the highest SXscore tertile having a significantly higher event rate (27.9%) than patients in the lowest tertile (8.7%, hazard ratio 3.5, 95% confidence interval 1.7 to 7.4, p = 0.001). By multivariable analyses, SXscore independently predicted outcome with an almost fourfold adjusted increase in the risk of major adverse cardiac and cerebrovascular events in patients with high versus low values based on the discrimination level provided by classification and regression tree analysis. Compared with the modified lesion classification scheme of the American Heart Association/American College of Cardiology, SXscore showed a greater discrimination ability (c-index 0.58 ± 0.08 vs 0.67 ± 0.08, respectively, p <0.001) and a better goodness of fit with the Hosmer-Lemeshow statistic. In conclusion, the SXscore is a promising tool to risk stratify outcome in patients with extensive coronary artery disease undergoing contemporary PCI.

The effect of completeness of revascularization on event-free survival at one year in the ARTS trial. (Article)

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.

Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial. (Article)

2001-05-10T00:00:00Z

OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.

Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease (Article)

2001-01-01T00:00:00Z

BACKGROUND: The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease. METHODS: A total of 1205 patients were randomly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year. The costs of hospital resources used were also determined. RESULTS: At one year, there was no significant difference between the two groups in terms of the rates of death, stroke, or myocardial infarction. Among patients who survived without a stroke or a myocardial infarction, 16.8 percent of those in the stenting group underwent a second revascularization, as compared with 3.5 percent of those in the surgery group. The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery (P<0.001 by the log-rank test). The costs for the initial procedure were $4,212 less for patients assigned to stenting than for those assigned to bypass surgery, but this difference was reduced during follow-up because of the increased need for repeated revascularization; after one year, the net difference in favor of stenting was estimated to be $2,973 per patient. CONCLUSION: As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.

Clinical and Angiographic Factors Associated With Asymptomatic Restenosis After Percutaneous Coronary Intervention (Article)

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.

Randomized comparison of primary stenting and provisional balloon angioplasty guided by flow velocity measurement. (Article)

2000-01-01T00:00:00Z

BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.

Does angiography six months after coronary intervention influence management and outcome? Benestent II Investigators. (Article)

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

Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group. (Article)

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.

Heparin-coated Palmaz-Schatz Stents in Human Coronary Arteries. . (Article)

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.

A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. (Article)

1994-01-01T00:00:00Z

BACKGROUND. Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty. METHODS. A total of 520 patients with stable angina and a single coronary-artery lesion were randomly assigned to either stent implantation (262 patients) or standard balloon angioplasty (258 patients). The primary clinical end points were death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for coronary-artery bypass surgery, or a second percutaneous intervention involving the previously treated lesion, either at the time of the initial procedure or during the subsequent seven months. The primary angiographic end point was the minimal luminal diameter at follow-up, as determined by quantitative coronary angiography. RESULTS. After exclusions, 52 patients in the stent group (20 percent) and 76 patients in the angioplasty group (30 percent) reached a primary clinical end point (relative risk, 0.68; 95 percent confidence interval, 0.50 to 0.92; P = 0.02). The difference in clinical-event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P = 0.005). The mean (+/- SD) minimal luminal diameters immediately after the procedure were 2.48 +/- 0.39 mm in the stent group and 2.05 +/- 0.33 mm in the angioplasty group; at follow-up, the diameters were 1.82 +/- 0.64 mm in the stent group and 1.73 +/- 0.55 mm in the angioplasty group (P = 0.09), which correspond to rates of restenosis (diameter of stenosis, > or = 50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P < 0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, P < 0.001). CONCLUSIONS. Over seven months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.

Quantitative angiographic follow-up of the coronary wallstent in native vessels and bypass grafts (European experience - March 1986 to March 1990) (Article)

1992-01-01T00:00:00Z

The coronary stent has been investigated as an adjunct to percutaneous transluminal coronary angioplasty to obviate the problems of early occlusion and late restenosis. From March 1986 to March 1990, 265 patients (308 lesions) were implanted with the coronary Wallstent in 6 European centers. For this study, the patients were analyzed according to date of implantation (group 1, March 1986 to January 1988; group 2, February 1988 to March 1990) and vessel type (native arteries versus bypass grafts). Quantitative angiographic follow-up was performed in 82% of the study patients. The early in-hospital occlusion rate in the overall group was 15%. Group 1 patients had a 20% rate in contrast to 12% rate in group 2 (p = not significant [NS]). The early occlusion rate in native vessels and bypass grafts was 19 and 8%, respectively (p = 0.019). Restenosis was determined by 2 criteria (criterion 1, greater than or equal to 0.72 mm loss in minimal luminal diameter from poststent to follow-up; criterion 2, greater than or equal to 50% diameter stenosis at follow-up) within the stent and in the segments immediately proximal and distal to the stent. The restenosis rate with criterion 1 was 43% in the overall group of patients, 35% in group 1 versus 49% in group 2 (p = NS), and 34% in native vessels versus 54% in bypass grafts (p = 0.016). The second criterion was met by 27% of patients in the overall group, 21% in group 1 versus 32% in group 2 (p = NS), and 18% in native vessel versus 39% in bypass grafts (p = 0.005).(ABSTRACT TRUNCATED AT 250 WORDS)