(Circulation. 2000;102:1364.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Comparison of GR-II Stent and Palmaz-Schatz Stent for Elective Treatment of Coronary Stenoses
From Lenox Hill Hospital (A.J.L., G.S.R., R.M., M.B.L.), New York, NY; the North Ohio Heart Center (C.D.O.), Elyria; Baptist Medical Center (P.B.M.), Montgomery, Ala; the University of Alabama at Birmingham (L.S.D.); Methodist Hospital (A.E.R.), Houston, Tex; William Beaumont Hospital (R.D.S.), Royal Oak, Mich; Duke Medical Center (J.P.Z.), Durham, NC; Brigham and Women’s Hospital (J.J.P.) and Beth Israel Deaconess Hospital (R.E.K.), Boston, Mass; and MED Institute (J.L.K.), West Lafayette, Ind.
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.
Key Words: angioplasty • stents • restenosis
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