Abstract 5987: Long-Term Efficacy and Safety of Sirolimus-Eluting Versus Bare-Metal Stents for On- and Off-Label Indications
BACKGROUND: Although previous data suggest persistent clinical benefit of sirolimus-eluting stents (SES) in reducing target vessel revascularization without an increase in myocardial infarction (MI), cumulative stent thrombosis and mortality, the long-term safety and efficacy of CYPHER stent use in routine clinical practice, including off-label stent implantation, remains uncertain.
METHODS: We examined clinical characteristics, angiographic findings, in hospital and long-term clinical outcomes in 3572 patients of whom 2,550 were treated with SES, and 1,022 who were treated with 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, including acute MI, multivessel percutaneous coronary intervention, saphenous vein grafts and complex lesion morphology. A propensity-score method was utilized to adjust for differences in baseline characteristics. Patients were followed for up to 5 years for the occurrence of all-cause mortality, MI and repeat target vessel revascularization.
RESULTS: Compared to the BMS patients, the SES group 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) during the follow-up period, with no significant difference in the incidence of 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.