Randomized comparison of the coil-design Crossflex and the tubular NIR stent.

The purpose of this study was to compare the angiographic outcome of implantation of the coil-design Crossflex stent with the tubular NIR stent for treatment of coronary artery stenoses. Two hundred twenty-three patients with one genuine coronary artery lesion were randomized to implantation with a 15 mm Crossflex stent (n = 112) or a 16 mm NIR stent (n = 111). The patients had angiographic follow-up after 6 months. Primary endpoint was minimal luminal diameter (MLD) after 6 months. There was a similar clinical outcome in the two groups. At 6-month follow-up, the MLD was significantly lower in the Crossflex group (1.94 +/- 0.79 mm) than in the NIR group (2.37 +/- 0.84 mm; P < 0.001). Early gain was the same in the two groups. Late loss and percent diameter stenoses were significantly higher in the Crossflex group. The binary restenoses rate was 26% and 17% in the Crossflex and the NIR groups, respectively (P = NS). The coil-design Crossflex stent was found to be inferior to the tubular NIR stent concerning late loss and MLD at 6-month follow-up. Copyright 2003 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes