Context: Compared with bare metal stents, drug-eluting stents reduce restenosis in noncomplex lesions. The utility of drug-eluting stents has not been evaluated in more difficult stenoses. Objective: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in a patient population with more complex lesions than previously studied. Design, Setting,and Patients: Prospective, placebo-controlled, double-blind, multicenter randomized trial conducted from February 2003 to March 2004 at 66 academic and community based institutions with 1156 patients who underwent stent implantation in a single coronary artery stenosis(vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients(57.4% ) with complex or previously unstudied lesions(requiring 2.25-mm, 4.0-mm, and/or multiple stents) and 9-month clinical and angiographic follow-up. Interventions: Patients were randomly assigned to receive 1 or more bare metal stents(n=579) or identical-appearing paclitaxel-eluting stents(n=577).Main Outcome Measure: Ischemia-driven target vessel revascularization at 9 months. Results: Baseline characteristics were well matched. Diabetes was present in 31% of patients. The mean(SD) reference vessel diameter was 2.69(0.57) mm, the reference lesion length was 17.2(9.2) mm, and 78% of lesions were type B2/C. A mean(SD) of 1.38(0.58) stents(total mean SD length, 28.4 13.1 mm) were implanted per lesion; 33% of lesions required multiple stents. Stents that were 2.25 mm and 4.0 mm in diameter were used in 18% and 17% of lesions, respectively. Compared with bare metal stents, paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7% to 8.6% (P< .001) and target vessel revascularization from 17.3% to 12.1% (P=.02). Similar rates were observed for cardiac death or myocardial infarction(5.5% for bare metal stent group vs 5.7% for paclitaxel-eluting stent group) and stent thrombosis(0.7% in both groups). Angiographic restenosis was reduced from 33.9% to 18.9% in the entire study cohort(P< .001), including among patients receiving 2.25-mm stents(49.4% vs 31.2% ; P=.01), 4.0-mm stents(14.4% vs 3.5% ; P=.02), and multiple stents(57.8% vs 27.2% ; P< .001). Conclusion: Compared with a bare metal stent, implantation of the paclitaxel-eluting stent in a patient population with complex lesions effectively reduces clinical and angiographic restenosis. Context: Compared with bare metal stents, drug-eluting stents reduce restenosis in noncomplex lesions. The utility of drug-eluting stents has not been evaluated in more difficult stenoses. Objective: To investigate the safety and efficacy of the polymer-based, slow- release, paclitaxel-eluting stent in a patient population with more complex lesions than previously studied. Design, Setting, and Patients: Prospective, placebo-controlled, double-blind, multicenter randomized trial from February 2003 to March 2004 at 66 academic and community based institutions with 1156 patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4%) with complex or previously unstudied lesions , 4.0-mm, and / or multiple stents) and 9-month clinical and angiographic follow-up. Interventions: Patients were randomly assigned to receive 1 or more bare metal stents (n = 579) or identical-ap The mean (SD) reference vessel diameter (n = 577). Main Outcome Measure: Ischemia-driven target vessel revascularization at 9 months. Results: Baseline characteristics were well matched. was 2.69 (0.57) mm, the reference lesion length was 17.2 (9.2) mm, and 78% of lesions were type B2 / C. A mean (SD) of 1.38 (0.58) stents (total mean SD length, 28.4 13.1 mm) were compared with bare metal stents, paclitaxel-eluting stents reduced the 9- month rate of target lesion revascularization from 15.7% to 8.6% (P <.001) and target vessel revascularization from 17.3% to 12.1% (P = .02). Similar rates were observed for cardiac death or myocardial infarction (5.5% for bare metal stent group vs 5.7% for paclitaxel-eluting stent group) and stent thrombosis (0.7% in both groups). Angiographic restenosis was reduced from 33.9% to 18.9% in the entire study cohort (P <.001), including among patients receiving 2.25-mm stents (49.4% vs 31.2%; P = .01) vs 3.5%; P = .02), and multiple stents (57.8% vs 27.2%; P <.001). Conclusion: Compared with a bare metal stent, implantation of the paclitaxel-eluting stent in a patient population with complex hair effectively reduces clinical and angiographic restenosis.