Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: a report from the National Heart, Lung, and Blood Institute Dynamic Registry

Abstract

Background: Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry.

Methods and results: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed.

Conclusions: PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.

Figure 1. Two-Year Death/MI Rates

Kaplan-Meier 2-year curves of the incidence of the composite endpoint of death or myocardial infarction. (PES: Paclitaxel-eluting stents, SES: Sirolimus-eluting stents)

Figure 2. Two-Year Revascularization Rates

Kaplan-Meier 2-year curves of the incidence of the composite endpoint of post-discharge repeat PCI or CABG. (PES: Paclitaxel-eluting stents, SES: Sirolimus-eluting stents)

Figure 3. Adjusted Hazard Ratios of SES and PES in Patients with Diabetes

Adjusted hazard ratios (solid rectangles) and 95% confidence intervals (horizontal lines) for safety and efficacy outcomes at 2 years comparing PES versus SES. Variables adjusted for death included: age, renal disease, acute myocardial infarction (MI), beta blockers at discharge, history heart failure, clopidogrel/ticlopidine at discharge, cardiogenic shock, and prior CABG. Variables adjusted for MI included: 3-vessel disease, unstable angina, use of insulin, renal disease, attempting a class C lesion, AMI, and prior CABG. Variables adjusted for Death/MI included: age, cardiogenic shock, peripheral vascular disease (PVD), history of heart failure, use of oral medications for diabetes, AMI, renal disease, attempting a class C lesion, prior CABG, clopidogrel/ticlopidine at discharge, and at least 2 of the following at discharge: beta blockers, calcium channel blockers, long-acting nitrates, ACE inhibitors, statins. Variables adjusted for CABG/repeat PCI included: unstable angina, number of significant lesions, PVD, attempting a class C lesion, and at least 2 of the following at discharge: beta blockers, calcium channel blockers, long acting nitrates, ACE inhibitors, statins. Variables adjusted for stent thrombosis included: age, pulmonary disease, renal disease, use of insulin, attempting lesion supplying collaterals, attempting a lesion w/ thrombus, and attempting a bifurcating lesion. (PES: Paclitaxel-eluting stents, SES: Sirolimus-eluting stents)