From March 2000 to June 2002 at 18 centers in Canada and Europe, 420 patients were randomized. The primary end point was relative late luminal loss, and secondary end points were diameter stenosis at 6 months, rate of restenosis, and major adverse cardiac events (MACEs) (myocardial infarction, reintervention, and death). In this prospective, randomized trial, the Carbofilm-coated Carbostent and Sirius stent (same stent design, newly developed delivery system) were compared with the stainless steel stents S660, S670, and S7 (newly developed delivery system, same principal stent design with a few changes). The aim of this study was to compare a Carbofilm-coated and a pure stainless steel stent with regard to early and late adverse events.

The long-term success of coronary interventions with stents is largely determined by the development of restenosis.