Comparison of early and late results of a Carbofilm-coated stent versus a pure high-grade stainless steel stent (the Carbostent-Trial).

The long-term success of coronary interventions with stents is largely determined by the development of restenosis. 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. 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 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). From March 2000 to June 2002 at 18 centers in Canada and Europe, 420 patients were randomized. Relative late luminal loss (Carbofilm 28.9 +/- 23.0% vs stainless steel 26.7 +/- 20.2%, p = 0.95) as the primary end point, absolute late luminal loss (1.00 +/- 0.72 vs 0.93 +/- 0.62 mm, p = 0.95), net gain (1.32 +/- 0.82 vs 1.40 +/- 0.74 mm, p = 0.75), and the degree of stenosis (40.7 +/- 22.9% vs 38.0 +/- 20.1%, p = 0.92), as well as restenosis rates (23.5% vs 15.9%, p = 0.09) and MACEs (20.1% vs 13.7%, p = 0.11) were not significantly different. Thus, the Carbofilm coating of stents does not lead to an improvement in angiographic results or a reduction of restenosis rate and MACEs. These results agree with other trials using inactive coatings on stents, which also could not demonstrate any advantage over pure stainless steel stents.