Medtronic Bangladesh Pvt Ltd announced the clinical data from Onyx ONE Global Study. The prospective, multi-center, randomized study assessed the 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). Results were presented recently 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.
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 study result showed non inferiority of Resolute Onyx™ versus the comparator stent, BioFreedom™ drug coating stent – the only DES discussed by the European Society for Cardiology (ESC) in its guidelines for high bleeding risk patients that may need one-month DAPT.
Results also showed superior acute performance 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), repeat procedure, for Resolute Onyx™ versus 4.0% for the BioFreedom™. Additionally, stent thrombosis (ST) for Resolute Onyx™ was low (1.3%) versus BioFreedom™ (2.1%) and there was significantly lower myocardial infarction (MI) – 4.3% for Resolute Onyx™ versus 6.8% for BioFreedom™ (p < 0.01).
Craig Murphy, senior director, Medtronic Frontier Markets said, “High Bleeding Risk patients are a complex patient population often excluded from stent and drug trials, make up nearly 40% of all percutaneous coronary intervention (PCI) patients, and a potential group that could benefit from shorter DAPT treatment. Medtronic is committed to generating clinical evidence for the most complex patients and developing technologies and solutions that help anticipate, adapt and react to patient needs beyond the hospital setting.”
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.
To date, more than 20,000 patients have been studied in Medtronic clinical trials that have addressed DAPT duration. 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.
Professor, Dr. N A M Momenuzzaman from department of Cardiology , United Hospital, Dhaka shared his enthusiasm and explained the importance of the study stating, “In Bangladesh and all over the world, PCI patients (percutaneous coronary intervention) face high risk of bleeding and this Onyx ONE global study has generated significant advances in evidence for physicians determining the optimal duration of DAPT following PCI among high bleeding risk patients. Taking into consideration the huge and growing global coronary stent market, I believe the latest initiative by Medtronic is very well-timed.”
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.
