Abstract 3252: Sirolimus-Eluting Stents Versus Bare-Metal Stents in Patients with In-Stent Restenosis. Pooled Results from Two Randomized Studies.
We sought to compare results of sirolimus-eluting stents (SES) with those of bare-metal stents (BMS) in patients (P) with in-stent restenosis (ISR). Accordingly, the results obtained in the stent arm of two randomized studies were analyzed. The RIBS I study (Restenosis Intra-stent: balloon angioplasty [BA] vs BMS) included 450 P with ISR, 226 allocated to BA and 224 to BMS. The RIBS II study (Restenosis Intra-stent: BA vs SES) included 150 P with ISR, 74 allocated to BA and 76 to SES. Systematic late angiography was obtained in 95% and 96% of eligible P. Complete 1-year clinical follow-up was obtained in all cases (600 P, 100%). Although inclusion/exclusion criteria were similar in the two studies, P included in RIBS II had more adverse baseline characteristics including older age (64±11 vs 61±11 years, p<0.05 ), higher frequency of diabetes (35% vs 26%, p<0.05), previous myocardial infarction (55% vs 43%, p<0.05), diffuse ISR (73% vs 60%,p<0.05), and by QCA longer lesions (16±9 vs 13±7 mm, p<0.001) and smaller vessels (2.67±0.5 vs 2.85±0.5 mm, p<0.001). Results immediately after the procedure were similar in P treated with BMS and SES. However, late angiographic findings including recurrent restenosis rate (11% vs 38%, p<0.001), minimal lumen diameter (2.40±0.7 vs 1.63±0.8 mm, p<0.001 ), and late loss (0.28±0.6 [median 0.13] vs 1.12±0.8 mm, p<0.001) were significantly better after SES. In addition, the 1-year event-free survival (freedom from death, myocardial infarction and target vessel revascularization [TVR]) was significantly improved in the SES group (88% vs 77%, p<0.05), mainly as the result of a lower requirement for TVR after SES (11% vs 19.6%, p<0.05). In conclusion, as compared with BMS, SES improve the long-term clinical and angiographic outcome of patients with ISR.