BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

*Stents, *Time, Coronary Restenosis/pathology, Coronary Stenosis/*surgery, Coronary Vessels/*pathology, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle aged, Myocardial Revascularization, Sirolimus/*metabolism
dx.doi.org/10.1161/01.CIR.0000156334.24955.B2, hdl.handle.net/1765/13703
Circulation (Baltimore)
Epub 2005 Feb 21
Erasmus MC: University Medical Center Rotterdam

Fajadet, J, Morice, M-C, Barragan, P, Serruys, P.W.J.C, Wijns, W, Constantini, C, … Wülfert, E. (2005). Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation (Baltimore), 111(8), 1040–1044. doi:10.1161/01.CIR.0000156334.24955.B2