SMART: The MicroStent's ability to limit restenosis trial

In this randomized, prospective, multicenter trial (n = 661) of patients with de novo or restenotic coronary lesions, 330 patients received the MicroStent(R) II (MSII), and 331 received the Palmaz-Schatz(R) (PS) stent. The short-term procedural success rates were 94.4% and 95.7%, respectively (P = 0.47). The 30-day cumulative incidence of major adverse events [death, myocardial infarction, CVA, target lesion revascularization (TLR)] was 6.4% for the MSII and 4.5% for the PS stent (P = 0.31). The in-stent binary restenosis rate at 6 months was 25.2% for the MSII and 22.1% for the PS stent (P = 0.636). Using Kaplan-Meier estimates, the incidence of clinically driven TLR was 8.9% for the MSII and 9.2% for the PS stent at 180 days; at 270 days, it was 12.8% and 12.1%, respectively (P = 0.83). MSII and the PS stents were comparable with respect to short-term procedural success, complications, and late clinical and angiographic restenosis. (C) 2001 Wiley-Liss, Inc.