Long-Term Clinical Benefit of Sirolimus-Eluting Stents in Patients With In-Stent Restenosis Results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) Study

Objectives We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with instent restenosis (ISR). Background Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown. Methods The RIBS-II ( Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR ( 76 SES, 74 balloon angioplasty [ BA]). The long-term ( > 1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points. Results At 1 year, the event-free survival ( death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term ( > 3 years) clinical follow-up was obtained in 97% of patients ( median 3.3 years). After the first year, 3 patients died ( 1 SES, 2 BA), 5 suffered myocardial infarction ( 4 SES, 1 BA), and 7 required TVR ( 4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm ( p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure. Conclusions In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up. (J Am Coll Cardiol 2008; 52: 1621-7) (c) 2008 by the American College of Cardiology Foundation