Randomized comparison of J&J Crown stent versus NIR stent after routine coronary angioplasty.

BACKGROUND Coronary artery stents are used for the treatment of acute or threatening vessel occlusion complicating coronary angioplasty or for prevention of restenosis after angioplasty. The current randomized trial compared the procedural outcome and long-term patency of 2 different flexible stents in unselected lesion morphology. METHODS The study population consisted of consecutive patients undergoing coronary angioplasty for symptomatic coronary artery disease followed by high-pressure stent implantation. The poststent treatment consisted of antiplatelet therapy. The primary hypothesis was an assumed restenosis rate of 30% in the group receiving NIR stents (Boston Scientific Europe SPRL, Parc Industriel de Petit-Rechain, Belgium) and a reduction of the restenosis rate (defined as >50% vessel diameter at follow-up) by 50% in the group undergoing J&J Crown stent (Cordis, Johnson & Johnson Interventional Systems, Warren, NJ) implantation: the restenosis rate and minimal luminal diameter at follow-up. Follow-up angiography was performed 6 months after the initial procedure. RESULTS A total of 203 patients were randomized to receive either the J&J Crown stent (n = 103) or the NIR stent (n = 100). The procedural success was similar in both groups (96.1% vs 99% in the NIR stent group, respectively; P =.19). There were 4 cases of crossover from the J&J Crown to the NIR stent group. In one patient, stent implantation of either stent model did not succeed. One patient died from fulminant pulmonary embolism. Restenosis, defined as >50% diameter stenosis at follow-up 5.8 +/- 1.3 months after the initial procedure occurred in 19 patients (18.4%) in the J&J Crown stent group compared with 22 patients (22.0%) in the NIR stent group (P =.42). There was a significantly higher rate of crossover from the J&J Crown stent to the NIR stent (3.9% vs 0%, respectively, P =.047), whereas reverse crossover did not occur. The one lesion in which NIR stent implantation was not successful had an extremely tortuous proximal part. This patient underwent only balloon angioplasty. Clinical events were rare during 6 months of follow-up and the incidence did not differ between both groups (nonfatal myocardial infarction: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32; all-cause mortality: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32). CONCLUSIONS There were no significant angiographic and clinical differences between the J&J Crown and NIR stents. Both stents had a similar procedural success rate, although the implantation of NIR stents was successful even in vessels in which previous attempts at J&J Crown stent placement had failed.