Randomized Comparison of GR-II Stent and Palmaz-Schatz Stent for Elective Treatment of Coronary Stenoses

Abstract

Background —This prospective multicenter randomized clinical trial was designed to evaluate the long-term angiographic and clinical outcomes of elective treatment with the GR-II stent compared with the Palmaz-Schatz (PS) stent in patients with coronary stenoses. Methods and Results —Seven hundred fifty-five patients with myocardial ischemia and de novo native coronary stenoses in 3- to 4-mm vessels were randomly assigned to the PS (375 patients) or the GR-II stent (380 patients). The primary end point was 12-month target lesion revascularization (TLR)-free survival. Angiography was performed at baseline and at follow-up in the first 300 consecutive patients to assess the frequency of angiographic restenosis. Procedure success was 98.5% for the GR-II stent and 99.4% for the PS stent ( P =0.19). At 30 days, patients assigned to the GR-II stent had a higher stent thrombosis rate (3.9% versus 0.3% for PS stent, P <0.001) and TLR rate (3.9% versus 0.5% for PS stent, P <0.001). The GR-II group had a higher follow-up restenosis frequency (47.3% versus 20.6% for the PS group, P <0.001) and a lower 12-month TLR-free survival rate (71.7% versus 83.9% for the PS group, P <0.001). Multivariate logistic regression analysis identified a smaller final stent minimal lumen diameter (odds ratio [OR] 2.49, 95% CI 1.56 to 3.98; P <0.001), diabetes mellitus (OR 2.14, 95% CI 1.42 to 3.22; P <0.001), and use of the GR-II stent (OR 1.78, 95% CI 1.20 to 2.64; P <0.01) as independent determinants of 12-month TLR. Conclusions —On the basis of these long-term follow-up data, we conclude that use of the GR-II stent should be limited to the acute treatment of abrupt or threatened closure after failed conventional balloon angioplasty procedures.