LEADERS FREE II Pivotal Trial Data Presented for Biosensors' Drug-Coated Stent

September 22, 2018—Biosensors International Group, Ltd. and BlueSail Medical announced that primary endpoint results of the LEADERS FREE II trial were presented by Mitchell W. Krucoff, MD, at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California.

Biosensors stated that the outcomes of the trial confirm that the favorable results gained earlier for the company's BioFreedom stent in the European LEADERS FREE trial are reproducible and generalizable to clinical practice for high-bleeding-risk patients in North America.

The LEADERS FREE II is the prospective single-arm United States BioFreedom pivotal trial conducted under an FDA investigational device exemption. The trial is evaluating the BioFreedom biolimus A9 drug-coated stent (DCS) with the therapeutic focus on patients at high risk for bleeding (HBR) who receive an ultrashort dual antiplatelet therapy (DAPT) of 1 month.

According to the company, the study aims to confirm superior efficacy and noninferior safety outcomes of the BioFreedom DCS in comparison with the historic bare-metal stent (Gazelle, Biosensors International Group, Ltd.) arm of the LEADERS FREE study in high-bleeding-risk patients who receive 1 month of DAPT.

The primary safety endpoint is defined as the composite of cardiac death and myocardial infarction at 12 months. The primary efficacy endpoint is defined as the incidence of clinically driven target lesion revascularization at 12 months.

A total of 1,203 coronary artery disease patients at high bleeding risk received BioFreedom stents together with an ultrashort DAPT regimen. Patient selection, endpoint definitions, core laboratories, and clinical event adjudication rules were kept identical to LEADERS FREE.

At 1-year follow-up, the incidence of the primary safety endpoint, a composite of cardiac death and myocardial infarction, was 8.6% for patients receiving BioFreedom versus 12.6% in the bare-metal stent cohort of LEADERS FREE (hazard ratio, 0.67; 95% confidence interval, 0.51–0.88; P_superiority = .0025).

The primary efficacy endpoint of clinically indicated target lesion revascularization was reached by 6.1% of patients receiving BioFreedom versus 9.3% of patients in the bare-metal stent control arm from LEADERS FREE (hazard ratio, 0.63; 95% confidence interval, 0.45–0.87; P_superiority = .0111).

The rate of Bleeding Academic Research Consortium 3–5 major bleeding was 7% for BioFreedom patients versus 7.2% in the historic LEADERS FREE bare-metal stent control arm (P = .797). In the new trial, the event rates for BioFreedom patients there were closely similar to the rates of BioFreedom patients in LEADERS FREE.

Dr. Krucoff, who serves as Principal Investigator of the trial, commented in the company's press release, “LEADERS FREE II reassures the medical community that the favorable findings for the BioFreedom biolimus-A9 drug-coated stent in high bleeding risk patients gained from the European LEADERS FREE trial are not only reproducible but also generalizable to the clinical practice for such patients in North America.” In addition to Dr. Krucoff, the European Coprincipal Investigator for LEADERS FREE II trial is Philip Urban, MD, who served as the Principal Investigator of the LEADERS FREE trial.

Also commenting in the Biosensors announcement, Martin Leon, MD, stated, “The LEADERS FREE II data set constitutes the first robust evidence for safety and efficacy of an active stent with a DAPT regimen of only 1 month for patients at high bleeding risk in the United States. It addresses a truly unmet clinical need for these patients.”