SIRIUS trial

Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PI, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation. 2004 Feb 10 109(5) 634-40. 

Weisz, G., Leon, M.B., Holmes, D.R., et al. Two-year outcomes after sirolimus-Eluting stent implantation results from the sirolimus-Eluting in de Novo Native Coronary Lesions (SIRIUS) trial. J. Am. Coll. Cardiol. 47, 1350-1355 (2006)... 

Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries. Double-blind, randomized controlled trial. (E-SIRIUS). Lancet 2003 362 1093-1099. 

The first clinical study was the RAVEL trial, which showed that no cases of restenosis were observed with the DES, but 26.6% of BMS cases suffered from restenosis [31]. A 3 year follow-up of the RAVEL study showed sustained clinical benefits [35], during which another set of trials called the SIRIUS study compared the safety and efficacy of the sirolimus eluting stent with two smaller studies that were performed in Europe (E-SIRIUS) and Canada (C-SIRIUS) [36-39]. The combined results showed a reduction in in-stent restenosis from 38.5% (BMS) to 3.1% (sirolimus eluting stent). 

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