Impact of coronary lesion complexity on drug-eluting stent outcomes in patients with and without diabetes mellitus: analysis from 18 pooled randomized trials.

Kedhi, Elvin; Généreux, Philippe; Palmerini, Tullio; McAndrew, Thomas C; Parise, Helen; Mehran, Roxana; Dangas, George D; Stone, Gregg W

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.