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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Incidence, Timing, and Correlates of Stent Thrombosis With the Polymeric Paclitaxel Drug-Eluting Stent

A TAXUS II, IV, V, and VI Meta-Analysis of 3,445 Patients Followed for Up to 3 Years

Stephen G. Ellis, MD, FACC^_*,_*, Antonio Colombo, MD, FACC, Eberhard Grube, MD, FACC, Jeffrey Popma, MD, FACC, Joerg Koglin, MD, FACC^||, Keith D. Dawkins, MD, FACC^¶ and Gregg W. Stone, MD, FACC^#

^_* The Cleveland Clinic, Cleveland, Ohio
Columbus Hospital, Milan, Italy
Heart Center Siegburg, Siegburg, Germany
Brigham and Women's Hospital, Boston, Massachusetts
^|| Boston Scientific Corporation, Natick, Massachusetts
^¶ Southampton University Hospital, Southampton, United Kingdom
^# Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York

Manuscript received July 26, 2006; revised manuscript received January 2, 2007, accepted January 9, 2007.

^_* Reprint requests and correspondence: Dr. Stephen G. Ellis, Department of Cardiovascular Medicine, The Cleveland Clinic, 9500 Euclid Avenue, F25, Cleveland, Ohio 44195 (Email: elliss{at}ccf.org).

Data presented in part at the Transcatheter Cardiovascular Therapeutics Conference, October 23 to 27, 2005, Washington, DC, and the American College of Cardiology Foundation Annual Scientific Session, March 11 to 14, 2006, Atlanta, Georgia.

Objectives: This study sought to study stent thrombosis with the paclitaxel-eluting Taxus stent.

Background: The incidence and timing of stent thrombosis after drug-eluting stent placement compared with bare-metal stent implantation remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications.

Methods: This study used a patient-based meta-analysis using the 4 principal TAXUS randomized trials (3,445 patients) with a follow-up duration of 1 year.

Results: Cumulative stent thrombosis occurred in 1.28% ± 0.31% in the Taxus group and 0.76% ± 0.23% in the bare-metal stent group at 3 years (hazard ratio 1.51 [95% confidence interval 0.73 to 3.14], p = 0.26). Hazard ratios (per 100 patients per 6 months) were similar between the Taxus stent group (0.59 [95% confidence interval 0.22 to 0.95]) and the bare-metal stent group (0.64 [95% confidence interval 0.26 to 1.02]) through 6 months during the prescribed clopidogrel period. However, from 6 months to 3 years there were more stent thromboses in the Taxus group (hazard ratio 0.19 [95% confidence interval 0.06 to 0.32] vs. 0.02 [95% confidence interval 0.00 to 0.07], p = 0.049). Of 8 patients with Taxus-related thrombosis after 6 months, 0 were taking clopidogrel and 2 were not taking aspirin consistently. No Taxus-related stent thrombosis occurred after 2 years (922 patients thus far followed up for 3 years). Independent correlates of stent thrombosis were nonuse of clopidogrel, male gender, smoking, and possibly use of multiple nonoverlapping stents.

Conclusions: Approximately 0.8% of Taxus patients have stent thrombosis in the first 6 months after stent implantation, similar to bare-metal stents. However, a modest increase in risk is present with Taxus stents beyond 6 months, possibly because of inadequate antiplatelet drug therapy.

Abbreviations and Acronyms   BMS = bare-metal stent   DES = drug-eluting stent   MACE = major adverse cardiac event   TVR = target vessel revascularization

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