Polymer-free drug-coated stent bests bare-metal stent in high bleeding risk patients

Patients at a high risk for bleeding who took a 1-month course of dual anti-platelet therapy fared better with a polymer-free drug-coated stent than with a bare metal stent after 2 years, according to results from the Leaders Free trial presented yesterday at the conference.

The study, also published in the Journal of the American College of Cardiology, compared a month of DAPT therapy and either the BioFreedom biolimus A9-coated stent made by BioSensors International or its Gazelle BMS.

The nearly 2,500-patient trial had a composite primary safety endpoint of cardiac death, myocardial infarction or stent thrombosis and a primary efficacy endpoint of clinically driven target-lesion revascularization. The primary safety endpoint at two years was 12.6% for the BioFreedom-treated cohort, compared to 15.3% for the BMS group. The results for the primary efficacy endpoint were 6.8% for the BioFreedom arm versus 12.0% for the BMS arm.

Major bleeding occurred in 8.9% of the drug-coated stent group and 9.2% of the bare metal cohort. The rate of coronary thrombotic event was 8.2% for the DCS arm and 10.6% for BMS patients. Subsequent mortality was 27.1% a year after a major bleed and 26.3% a year after a thrombotic event.

“The 2-year results from the Leaders Free trial clearly show that the use of a polymer-free biolimus A9-coated stent was both significantly safer and more effective than a bare-metal stent for patients at high risk of bleeding treated with a 1-month course of DAPT,” lead investigator Dr. Philip Urban, of Geneva’s La Tour Hospital, said in prepared remarks. “These patients suffer from a persistently high incidence of bleeding and coronary thrombotic events, both of which are associated with a high and similar mortality over a 1-year period. Therefore, identification of predictors of both the composite primary safety event and major bleeding may help design future trials of DAPT duration for this population.”