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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus

Pooled Analysis From 5 Randomized Trials

Ajay J. Kirtane, MD, SM^_*,1, Stephen G. Ellis, MD^,1, Keith D. Dawkins, MD^,2, Antonio Colombo, MD, Eberhard Grube, MD^||, Jeffrey J. Popma, MD^¶,3, Martin Fahy, MSc^_*, Martin B. Leon, MD^_*,4, Jeffrey W. Moses, MD^_*,5, Roxana Mehran, MD^_*,6 and Gregg W. Stone, MD^_*,7,_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Cleveland Clinic, Cleveland, Ohio
Southampton University Hospital, Southampton, United Kingdom
San Raffaele Hospital, Milan, Italy
^|| Helios Heart Center Siegburg, Siegburg, Germany
^¶ Caritas St. Elizabeth’s Medical Center, Boston, Massachusetts.

Manuscript received August 22, 2007; revised manuscript received October 5, 2007, accepted October 8, 2007.

^_* Reprint requests and correspondence: Dr. Gregg W. Stone, Columbia University Medical Center, The Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022. (Email: gs2184{at}columbia.edu).

Objectives: We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).

Background: Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials.

Methods: Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6%) with DM.

Results: Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p = 0.61), myocardial infarction (6.9% vs. 8.9%, p = 0.17), or stent thrombosis (1.4% vs. 1.2%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4% vs. 24.7%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin.

Conclusions: In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis.

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   DM = diabetes mellitus   HR = hazard ratio   IDDM = insulin-dependent diabetes mellitus   MI = myocardial infarction   NIDDM = noninsulin-dependent diabetes mellitus   PES = paclitaxel-eluting stent(s)   RVD = reference vessel diameter   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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