Biosensors International Group, Ltd. and BlueSail Medical (Biosensors or the “Company”, stock exchange code 002382.SZ), a developer, manufacturer and marketer of innovative medical devices, announced today that primary endpoint results of the LEADERS FREE II trial were presented at the TCT 2018 conference in San Diego, CA, USA.
San Diego 22 September 2018 – Biosensors International Group, Ltd. and BlueSail Medical (Biosensors or the “Company”, stock exchange code 002382.SZ), a developer, manufacturer and marketer of innovative medical devices, announced today that primary endpoint results of the LEADERS FREE II trial were presented at the TCT 2018 conference in San Diego, CA, USA. In brief, the outcomes of the new trial confirm that the favorable results gained earlier for the BioFreedom™ stent in the European LEADERS FREE trial are reproducible and generalizable to clinical practice for high-bleeding risk patients in North America.
The trial findings were presented by Dr. Mitchell W. Krucoff, Principal Investigator for LEADERS FREE II, at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
LEADERS FREE II is the company’s new BioFreedom™ Pivotal Trial, conducted under an FDA Investigational Device Exemption (IDE). It is a prospective single-arm study of the BioFreedom™
Biolimus A9™ drug-coated stent (DCS) with the therapeutic focus on patients at high risk for bleeding (HBR), who receive an ultra-short dual anti-platelet drug regimen of only 1 month.
This study aims to confirm superior efficacy and non-inferiority safety outcomes of the BioFreedom™ DCS in comparison with the historic Gazelle™ bare metal stent arm of the LEADERS FREE study in high bleeding risk patients, who receive only one month of dual anti-platelet therapy. The primary safety endpoint is 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 revascularization at 12 months. A total of 1,203 coronary artery disease patients at high bleeding risk received BioFreedom™ stents together with an ultra-short 1-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™, compared to 12.6% in the bare-metal stent cohort of LEADERS FREE, HR: 0.67 (95% CI = 0.51 – 0.88), P=0.0025 for superiority. The primary efficacy endpoint, 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, HR 0.63 (95% CI = 0.45 – 0.87), P=0.0111 for superiority. The rate of BARC 3-5 major bleeding was 7.0% for BioFreedom™ patients, vs 7.2% in the historic LEADERS FREE bare-metal stent control arm (P=0.7970). There was also a close similarity of the event rates for BioFreedom™ patients in the new trial, with BioFreedom™ patients in LEADERS FREE.
Dr. Mitchell W. Krucoff from Duke University, NC, USA, the Principle Investigator of the trial, stated “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.”
Dr Philip Urban from La Tour Hospital in Geneva, Switzerland, was the Principal Investigator of the LEADERS FREE trial, and is the European co-Principal Investigator for LEADERS FREE II.
Dr. Marty Leon, from Columbia University, New York, the Chairman of the Executive Physician Committee, commented: “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.”
The BioFreedom™ DCS has been implanted to date in over 150,000 patients in more than 40 countries outside the United States. It is not available in the United States or any other country where applicable health authority product registration has not been obtained.
Simon Li, the CEO and Group Chairman of Biosensors International stated: “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 United States.”
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