The leaders free trial: A double blind randomized comparison of a BMS and a polymer-free Drug Coated Stent (DCS) in 2,466 patients at high bleeding risk and treated with one month DAPT only.

Abstract

Background A sizeable proportion of patients treated with PCI are unable to take dual antiplatelet therapy (DAPT) for the guideline-recommended time period of 6-12 months. Optimal treatment of pts at high bleeding risk thus remains uncertain. The BioFreedomTM DCS (Biosensors, Europe SA, Morges, Switzerland) is polymer- and carrier-free, releases Biolimus A9 into the vessel wall over a period of 4 weeks, and then technically becomes a BMS. Methods 2,466 pts at high bleeding risk from 68 centers in Europe, Asia, and Canada were enrolled over an 18 months period in a doubleblinded randomized 1:1 comparison of the GazelleTM BMS vs. the BioFreedom DCS (both Biosensors, Morges, CH) with a 1 month course of DAPT only in both arms. At 1 year, the primary endpoints are: safety: a composite of cardiovascular death, MI and stent thrombosis, and efficacy: the rate of ci-TLR. Current results In the trial population, the most frequently used inclusion criteria were: advanced age (64%), need for long term oral anticoagulation (36%), anemia, recent bleeding or transfusion (20%), renal insufficiency (18%), planned surgery (15%) and concomitant cancer (9%). When compared to those included in 'all-comer' trials, pts were markedly older (75 years) and had more co-morbidiites (diabetes 33%, atrial fibrillation 33%, peripheral vascular disease 15%, heart failure 13%, prior stroke 9% and COPD 11%) 1.5 lesions/pts were treated and 1.7 stents/pts were implanted for a total stent length of 32mm/patient. Technical procedure success was 95%. 71% of pts were discharged on DAPT alone, 27% of DAPT+oral anticoagulation and 2% on a single antiplatelet agent + oral anticoagulation. Conclusion The trial focuses on a never previously studied high bleeding risk population characterized by advanced age and more comorbid conditions. It is the 1st evaluation of a DCS with clinical endpoints and comprises the shortest ever DAPT course with an active stent to be evaluated for both safety and efficacy.