Long-term efficacy and safety of sirolimus-eluting vs bare-metal stents

Raymond G. McKay, Deborah J. Murphy, Jill Cloutier, Jeffrey F. Mather, Roger A. Mennett, Marcin R. Dada, Anuj R. Shah, Francis J. Kiernan

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Although previous studies have documented persistent clinical benefit of sirolimus-eluting stents (SES) in reducing the need for target vessel revascularization without an increase in myocardial infarction (MI) or mortality, the long-terni safety and efficacy of CYPHER stent use in routine clinical practice, including off-label stent implantation, remains uncertain. Methods: We compared long-term clinical outcomes in 2,550 patients treated with one or more SES with 1,022 patients treated with one or more bare metal or heparin-coated stents (BMS). The study groups included 1,058 SES patients (41.5%) and 488 BMS patients (47.7%) with off-label indications. A propensity-score method was utilized to adjust for differences in baseline characteristics. Patients were followed for up to five years for the occurrence of all-cause mortality, MI and repeat target vessel revascularization. Results: Compared to BMS patients, SES patients demonstrated significantly improved event-free survival with respect to all-cause mortality (RR, 1.39; 95% CI, 1.07 to 1.80, P=0.014) and repeat target vessel revascularization (RR, 2.72; 95% CI, 1.99 to 3.73, P<0.001), with no significant difference in the incidence of cumulative MI. A landmark analysis, examining composite adverse events occurring six months after stent implantation in the two study groups, demonstrated no increased late hazard associated with SES use (relative risk, 1.08; 95% CI, 0.80 to 1.46). Conclusions: Use of SES in routine clinical practice, including off-label indications, is associated with improved long-term mortality, reduced need for repeat target vessel revascularization and no increase in MI compared to BMS.

Original languageEnglish
Pages (from-to)453-463
Number of pages11
JournalConnecticut Medicine
Volume72
Issue number8
StatePublished - Sep 2008
Externally publishedYes

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