Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trial.

Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
Circulation (Impact Factor: 14.95). 06/2011; 123(24):2819-28, 6 p following 2828. DOI: 10.1161/CIRCULATIONAHA.110.004762
Source: PubMed

ABSTRACT Long-term comparative data of first-generation drug-eluting stents are scarce. We investigated clinical and angiographic outcomes of sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) at 5 years as part of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) LATE study.
A total of 1012 patients were randomly assigned to SES or PES. Repeat angiography was completed in 444 of 1012 patients (43.8%) at 5 years. Major adverse cardiac events occurred in 19.7% of SES- and 21.4% of PES-treated patients (hazard ratio, 0.89; 95% confidence interval, 0.68 to 1.17; P=0.39) at 5 years. There were no differences between SES and PES in terms of cardiac death (5.8% versus 5.7%; P=0.35), myocardial infarction (6.6% versus 6.9%; P=0.51), and target lesion revascularization (13.1% versus 15.1%; P=0.29). Between 1 and 5 years, the annual rate of target lesion revascularization was 2.0% (95% confidence interval, 1.4% to 2.6%) for SES and 1.4% (95% confidence interval, 0.9% to 2.0%) for PES. Among patients undergoing paired angiography at 8 months and 5 years, delayed lumen loss amounted to 0.37 ± 0.73 mm for SES and 0.29 ± 0.59 mm for PES (P=0.32). The overall rate of definite stent thrombosis was 4.6% for SES and 4.1% for PES (P=0.74), and very late definite stent thrombosis occurred at an annual rate of 0.65% (95% confidence interval, 0.40% to 0.90%).
Long-term follow-up of first-generation drug-eluting stents shows no significant differences in clinical and angiographic outcomes between SES and PES. The continuous increase in late lumen loss in conjunction with the ongoing risk of very late stent thrombosis suggests that vascular healing remains incomplete up to 5 years after implantation of first-generation drug-eluting stents.

  • The Lancet 03/2014; · 39.21 Impact Factor
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    ABSTRACT: Abstract Objective. Millions of patients were treated with the sirolimus-eluting Cypher™ and the paclitaxel-eluting Taxus™ coronary stents with potential late occurring increase in event rates. Therefore, the long-term outcome follow up is of major clinical interest. Design. In total, 2.098 unselected patients with ST-segment elevation myocardial infarction (STEMI), non-STEMI, stable or unstable angina pectoris were randomized to receive Cypher™ (n = 1.065) or Taxus™ (n = 1.033) stents and were followed for 5 years. Results. The primary end-point; the composite of cardiac death, myocardial infarction and target vessel revascularization (MACE), occurred in 467 patients (22.3%); Cypher™ n=222 (20.8%), Taxus™ n=245 (23.7%), ns. Definite and probable stent thrombosis occurred in 107 patients (5.1%); Cypher™ n=51 (4.8%), Taxus™ n=56 (5.4%), ns. There were no statistically significant differences in the elements of the primary endpoint or in other secondary endpoints between the two stent groups. After one year, the yearly rates of stent thrombosis and MACE remained constant. Conclusions. During five year follow up, the Cypher™ and the Taxus™ coronary stents had similar clinic outcome with no signs of increasing rates of adverse events over time.
    Scandinavian cardiovascular journal: SCJ 02/2014; · 1.07 Impact Factor
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    ABSTRACT: Background Previous research has shown that African-Americans, patients without insurance, and those with government-sponsored insurance are less likely to be referred for invasive cardiovascular procedures. We therefore sought to compare the impact of race and insurance type upon the use of drug-eluting stents (DES). Methods Patients undergoing percutaneous coronary intervention (PCI) with stenting from January 2008 to December 2012 at Los Angeles County Hospital and Keck Hospital of USC were retrospectively analyzed. Race was categorized as African-American, Hispanic, or non-African-American/non-Hispanic. Insurance was categorized as private, Medicare, Medicaid, incarcerated, or uninsured. Multivariable logistic regression was performed, with receipt of ≥ 1 DES the outcome variable of interest. Results Among 2763 patients undergoing PCI, 62.8% received ≥ 1 DES, 45.4% were Hispanic, 6.7% were African-American, 33.2% were uninsured, 28.5% had Medicaid, 22.5% had Medicare, 14.1% had private insurance, and 1.7% were incarcerated. Following multivariable adjustment, African-Americans, in comparison to non-African-American/non-Hispanic patients, were less likely to receive ≥ 1 DES (odds ratio [OR] 0.57, 95% confidence interval [CI] 0.40-0.82, p = 0.002). Hispanic patients, however, were not less likely to receive DES. Uninsured patients (OR 1.51, 95% CI 1.13-2.03, p = 0.006) and those with Medicaid (OR 1.49, 95% CI 1.11-2.00, p = 0.008) were more likely to receive DES than patients with private insurance, whereas those with Medicare were less likely to receive DES (OR 0.71, 95% CI 0.52-0.95, p = 0.02). Conclusions African-American race continues to have a significant impact upon the decision to use DES. Future research should focus upon patient and provider perceptions at the time of PCI. Summary This study is a retrospective analysis of the impact of race and insurance status upon the utilization of drug-eluting stents. Multivariable logistic regression showed that African-American race was associated with less utilization of drug-eluting stents.
    Cardiovascular revascularization medicine: including molecular interventions 06/2014;