2-Year Outcomes After Polymer-Free Drug-Coated Stents

Study Questions:

What is the safety and efficacy of a polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy (DAPT) at 2 years?


In LEADERS FREE, a prospective, multicenter, double-blind trial, the investigators randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a bare-metal stent (BMS) followed by 1-month DAPT. The primary safety endpoint was a composite of cardiac death, myocardial infarction (MI), or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.


At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.64-0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (HR, 0.54; 95% CI, 0.41-0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (MI and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS.


The authors concluded that safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients.


This study reports that the safety and efficacy benefits of a polymer-free biolimus A9-eluting stent versus a BMS together with a short 1-month DAPT course were maintained during 2 years of follow-up. Additional prospective studies are needed to define the optimum intensity and duration of DAPT for patients undergoing percutaneous coronary intervention characterized based on bleeding risk, coronary pathoanatomy and stability, procedural complexity, and the number and types of stents deployed. In addition, future trials, rather than relying simply on traditional infrequent endpoints such as MI and stroke, should consider using all-cause death and all-cause rehospitalization as a metric that takes into account efficacy, safety, and health care costs.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and ACS

Keywords: Acute Coronary Syndrome, Anemia, Creatinine, Drug-Eluting Stents, Heart Failure, Hemorrhage, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Polymers, Stents, Thrombosis

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