Abstract 2163: Long-term Follow-up (>3 Years) of Patients Treated With Sirolimus-Eluting Stents for In-stent Restenosis. Results of a Randomized Study.

Background: The value of drug-eluting stents in patients (P) with in-stent restenosis (ISR) has been established. However, the long-term results of this strategy in P with ISR remains unknown. Objective: We sought to determine the long-term clinical outcome of P treated with sirolimus-eluting stents (SES) for ISR. Methods: A systematic, pre-specified, long-term clinical follow-up (FU) was performed in all P included in the RIBS II (Restenosis Intra-stent: Balloon angioplasty [BA] vs elective SES implantation) randomized trial. In RIBS II 150 P with ISR after bare-metal stent implantation were included: 74 allocated to BA and 76 to SES. Late angiography was obtained in 96% of eligible P. A structured clinical questionnaire (cardiac/non cardiac death, myocardial infarction [MI], target vessel revascularization [TVR], thrombosis [TH], and medical therapy) was used during FU. Results: Angiographic restenosis (primary end-point) was more frequently found in the BA arm (39% vs 11%, p<0.001). Clinical FU at 1-year was obtained in 150 P (100%). During this time period 6 P died (3 SES, 3 BA), 4 P suffered a MI (2 SES, 2 BA), 2 P experienced TH (1 P in each arm) and 30 required TVR (8 SES, 22 BA, p<0.01). A complete clinical FU >3 years was obtained in 145 P (97%) (mean 38±9 months, median 40 months [IQR 37–42]). Late events (after 1 year, non-exclusive) included: 3 deaths (1 SES, 2 BA), 3 MI (3 SES, 2 due to late TH) and 7 late TVR (5 SES, 2 BA). At 4 years, event-free survival was 76% in the SES arm and 65% in the BA arm (p=0.03). Survival free from TVR at 4 years was 80% in the SES arm and 67% in the BA arm (p=0.02). Conclusion: In P with ISR SES implantation improve the long-term clinical outcome as compared with BA treatment.