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Durable-polymer DES noninferior to polymer-free DCS in patients with high bleeding risk, shorter DAPT: Onyx ONE
SAN FRANCISCO — In the first randomized trial to compare a durable-polymer DES with a polymer-free drug-coated stent in patients with high bleeding risk who received 1 month of dual antiplatelet therapy, treatment with the DES was as safe and effective as treatment with the DCS, according to results of the Onyx ONE trial presented at TCT 2019.
Stephan Windecker, MD, professor and chairman of the department of cardiology at Bern University Hospital, University of Bern, presented results from 1,996 patients who were randomly assigned the durable-polymer zotarolimus-eluting stent (Resolute Onyx, Medtronic) or the polymer-free biolimus A9 DCS (BioFreedom, Biosensors Europe) and 1 month of DAPT, defined as aspirin and a P2Y12 inhibitor.
The ZES met the primary endpoint of cardiac death, MI or stent thrombosis at 1 year, showing noninferiority compared with the DCS. The primary endpoint occurred in 17.1% of patients assigned ZES vs. 16.9% assigned DCS (P for noninferiority = .011), Windecker said.
Onyx ONE was powered to assess a secondary effectiveness endpoint of target lesion failure, defined as cardiac death, target-vessel MI or clinically driven target lesion revascularization, at 1 year, which occurred in 18% of the ZES group vs. 17.9% of the DCS group (HR = 1.02; 95% CI, 0.83-1.26).
Bleeding Academic Research Consortium bleeding rates at 1 year were similar in both groups: BARC 1-5, 17.7% with ZES vs. 16.3% with DCS (P = .43); BARC 2-5, 15.1% vs. 13.7%, respectively (P = .4); and BARC 3-5, 4.9% vs. 4.4%, respectively (P = .67), Windecker said during a press conference.
A landmark analysis conducted after discontinuation of DAPT at 1 month showed low event rates. Between 1 month and 1 year, the composite endpoint of cardiac death, MI and stent thrombosis occurred in 7.5% of the ZES group vs. 8.8% of the DCS group. Additionally, there was significantly lower MI with the ZES during that period (4.3% vs. 6.8%; P < .01).
In other findings, more patients in the DCS group required crossover to an alternative stent (40 vs. 2; P < .001). Treatment with the ZES had greater improvement on angiographic outcomes, thus resulting in greater device success after PCI (92.8% vs. 89.7%; P = .007).
“These data demonstrate that Resolute Onyx is safe and effective in complex high-bleeding-risk patients who receive 1-month DAPT,” Windecker said.
The prospective, multicenter, single blind, randomized trial enrolled 2,000 patients at 84 sites worldwide. Baseline and lesion characteristics were similar among the groups. The mean age was 74 years, one-third were women, 38% had diabetes and about half presented with ACS. The primary lesion location was the left anterior descending artery, nearly 80% of lesions were B2/C class and the total stent length per patient was 37 mm.
After PCI, DAPT, including daily aspirin 75 mg to 100 mg and a P2Y12 inhibitor, was prescribed for 1 month. While clopidogrel was preferred, other therapies were allowed. Patients on oral anticoagulation could receive single- or dual therapy during the first month following PCI. After 1 month, single antiplatelet therapy, with aspirin or a P2Y12 inhibitor, was prescribed at the physician’s discretion. At 1 year, 88% of patients were on single antiplatelet therapy, with 56.8% taking only aspirin and 43.2% only a P2Y12 inhibitor, according to Windecker.
Commenting on the results during the press conference, Marco Valgimigli, MD, associate professor of cardiology and senior interventional cardiologist at Inselspital Universitätsspital Bern, Switzerland, said it’s important to note that this study compared two devices, rather than comparing DAPT durations.
“I don’t think this study gives us the confidence that 1-month DAPT is the optimal DAPT duration in this specific patient population.” Rather, he said, “this study answers another question, namely, when and if the clinician has decided that 1-month DAPT is the way to go, I think this study, for the very first time, allows us to know that [the Resolute] Onyx stent is a viable and reasonable option.” – by Katie Kalvaitis
Reference:
Windecker S, et al. Late-Breaking Trials 1. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosures: The Onyx ONE study was funded by Medtronic. Windecker reports research grants to his institution from Abbott, Amgen, Bayer, Biotronik, Boston Scientific, Bristol-Myers Squibb, CSL Behring, Edwards Lifesciences, Medtronic, Polares and Sinomed.
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There was a lot of excitement after the LEADERS FREE trial of the BioFreedom DCS for high-bleeding-risk patients, but that is a stent that was not available in the U.S. To now see that with a state-of-the-art DES you can do very short-term DAPT is important data for the high-bleeding-risk population, which comprises a significant patient subgroup. Onyx ONE shows very reassuring data. However, a lot of questions remain, such as which DAPT and greater refinement of knowing who are the high-bleeding-risk patients. Still, Onyx ONE was a very well-conducted study.