The French Randomized Optimal Stenting Trial: A prospective evaluation of provisional stenting guided by coronary velocity reserve and quantitative coronary angiography

OBJECTIVES We sought to make a prospective comparison of systematic stentin g with provisional stenting guided by Doppler measurements of coronary velo city reserve and quantitative coronary angiography. BACKGROUND Despite the increasing use of stents during percutaneous translu minal coronary angioplasty, it is unclear whether systematic stenting is su perior to a strategy of provisional stenting in which stents are placed onl y in patients with unsatisfactory results or as a hail-out procedure. METHODS Two hundred fifty-one patients undergoing elective coronary angiopl asty were randomly assigned either to provisional stenting (group 1, in whi ch stenting was performed if postangioplasty coronary velocity reserve was <2.2 and/or residual stenosis greater than or equal to 35% or as hail-out) or to systematic stenting (group 2). The primary end point was the six-mont h angiographic minimal lumen diameter (MLD). Major adverse cardiac events w ere secondary end points (death, acute myocardial infarction and target les ion revascularization), RESULTS Stenting was performed in 48.4% of patients in group 1 and 100% of patients in group 2 (p < 0.01). Six months after angioplasty, the MLD did n ot differ between groups (1.90 +/- 0.79 mm vs. 1.99 +/- 0.70 mm, p = 0.39), as was the rate of binary restenosis (27.1% vs. 21.4%, p = 0.37). Among pa tients with restenosis, 13/32 (40.6%) in group 1 but 100% (25/25) in group 2 had in-stent restenosis (p < 0.01). Target lesion revascularization (15.1 % vs. 14.4% in groups 1 and 2 respectively, p = 0.89) and major adverse car diac events (15.1% vs. 16.0%, p 0.85) were not significantly different. CONCLUSIONS Systematic stenting does not provide superior angiographic resu lts at six months as compared with provisional stenting. (C) 2000 by the Am erican College of Cardiology.