Original Studies Long-Term Clinical Outcomes After Sirolimus-Eluting Stent Implantation for Treatment of Restenosis Within Bare-Metal Versus Drug-Eluting Stents

Background: Sirolimus-eluting stents have been increasingly used for treatment of restenosis after implantation of bare metal stents (BMSs) or drug-eluting stents (DESs), but little is known regarding their long-term outcomes. Methods: We compared longterm clinical outcomes in 295 patients treated with sirolimus-eluting stents for postBMS (n 5 224) vs. post-DES (n 5 71) restenosis. All follow-ups were at least 12 months, and the primary endpoint was major adverse cardiac events (MACE), defined as cardiac death, nonfatal myocardial infarction (MI) or target lesion revascularization (TLR). Results: Baseline characteristics were similar between the two groups, except that mean lesion length (28.0 6 16.2 vs. 19.5 6 13.6, P < 0.01) and mean stented length (35.4 6 19.2 vs. 25.7 6 14.7, P < 0.01) were significantly longer in the post-BMS group. Major in-hospital complications occurred in 2 patients. During a mean follow-up of 31.3 6 11.1 months, there were 9 deaths (4 cardiac, 5 noncardiac), 3 nonfatal MIs, and 25 TLRs. Late stent thrombosis was documented in 2 patients (1 in each group). There were no between group differences in cardiac or total deaths, but there were trends toward less frequent cardiac death/MI or TLR in the post-BMS group. The cumulative probability of MACE-free survival was significantly better for the post-BMS group (95.0% 6 1.5% vs. 87.3% 6 4.0% at 1 year; 93.0% 6 1.7% vs. 81.0% 6 5.2% at 2 years; Log Rank P 5 0.016). In multivariate analysis, post-DES restenosis was the only significant predictor of MACE (OR 3.29, 95%CI 1.13–9.61, P 5 0.029). Conclusions: Sirolimus-eluting stents were effective for treatment of in-stent restenosis, but post-DES restenosis was associated with poorer outcomes than post-BMS restenosis. ' 2008 Wiley-Liss, Inc.