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BIONYX Trial: Resolute Onyx vs. Orsiro DES in All-Comers With CAD
Study Questions:
What is the safety and efficacy of the Resolute Onyx stent compared with the Orsiro stent, which consists of ultrathin cobalt–chromium struts?
Methods:
The BIONYX trial investigators conducted an investigator-initiated, assessor-blinded and patient-blinded, randomized noninferiority trial in an all-comers population at seven independently monitored centers in Belgium, Israel, and the Netherlands. Eligible participants were aged ≥18 years and required percutaneous coronary intervention with drug-eluting stents. After guide wire passage with or without predilation, members of the catheterization laboratory team used web-based computer-generated allocation sequences to randomly assign patients (1:1) to either the Resolute Onyx or the Orsiro stent. Randomization was stratified by sex and diabetes status. Patients and assessors were masked to allocated stents, but treating clinicians were not. The primary endpoint was target vessel failure at 1 year, a composite of cardiac death, target-vessel-related myocardial infarction, and target vessel revascularization, and was assessed by intention to treat (noninferiority margin 2.5%) on the basis of outcomes adjudicated by an independent event committee. Time to endpoints was assessed by the Kaplan-Meier method; the log-rank test was applied for between-group comparisons.
Results:
Between October 7, 2015, and December 23, 2016, 2,516 patients were enrolled, 2,488 of whom were included in the intention-to-treat analysis (28 withdrawals or screening failures). A total of 1,243 participants were assigned to the Resolute Onyx group, and 1,245 to the Orsiro group. Overall, 1,765 (70.9%) participants presented with acute coronary syndromes and 1,275 (51.2%) had myocardial infarctions. One-year follow-up was available for 2,478 (99.6%) patients. The primary endpoint was met by 55 (4.5%) patients in the Resolute Onyx group and 58 (4.7%) in the Orsiro group. Noninferiority of Resolute Onyx to Orsiro was thus established (absolute risk difference, –0.2%; 95% confidence interval [CI], –1.9 to 1.4; upper limit of the one-sided 95% CI, 1.1%; p for noninferiority = 0.0005). Definite or probable stent thrombosis occurred in one (0.1%) participant in the Resolute Onyx group and nine (0.7%) in the Orsiro group (hazard ratio, 0.11; 95% CI, 0.01–0.87; p = 0.0112).
Conclusions:
The authors concluded that the Resolute Onyx stent was noninferior to Orsiro for a combined safety and efficacy endpoint at 1-year follow-up in all-comers.
Perspective:
This study reports that the Resolute Onyx stent and the Orsiro stent were equally effective and safe, with excellent 1-year clinical outcomes in an all-comers population. The rates of the individual components of the primary endpoint were similar and quite low in both groups, which may reflect safety of both devices. Although the frequency of stent thrombosis was low in both groups, the risk was particularly low in the Resolute Onyx group, despite complexity of the trial participants with a high proportion of acute coronary syndrome patients, and may make this stent particularly attractive.
Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Acute Coronary Syndrome, Catheterization, Coronary Artery Disease, Diabetes Mellitus, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Thrombosis
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