Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts

Objectives We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents; (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial. Background We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES. Methods A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization. Results Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (Interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29 % [95 % confidence interval (CI) 17 % to 45 %]) versus 0 after BMS (0 % [95 % CI 0 % to 9 %]) with an absolute difference of 29 % ([95 % CI 14 % to 45 %], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18 % and 34 % after SES, respectively, versus 5 % and 38 % after BMS, respectively (p = 0.15 and p = 0.74, respectively). Conclusions In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).