Mumbai (Maharashtra)/New Delhi [India] Jan 25 (ANI/BusinessWire India): India Medtronic Private Limited, wholly-owned subsidiary of Medtronic plc, today announced the clinical data from the Onyx ONE Global Study, representing the first prospective, multi-center, randomized study evaluating clinical outcomes between two drug-eluting stents (DES) in nearly 2,000 high-bleeding risk (HBR) patients with one month of dual antiplatelet therapy (DAPT).
In the study, Resolute Onyx met the primary composite endpoint of cardiac death, myocardial infarction (MI) or stent thrombosis (ST) at one-year demonstrating non-inferiority versus the comparator stent, BioFreedom(tm) Drug-Coated Stent - the only DES recommended by the European Society for Cardiology (ESC) in its guidelines for HBR patients that need one-month DAPT.
Results of Onyx ONE Global Study were first presented during a late-breaking clinical trial session at the 31st Transcatheter Cardiovascular Therapeutics Conference (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco held in September 2019.
"High bleeding risk patients are an important, growing and complex population which make up nearly 30-40 per cent of PCI and have been often excluded from drug-eluting stent trials. The Onyx ONE study addresses this important 'need of the hour' by providing physicians with a comprehensive and robust data set that helps build highly effective treatment options with latest generation of thin strut drug-eluting stent (Onyx) for those patients who are at a high risk of bleeding and may be harmed by the longer course of DAPT", said Dr Ashok Seth, Chairman of Fortis Escorts Heart Institute, New Delhi.
The Onyx ONE Global Study is representative of the complex clinical practice of HBR patients including those with anticoagulant use, renal failure, upcoming surgery, and recent blood transfusion.
The study protocol did not exclude patients based on the disease state or anatomical complexity. The Onyx ONE Global Study and Onyx ONE Clear Study make up the Medtronic Onyx ONE Month DAPT Program that has enrolled approximately 2,700 patients at up to 140 sites worldwide.
"Medtronic is committed to pioneering the practice of evidence-based medicine in the medical device industry in India. Resolute Onyx drug-eluting stent continues to deliver excellent outcomes for a wide range of patients. To date, more than 20,000 patients have been studied in Medtronic clinical trials that have addressed DAPT duration. Having completed 40 years in India, Medtronic's vision remains anchored on introducing innovations that continue to alleviate pain, restore health and extend life. We are happy to continue serving patients and improving lives through world-class therapies that are backed by robust clinical data", said Madan Krishnan, Vice President, Medtronic Indian Subcontinent.
In addition to meeting the primary endpoint, the study showed superior acute performance2 for Resolute Onyx versus BioFreedom, with superior device success of 92.8 per cent versus 89.7 per cent, respectively [p=0.007]. At one year, there was low (2.8 per cent) target lesion revascularization (TLR) for Resolute Onyx versus 4.0 per cent for the comparator stent. Additionally, stent thrombosis (ST) for Resolute Onyx was low (1.3 per cent) versus BioFreedom (2.1 per cent).
A landmark analysis conducted after discontinuation of DAPT at one month showed low event rates for Resolute Onyx3. At one year, the composite endpoint (cardiac death, ST, myocardial infarction [MI]) of this analysis was 7.5 per cent for Resolute Onyx vs. 8.8 per cent for BioFreedom. Additionally, there was significantly lower MI - 4.3 per cent for Resolute Onyx(tm) versus 6.8 per cent for BioFreedom (p