Impact of Coronary Lesion Complexity on Drug-Eluting Stent Outcomes in Patients With and Without Diabetes Mellitus: Analysis From 18 Pooled Randomized Trials

doi:10.1016/j.jacc.2014.01.064

Journal of the American College of Cardiology

Volume 63, Issue 20, 27 May 2014, Pages 2111-2118

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Objectives

The aim of this study was to investigate whether baseline lesion complexity affects drug-eluting stent (DES) outcomes according to diabetic status.

Background

Previous studies have reported conflicting results regarding DES safety and efficacy in patients with and without diabetes mellitus (DM).

Methods

Patient-level data from 18 prospective randomized trials were pooled. DES treatment outcomes in patients with versus without DM were analyzed in 2 propensity score–matched groups further stratified according to lesion complexity (American College of Cardiology and American Heart Association class A/B1 vs. B2/C). Remaining baseline differences were adjusted for by multivariate analysis.

Results

DM was present in 3,467 of 18,441 patients (18.8%). DM was a predictor of 1-year repeat revascularization (target lesion revascularization: hazard ratio: 1.34; 95% confidence interval: 1.05 to 1.70; target vessel revascularization: hazard ratio: 1.40; 95% confidence interval: 1.15 to 1.72) and cardiac death or myocardial infarction (hazard ratio: 1.40; 95% confidence interval: 1.09 to 1.81). Rates of target lesion and target vessel revascularization were significantly higher in patients with versus those without DM with type B2/C lesions (8.0% vs. 4.5% and 10.6% vs. 5.9%, respectively, p < 0.0001 for both), but not in patients with only type A/B1 lesions (4.6% vs. 4.8%, p = 0.87, and 7.4% vs. 6.8%, p = 0.47, respectively), with a significant interaction between DM and lesion type observed for both endpoints (p = 0.01 and p = 0.02, respectively). No interaction was observed for death or myocardial infarction (p = 0.28).

Conclusions

In the DES era, patients with DM remain at increased risk for cardiac death or myocardial infarction. However, DM is a risk factor for repeat revascularization only in those patients with complex lesions; patients with DM and noncomplex lesions have similar rates of 1-year freedom from repeat revascularization as do patients without DM.

Key Words

diabetes mellitus

drug-eluting stent(s)

prognosis

Abbreviations and Acronyms

ACC

American College of Cardiology

AHA

American Heart Association

BMS

bare-metal stent(s)

CABG

coronary artery bypass grafting

confidence interval

DES

drug-eluting stent(s)

diabetes mellitus

hazard ratio

MACE

major adverse cardiac event(s)

myocardial infarction

PCI

percutaneous coronary intervention

TLR

target lesion revascularization

TVR

target vessel revascularization

Cited by (0)

: Dr. Kedhi has received lecture fees from Abbott Vascular. Drs. Généreux and Palmerini have received lecture fees from Abbott Vascular. Dr. Mehran is a consultant and advisor to AstraZeneca, Janssen (Johnson & Johnson), Regado Biosciences, Abbott, Merck Sharp & Dohme, Maya Medical, Covidien, and Boston Scientific; and has received research grant support (institutional) from Bristol-Myers Squibb/Sanofi, The Medicines Company, Eli Lilly/Daiichi Sankyo, and St. Jude Medical. Dr. Dangas is a consultant to Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, and Janssen; and has received institutional research grant support from Bristol-Myers Squibb/Sanofi, Eli Lilly/Daiichi Sankyo, Regado Biosciences, Maya Medical, Merck, and The Medicines Company. Dr. Stone has served as a consultant to Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.