India Medtronic Private Limited, wholly-owned subsidiary of Medtronic plc (NYSE:MDT), 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™ Drug Coated Stent[i] – 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% 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 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 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% versus 89.7%, respectively [p=0.007]. At one year, there was low (2.8%) target lesion revascularization (TLR) for Resolute Onyx versus 4.0% for the comparator stent. Additionally, stent thrombosis (ST) for Resolute Onyx was low (1.3%) versus BioFreedom (2.1%).
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% for Resolute Onyx vs. 8.8% for BioFreedom. Additionally, there was significantly lower MI – 4.3% for Resolute Onyx™ versus 6.8% for BioFreedom (p < 0.01).
The Resolute Onyx DES encourages fast vessel healing with its proprietary BioLinx™ polymer, a bio-compatible and non-thrombogenic coating created specifically for use on DES and unique platform design featuring Continuous Sinusoid Technology (CST), which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The Resolute Onyx DES received CE (Conformité Européene) Mark in September 2014 and FDA approval in April 2017.
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to the healthcare consumers and providers around the world.
BioFreedom is not currently approved for use in the United States. 2
Acute performance parameters were not powered or adjusted for multiplicity. 3
Post-hoc landmark analyses were not powered.
The Resolute Onyx DES is not contraindicated for high bleeding risk patients and there are no precautions listed in the IFU that would preclude high bleeding risk patients from intervention.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.