September 27, 2019
Onyx ONE Study Evaluates 1-Month DAPT in High-Bleeding Risk Patients
September 26, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the Onyx One study were presented by Stephan Windecker, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.
The randomized Onyx ONE study compared a durable polymer-based, drug-eluting stent (DES; Resolute Onyx zotarolimus-eluting coronary stent system; Medtronic) with a polymer-free, drug-coated stent (DCS; BioFreedom BA9 drug-coated coronary stent; Biosensors International Group, Ltd.) in patients at high bleeding risk (HBR) and treated with 1-month dual antiplatelet therapy (DAPT) (aspirin and an oral P2Y12 inhibitor). The investigators found that both are clinically safe and effective.
According to CRF, the background of the study is that current guidelines recommend 3 to 6 months of DAPT for HBR patients undergoing percutaneous coronary intervention (PCI) with consideration for DAPT duration as short as 1 month in selected patients. Up to 40% of patients undergoing PCI have HBR characteristics. However, there are few randomized data with shorter durations of DAPT, especially for current-generation polymer-based DES.
The prospective, multicenter, single-blind randomized trial enrolled 2,000 HBR patients who were randomized 1:1 at 84 global sites. The primary safety endpoint was cardiac death, myocardial infarction (MI), or definite/probable stent thrombosis at 1 year. The powered secondary endpoint was target lesion failure, a composite of cardiac death, target vessel MI, or clinically driven target lesion revascularization. Other secondary endpoints included device and procedure success rates, Bleeding Academic Research Consortium bleeding, and the individual components of the primary endpoints.
Dr. Windecker reported that of the 1,996 patients randomized, 1-year follow-up was available in 98.5% (n = 988) of the DES arm and 97.6% (n = 969) of the DCS arm. Baseline and lesion characteristics were similar among both groups. Crossover to an alternative stent occurred more frequently in the DCS arm (40 vs 2; P < .001).
The investigators found the following:
- The DES compared with the DCS showed improved angiographic outcomes resulting in greater device success after PCI (92.8% vs 89.7%; P = .007). At 2 months after PCI, 92% of patients were on single antiplatelet therapy; at 1 year, 88% were on single antiplatelet therapy.
- The primary safety endpoint of cardiac death, MI, or definite/probable stent thrombosis at 1 year was 17.1% for DES and 16.9% for DCS (Pnoninferiority = .011).
- The powered secondary effectiveness endpoint of target lesion failure at 1 year was 18.0% for DES and 17.9% for DCS (hazard ratio, 1.02; 95% confidence interval, 0.83–1.26; P = .84). Bleeding rates were also similar among both treatment groups.
Dr. Windecker commented in the CRF announcement, “The Onyx ONE global randomized trial is the first study to evaluate outcomes between a polymer-based DES and a polymer-free DCS with 1-month DAPT after PCI in a complex patient population. The data shows that the polymer-based zotarolimus-eluting stent is as safe and effective as the polymer-free drug-coated stent in HBR patients treated with 1-month DAPT and provides important evidence to inform clinical decision-making for high-bleeding-risk patients.”