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A Randomized Controlled Trial

Gregg W. Stone, MD; Stephen G. Ellis, MD; Louis Cannon, MD; J. Tift Mann, MD; Joel D. Greenberg, MD; Douglas Spriggs, MD; Charles D. O'Shaughnessy, MD; Samuel DeMaio, MD; Patrick Hall, MD; Jeffrey J. Popma, MD; Joerg Koglin, MD; Mary E. Russell, MD; for the TAXUS V Investigators

JAMA. 2005;294:1215-1223.

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.

Author Affiliations: Department of Cardiology, Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY (Dr Stone); Department of Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Ellis); Department of Cardiology, Northern Michigan Hospitals, Petoskey (Dr Cannon); WakeMed, Raleigh, NC (Dr Mann); Department of Cardiology, Florida Heart Institute, Orlando (Dr Greenberg); Department of Cardiology, Morton Plant Hospital, Clearwater, Fla (Dr Spriggs); Department of Cardiology, Elyria Memorial Hospital, Elyria, Ohio (Dr O'Shaughnessy); Department of Cardiology, South Austin Hospital, Austin, Tex (Dr DeMaio); Department of Cardiology, South Carolina Heart Center, Columbia (Dr Hall); Department of Cardiology, Brigham and Women’s Hospital, Boston, Mass (Dr Popma); and Boston Scientific Corp, Natick, Mass (Drs Koglin and Russell).

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