Objectives: We sought to compare, in a randomized fashion, sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVGs). Background: Sirolimus-eluting stents reduce restenosis and repeated revascularization in native coronary arteries compared with BMS. However, randomized data in SVG are absent. Methods: Patients with SVG lesions were randomized to SES or BMS. All were scheduled to undergo 6-month coronary angiography. The primary end point was 6-month angiographic in-stent late lumen loss. Secondary end points included binary angiographic restenosis, neointimal volume by intravascular ultrasound and major adverse clinical events (death, myocardial infarction, target lesion, and vessel revascularization). Results: A total of 75 patients with 96 lesions localized in 80 diseased SVGs were included: 38 patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. In-stent late loss was significantly reduced in SES (0.38 ± 0.51 mm vs. 0.79 ± 0.66 mm in BMS, p = 0.001). Binary in-stent and in-segment restenosis were reduced, 11.3% versus 30.6% (relative risk [RR] 0.37; 95% confidence interval [CI] 0.15 to 0.97, p = 0.024) and 13.6% versus 32.6% (RR 0.42; 95% CI 0.18 to 0.97, p = 0.031), respectively. Median neointimal volume was 1 mm3 (interquartile range 0 to 13) in SES versus 24 (interquartile range 8 to 34) in BMS (p < 0.001). Target lesion and vessel revascularization rates were significantly reduced, 5.3% versus 21.6% (RR 0.24; 95% CI 0.05 to 1.0, p = 0.047) and 5.3% versus 27% (RR 0.19; 95% CI 0.05 to 0.83, p = 0.012), respectively. Death and myocardial infarction rates were not different. Conclusions: Sirolimus-eluting stents significantly reduce late loss in SVG as opposed to BMS. This is associated with a reduction in restenosis rate and repeated target lesion and vessel revascularization procedures. (The RRISC Study; http://clinicaltrials.gov/ct/show; NCT00263263).

doi.org/10.1016/j.jacc.2006.09.021, hdl.handle.net/1765/54072
Journal of the American College of Cardiology
Department of Cardiology

Vermeersch, P., Agostoni, P., Verheye, S., van den Heuvel, P., Convens, C., Bruining, N., … van Langenhove, G. (2006). Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Diseased Saphenous Vein Grafts. Six-Month Angiographic, Intravascular Ultrasound, and Clinical Follow-Up of the RRISC Trial. Journal of the American College of Cardiology, 48(12), 2423–2431. doi:10.1016/j.jacc.2006.09.021