Clinical Research
Interventional Cardiology
Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus: Pooled Analysis From 5 Randomized Trials

https://doi.org/10.1016/j.jacc.2007.10.035Get rights and content
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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

Cited by (0)

1

Dr. Kirtane has received honoraria from Boston Scientific; Dr. Ellis has received consulting fees from Boston Scientific and Cordis.

2

Dr. Dawkins has received research grant support from Boston Scientific and consulting fees from Boston Scientific, Abbott Vascular, and Conor.

3

Dr. Popma has received consulting fees and research grant support from Boston Scientific, Abbott Vascular, Cordis, and Medtronic.

4

Dr. Leon has received consulting fees from Cordis, Abbott Vascular, Medtronic, and Boston Scientific.

5

Dr. Moses has received consulting fees from Cordis.

6

Dr. Mehran has received research grant support from Boston Scientific, Cordis, and Conor.

7

Dr. Stone has received lecture fees from Boston Scientific, Abbott Vascular, and Medtronic; has equity interests in Devax and XTENT; has received consulting fees from Boston Scientific, Abbott Vascular, Guidant, and XTENT; and is on the Board of Directors of Devax.