ABSTRACT
BACKGROUND: Restenosis after coronary interventions with stent implantation is still the main obstacle of interventional cardiology. The aim of this study was to compare a carbonized and high-grade stainless steel stent of identical design with regard to early and late adverse events. METHODS: In this prospective randomized trial the carbonized MAC stent (amg GmbH, Raesfeld-Erle, Germany) was compared with the stainless steel MAC stent of identical design. Primary end point was diameter stenosis at follow-up; secondary end points were angiographic parameters, rate of restenosis, and major cardiac adverse events (MACE; myocardial infarction, reintervention, and death). RESULTS: Between August 1999 and June 2002, 396 patients were randomized in 2 centers of Germany. Diameter stenosis at follow-up (38.6% +/- 23.4% vs 39.1% +/- 22.2%, P = .49) as primary end point, relative late lumen loss (26.8% +/- 23.7% vs 27.7% +/- 22.3%, P = .26), absolute late lumen loss (0.92 +/- 0.71 vs 0.92 +/- 0.66 mm, P = .58), net gain (1.4 +/- 0.8 vs 1.4 +/- 0.8 mm, P = .96), as well as restenosis rates (18.0% vs 19.0%, P = .81) and MACE (13.5% vs 12.2%, P = .71) were not significantly different between the carbonized and the pure stainless steel study arm, respectively. CONCLUSION: The hypothesis of superiority of the carbonized stent over a stainless steel stent of identical design with regard to restenosis and MACE could not be proved. Inactive coating of stents seems to have no advantage over pure stainless steel stents, which was also demonstrated in other trials. The future probably lies in active coating of stents with drugs that reduce the neointimal proliferation process.
