Clinical Outcomes in Patients Treated With Biodegradable-Polymer Biolimus-Eluting Stents and 6 Months of Dual-Antiplatelet Therapy: The French eBiomatrix 6-Month DAPT Registry

Abstract

Background: Dual-antiplatelet treatment (DAPT) has conventionally been prescribed for 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Recent evidence suggests that a duration of only 6 months may be equally safe and effective when using contemporary DES options.

Objective: The aim of this study was to assess clinical outcomes in patients treated with the BioMatrix biodegradable-polymer coated biolimus-eluting stent (BP-BES; Biosensors International) who received only 6 months of DAPT.

Methods: This prospective "all-comers" registry enrolled 2038 patients in France. Following PCI, DAPT was started for a recommended period of 6 months. Patients were followed up at 6 and 24 months. The primary endpoint of major adverse cardiac and cerebrovascular event (MACCE) was a composite of all-cause death, cerebrovascular accidents, non-fatal myocardial infarction, or clinically driven target-vessel revascularization. Secondary endpoints included stent thrombosis (ST) and major bleeding (MB).

Results: The mean age of the study population was 67 ± 10.5 years and 77% of patients were male. Follow-up data were available in 96.9% and 95.3% of patients at 6 and 24 months, respectively. At 6 months, the incidences of MACCE, ST, and MB were 3.1%, 0.3%, and 0.4%, respectively. At 24 months, 21.2% of patients were still on DAPT and the cumulative incidences of MACCE, ST, and MB were 9.7%, 0.54%, and 0.79%, respectively.

Conclusions: In this unselected population of patients undergoing PCI with a BP-BES, a 6-month duration of DAPT after implantation is safe and effective.

Keywords: dual-antiplatelet treatment; percutaneous coronary intervention; stent thrombosis.