The primary endpoint results of the LEADERS FREE II trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA). They confirm that the favourable results gained earlier for the BioFreedom stent in the European LEADERS FREE trial are reproducible and generalisable to clinical practice for high-bleeding risk patients in North America. The trial findings were presented by Mitchell W Krucoff (Duke University, Durham, USA).
LEADERS FREE II sought to confirm superior efficacy and non-inferiority safety outcomes of the BioFreedom drug-coated stent in comparison with the historic Gazell bare metal stent arm of the LEADERS FREE study in high bleeding risk patients, who received only one month of dual anti-platelet therapy (DAPT). The primary safety endpoint was defined as the composite of cardiac death and myocardial infarction at twelve months; and the primary efficacy endpoint is defined as the incidence of clinically driven target lesion revascularisation at 12 months. A total of 1,203 coronary artery disease patients at high bleeding risk received BioFreedom stents together with an ultra-short one-month DAPT regimen. Patient selection, endpoint definitions, core laboratories, and clinical event adjudication rules were kept identical to LEADERS FREE.
At one-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 vs. 12.6% for patients who received a bare metal stent in LEADERS FREE (p=0.0025 for superiority). The primary efficacy endpoint, clinically indicated target lesion revascularisation, was reached by 6.1% of patients receiving BioFreedom vs. 9.3% of patients in the bare-metal stent control arm (p=0.0111 for superiority). The rate of BARC 3-5 major bleeding was 7% for BioFreedom patients vs. 7.2% in the historic LEADERS FREE bare-metal stent control arm (p=0.7970).
Krucoff comments: “LEADERS FREE II reassures the medical community that the favourable 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 generalisable to the clinical practice
Simon Li, the CEO and group xhairman of Biosensors International, states: “The positive data from LEADERS FREE II are a key milestone in our effort to provide the BioFreedom drug-coated stent to the American market. We look forward to continuing our FDA submission towards approval for the USA.”