In late-breaking clinical data, Medtronic showed that its Resolute Onyx drug-eluting stent showed success in patients at a high risk for bleeding, a group that is often excluded from stent and drug studies.
The trial enrolled and randomized nearly 2,000 participants with one month of dual antiplatelet therapy. Medtronic estimates that patients with high bleeding risk account for nearly 40% of all percutaneous coronary interventions, or PCIs.
The study compared Resolute Onyx with the BioFreedom DCS drug-eluting stent developed by Biosensors International. BioFreedom, not approved for use in the U.S., is currently listed as the stent of choice in guidelines from the European Society for Cardiology for patients that cannot tolerate long regimens of antiplatelet therapy due to bleeding safety concerns.
The results—presented at the Cardiovascular Research Foundation’s TCT conference in San Francisco—showed that Medtronic’s stent met its primary endpoint of non-inferiority after one year, across measures of cardiac death, heart attack or stent thrombosis.
“With a growing proportion of PCI patients at a high risk of bleeding, we knew it was critical to generate randomized clinical evidence to evaluate outcomes in this under-represented patient population at increased risk for adverse outcomes,” said study principal investigator Stephan Windecker, of Bern University Hospital in Switzerland.
“This study provides important advances in evidence for physicians determining the optimal duration of DAPT following PCI among high bleeding risk patients,” Windecker added. “Data like these are very informative for clinical practice.”
Additionally, the Resolute Onyx stent showed superior device success rates, of 92.8% compared to BioFreedom’s 89.7%, and rates of target lesion revascularization and stent thrombosis were lower, at 2.8% compared to 4.0% and 1.3% versus 2.1%, respectively.
“With these new data presented today, the evidence provides greater confidence in treating complex patients with Resolute Onyx and a shortened course of DAPT,” said Dave Moeller, VP and general manager of Medtronic’s Coronary and Renal Denervation business. Resolute Onyx previously received a CE Mark in 2014 and FDA approval in 2017.
Patients at high bleeding risk must often manage anticoagulant use, renal failure, upcoming surgery and recent blood transfusions. The study protocol did not exclude patients based on disease state or anatomical complexity, Medtronic said.