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 long-term clinical outcomes in 295 patients treated with sirolimus-eluting stents for post-BMS (n = 224) vs. post-DES (n = 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 +/- 16.2 vs. 19.5 +/- 13.6, P < 0.01) and mean stented length (35.4 +/- 19.2 vs. 25.7 +/- 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 +/- 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% +/- 1.5% vs. 87.3% +/- 4.0% at 1 year; 93.0% +/- 1.7% vs. 81.0% +/- 5.2% at 2 years; Log Rank P = 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 = 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.