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(Circulation. 2009;120:1498-1504.)
© 2009 American Heart Association, Inc.

Interventional Cardiology

Final 5-Year Results of the TAXUS II Trial

A Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-Based Paclitaxel-Eluting Stents for De Novo Coronary Artery Lesions

Sigmund Silber, MD; Antonio Colombo, MD; Adrian P. Banning, MD; Karl Hauptmann, MD; Janusz Drzewiecki, MD; Eberhard Grube, MD; Dariusz Dudek, MD; Donald S. Baim, MD

From the Cardiology Practice and Hospital (S.S.), Munich, Germany; San Raffaele Scientific Institute (A.C.), Milan, Italy; John Radcliffe Hospital (A.P.B.), Oxford, United Kingdom; Krankenhaus der Barmherzigen Brüder (K.H.), Trier, Germany; Silesian Medical University (J.D.), Katowice, Poland; HELIOS Heart Center (E.G.), Siegburg, Germany; Jagiellonian University (D.D.), Krakow, Poland; and Boston Scientific Corporation (D.S.B.), Natick, Mass.

Correspondence to Sigmund Silber, MD, FACC, FESC, Cardiology Practice and Hospital, Am Isarkanal 36, D-81379 Munich, Germany. E-mail sigmund{at}silber.com

Received January 8, 2009; accepted July 27, 2009.

Background— The TAXUS II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based TAXUS paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions.

Methods and Results— This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare TAXUS SR (n=131) and TAXUS MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of TAXUS II. At 5 years, both TAXUS SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P=0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% (P=0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% (P<0.001) for the control, TAXUS SR, and TAXUS MR groups, respectively. The rates of all-cause death and myocardial infarction were low and similar between groups, with 2 stent thromboses with bare-metal stents compared with no event beyond 2 years with either of the TAXUS stents.

Conclusions— TAXUS II is the first large TAXUS trial to have reached 5-year follow-up. Both the SR and MR stents lowered the rates of target-vessel and target-lesion revascularization, which indicates their sustained efficacy. Furthermore, the low overall rates of all death, myocardial infarction, and stent thrombosis support the long-term safety of the TAXUS stent system.

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CLINICAL PERSPECTIVE

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Clinical Summaries
Circulation 2009 120: 1457-1458. [Extract] [Full Text]