Author + information
- Received August 22, 2007
- Revision received October 5, 2007
- Accepted October 8, 2007
- Published online February 19, 2008.
- 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,⁎ ()
- ↵⁎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.
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.
- Received August 22, 2007.
- Revision received October 5, 2007.
- Accepted October 8, 2007.
- American College of Cardiology Foundation