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TAXUS Liberté Attenuates the Risk of Restenosis in Patients With Medically Treated Diabetes Mellitus

Results From the TAXUS ATLAS Program

Ehtisham Mahmud, MD, FACC^_*,_*, John A. Ormiston, MBChB, Mark A. Turco, MD, FSCAI, Jeffrey J. Popma, MD, Neil J. Weissman, MD^||, Charles D. O'Shaughnessy, MD^¶, Tift Mann, MD^#, Jack J. Hall, MD^_**, Thomas F. McGarry, MD, Louis A. Cannon, MD, Mark W.I. Webster, MD, Lazar Mandinov, MD^||||, Donald S. Baim, MD^||||

^_* University of California, San Diego, San Diego, California
Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand
Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland
Angiographic Core Laboratory, Brigham and Women's Hospital, Boston, Massachusetts
^|| Cardiovascular Research Institute, Washington Hospital Center, Washington DC
^¶ North Ohio Research Center, Elyria, Ohio
^# Wake Heart Associates, Wake Medical Center, Raleigh, North Carolina
^_** The Heart Center, St. Vincent's Hospital, Indianapolis, Indiana
Oklahoma Heart Hospital, Oklahoma City, Oklahoma
Cardiac & Vascular Research Center, Northern Michigan Hospital, Petoskey, Michigan
Auckland City Hospital, Auckland, New Zealand
^|||| Boston Scientific Corporation, Natick, Massachusetts

^_* Reprint requests and correspondence: Dr. Ehtisham Mahmud, UC San Diego Medical Center, Cardiovascular Catheterization Labs, 200 West Arbor Drive, San Diego, California 92103-8784 (Email: emahmud{at}ucsd.edu).

Objectives: The aim of this study was to assess the relative efficacy and safety of the second-generation TAXUS Liberté paclitaxel-eluting stent (PES) in patients with and without diabetes mellitus.

Background: Diabetic patients suffer from accelerated atherosclerosis and increased risk of restenosis after coronary interventions; however, prior data suggest that PES might blunt this effect, providing equal benefit in diabetic and nondiabetic patients.

Methods: A pooled analysis of all 4 TAXUS ATLAS studies was conducted that included 413 diabetic and 1,116 nondiabetic subjects treated with the TAXUS Liberté stent for de novo coronary lesions. Angiographic and intravascular ultrasound outcomes at 9 months and clinical outcomes at 9 and 12 months were compared in patients with and without diabetes. Propensity score and multivariate adjustments were performed to correct for baseline differences.

Results: In-stent angiographic restenosis (13.0% vs. 9.6%, p = 0.12), late luminal loss (0.40 mm vs. 0.38 mm, p = 0.58), and intimal hyperplasia (14.8% vs. 13.4%, p = 0.29) were similar for diabetic and nondiabetic subjects. After propensity adjustment, 12-month target lesion revascularization rates were similar for diabetic and nondiabetic subjects (6.4% vs. 4.7%, p = 0.18), with no differences in mortality, myocardial infarction, or stent thrombosis. However, the rate of target vessel revascularization (TVR) was higher for diabetic subjects due to increased TVR outside the target lesion (TVR Remote).

Conclusions: Similar clinical, angiographic, and intravascular ultrasound outcomes were observed for both diabetic and nondiabetic subjects treated with TAXUS Liberté, suggesting that this PES attenuates the effect of diabetes on restenosis after percutaneous coronary intervention, yielding comparable efficacy and safety in diabetic and nondiabetic patients. (TAXUS ATLAS; NCT00371709, NCT00371423, NCT00371748, and NCT00371475)

Key Words: coronary artery disease • diabetes • drug-eluting stent • paclitaxel

Abbreviations and Acronyms   %DS = percent diameter stenosis   CI = confidence interval   HR = hazard ratio   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimum lumen diameter   PES = paclitaxel-eluting stent(s)   RVD = reference vessel diameter   TLR = target lesion revascularization   TVR = target vessel revascularization

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