Circulation. 2003;108:788-794
Published online before print August 4, 2003, doi: 10.1161/01.CIR.0000086926.62288.A6
Published online before print August 4, 2003, doi: 10.1161/01.CIR.0000086926.62288.A6
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(Circulation. 2003;108:788.)
© 2003 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-Based Paclitaxel-Eluting Stents for Coronary Artery Lesions
From Ospedale San Raffaele, Milano, Italy (A.C.); PSK No 7 Zaklad Kardiologii, Katowice, Poland (J.D.); John Radcliffe Hospital, Oxford, Great Britain (A.B.); Krankenhaus Siegburg, Siegburg, Germany (E.G.); Krankenhaus der Barmherzigen Brüder, Trier, Germany (K.H.); Internistische Klinik Dr. Müller, Munich, Germany (S.S.); Jagiellonian University, Krakow, Poland (D.D.); Sunnybrook & Women’s College Health Sciences Center, Toronto, Canada (S.F.); Centre Hospitalier Universitaire Jean Minjoz, Besancon ,France (F.S.); Jan Pawel II Hospital, International Cardiology Clinic, Krakow, Poland (K.Z.); Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); and Boston Scientific Corporation, Natick, Mass (M.E.R.).
Correspondence to Antonio Colombo, MD, Director, Cardiac Catheterization Laboratory, EMO Centro Cuore Columbus S.r.l., Sede Operativa c/o Casa Cura Columbus, Via M. Buonarroti, 48 20145 Milano, Italy. E-mail colombo{at}emocolumbus.it
Received June 18, 2003; revision received July 8, 2003; accepted July 8, 2003.
Background— Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.
Methods and Results— We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Conclusions— Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
Key Words: coronary disease • drugs • stents • restenosis
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