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Five-Year Cumulative Rates of Clinical Events after Cypher™ Stent Implantation

This study presents the 5-year safety and efficacy outcomes of sirolimus-eluting stents (SES) compared to bare metal stents (BMS) in four randomized trials. The results show no significant differences in the rates of death, myocardial infarction (MI), or stent thrombosis between the two groups at 5 years. However, in patients with diabetes, treatment with SES was associated with a higher incidence of death. There was a significantly lower rate of target vessel revascularization (TVR) in patients treated with SES.

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Five-Year Cumulative Rates of Clinical Events after Cypher™ Stent Implantation

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  1. Five-Year Cumulative Rates of Clinical Events after Cypher™ Stent Implantation:Insights from a Patient-Level Pooled Analysis of Four Randomized Trials Comparing Sirolimus-Eluting Stents with Bare Metal Stents Adriano Caixeta, Roxana Mehran, Jeffrey W. Moses, George Dangas, Helen Parise, Ajay Kirtane, David R. Holmes, Charles O’Shaughnessy, Dennis Donohoe, Ronald Caputo, Dean J. Kereiakes, David O’ Williams, Martin B. Leon

  2. Disclosure Statement of Financial Interest I, Adriano Caixeta DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  3. Background Sirolimus-eluting stents (SES) were approved for clinical use in 2003 to dramatically reduce the incidence of restenosis and rates of target lesion revascularization (TLR). Delayed arterial healing response after drug-eluting stent (DES) implantation has raised concerns about the long-term safety of DES. Although 4-year clinical outcomes in a pooled analysis of data from the four double-blind SES vs. bare metal stent (BMS) trials has been published recently*, 5-year clinical follow-up was scheduled by protocols in the four pivotal Cypher™ sirolimus-eluting stent (SES) and bare metal stent (BMS) randomized trial. *Spaulding C, et al, N Engl J Med 2007;356:989-997.

  4. Purpose • The aim of this study was to evaluate the 5-year safety and efficacy of SES compared with BMS. • The primary safety endpoint was death or myocardial infarction (MI). The secondary safety endpoint was stent thrombosis adjudicated according to the Academic Research Consortium (ARC) definition. • The primary efficacy endpoint was target vessel revascularization (TVR) up to 5 years.

  5. Methods Patient-level Pooled Analysis RAVEL1 (N=238) SIRIUS2 (N=1058) E-SIRIUS3 (N=352) C-SIRIUS4 (N=100) August 2000 and April 2002 1,748 patients at 115 international centers • De novo • 15 to 32 mm long • RD 2.5 to 3.5 mm • Aspirin 81 to 325 mg • Clopidogrel 75 mg 2-3 mo Cypher™ Sirolimus-eluting stent (N=878) BX Velocity Bare metal stent (N=870) 1Morice MC,et al, N Engl J Med 2002;346:1773-80. 2Moses JW, et al, N Engl J Med 2003;349:1315-23. 3Schofer J, et al, Lancet 2003;362:1093-9. 4Schampaert E, et al, J Am Coll Cardiol 2004;43:1110-5.

  6. Results Baseline Characteristics I

  7. Results Procedure Characteristics

  8. All Cause Mortality 8.9% P=0.57 8.2%

  9. Cardiac Death P=0.55 4.4% 3.9%

  10. Death and MI 15.1% P=0.36 13.6%

  11. Definite/Probable Stent Thrombosis(ARC defined) P=0.99 2.0% 2.1%

  12. Target Lesion Revascularization 24.7% P<0.01 9.6%

  13. Target Vessel Revascularization 30.1% P<0.01 15.2%

  14. Results Annualized Hazard Ratio per 100 pt-years

  15. Diabetic Subgroup: Death P=0.03 16.1% 9.9%

  16. Diabetic Subgroup: Death or MI P=0.25 20.9% 17.4%

  17. Conclusions In a patient-level pooled analysis of the four SES and BMS randomized trials, no significant differences in the rates of death, MI, death/MI were observed at 5 years. In pts with diabetes, however, treatment with SES was associated with a statistically higher incidence of death at 5 years. No significant differences in the rates of any ARC-defined stent thrombosis were observed between SES and BMS at 5 years. A significant difference in TVR rate was observed in favor of pts treated with SES at 5 years.

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