Clinical efficacy and safety of biodegradable polymer‐based sirolimus‐eluting stents in patients with diabetes mellitus insight from the 4‐year results of the create study

Abstract

Diabetes mellitus is an independent predictor of adverse clinical events after drug-eluting stent implantation. The objective of this study is to evaluate the long-term clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in diabetic versus non-diabetic patients. A total of 2077 "all comers," including 440 (21.2%) diabetic patients and 1637 (78.8%) non-diabetic patients, were prospectively enrolled in the CREATE study at 59 centers in four countries. The recommended antiplatelet regimen was clopidogrel and aspirin for 6 months followed by chronic aspirin therapy. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR). Diabetic patients had higher risks of all-cause death (8.2% vs. 3.4%, P < 0.001) and cardiac death (4.1% vs. 1.4%, P < 0.001) compared with non-diabetic patients at 4 years. The rates of non-fatal MI (0.2% vs. 0.9%, P = 0.218), TLR (2.0% vs. 2.8%, P = 0.357), MACE (5.9% vs. 4.4%, P = 0.227), and overall stent thrombosis (1.6% vs. 1.6%, P = 0.932) were not significantly different between diabetic and non-diabetic patients. A landmark analysis showed that prolonged clopidogrel therapy (>6 months) was not beneficial in reducing the cumulative hazards of MACE either in diabetic or non-diabetic patients (log rank P = 0.810). Biodegradable polymer-based sirolimus-eluting stents for the treatment of diabetic patients had a similar clinical event rate at 4 years compared with non-diabetic patients, except for a higher mortality rate.