Choice of Stent Platforms in HBR Patients - Insights from the ONYX-ONE Trial

August 8th, Highlight Session of TCTAP & AP VALVES 2020 VIRTUAL

For a long time, a significant progress has been made to improve the ischemic outcomes after PCI with better stent platforms and more potent antiplatelet treatments, but the bleeding question emerged. It has become clear that MI is a bad thing to have, but major bleeding is certainly prognostically as important as MI. In addition to the effort to stratify patients with high ischemic versus bleeding risk and apply alternative antithrombotic strategies according to individual patient¡¯s risk profile, another major issue is what stent platform would be appropriate for high bleeding risk (HBR) patients.

Stephan Windecker, MD talks about the Choice of Stent Platforms in HBR Patients - Insights from the ONYX-ONE Trial at TCTAP & AP VALVES 2020 VIRTUAL

HBR patients are a complex population which consists of nearly one-fourth of patients receiving PCI, but with little evidence to support treatment decisions. The Onyx ONE trial adds to prior data from the LEADERS-FREE trial and suggests, in PCI patients with HBR, a durable polymer-based DES combined with 1-month dual antiplatelet therapy (DAPT) is non-inferior to a polymer-free drug-coated stent combined with the same DAPT regimen.

¡°The Onyx ONE trial was the first randomized trial comparing the new-generation Resolute Onyx zotarolimus-eluting stent with the BioFreedom polymer-free biolimus A9-coated stent¡± Dr. Windecker noted. The patients had to have at least one HBR criterion and routinely treated with one-month DAPT. The study was a global study carried out at 84 participating sites with a strong contribution also from the Asia-Pacific area.

Patients were elderly (mean age 74 years); approximately 40% in each group were diabetic, and 50% had an acute coronary syndrome. The most common HBR features were shown for those who are 75 years or older and the use of oral anticoagulants. By two months, 92% had transitioned to monotherapy consisting of aspirin in 55.9% and a P2Y12 inhibitor in 44.1%. At 12 months, 88% remained on a single antithrombotic therapy, which remained consistent throughout the year.

The study found that for the primary composite safety endpoint of cardiac death, myocardial infarction (MI), and definite/probable stent thrombosis at one year, the Resolute Onyx ZES was non-inferior to the drug-coated BioFreedom stent (17.1% vs. 16.9%; P for noninferiority = 0.011), with a risk difference of 0.2% and a one-sided upper-bound 95% CI of 3%. The cumulative incidence of the components of the primary endpoint showed no significant difference between the groups. Cardiac death was low and comparable in both groups (4.6% for Resolute Onyx vs 3.9% for BioFreedom; P = 0.40). Rates of definite/probable stent thrombosis were 1.5% with Resolute Onyx and 2.2% with BioFreedom (P = 0.21). But interestingly for MI that was similar in high rates related to the periprocedural MI, there was a significant difference for spontaneous MI in favor of the Resolute Onyx arm (4.6% vs. 7.1%, P=0.02). Accordingly, the landmark analysis set at 30-days, a time point with a majority of patients transitioned to a single antiplatelet therapy, there was no difference up to 30-days (9.9% vs. 8.7%, P=0.36) but lower incidence in favor of Resolute Onyx stent after 30-days (4.3% vs. 6.8%, P=0.01).

There was no difference between the stents for the combined secondary effectiveness endpoint of target-lesion failure at one year. Bleeding rates were high in both groups, but they were not statistically different for any BARC category.

Dr. Windecker summarized his talk by concluding among HBR patients treated with 1-month DAPT after PCI, Resolute Onyx was as safe and effective as Biofreedom.

¡°Although the LEADERS FREE and ONYX ONE trials used a 1-month DAPT strategy, I think we still don¡¯t know whether a 1-month duration of DAPT is optimal for these patients. The MASTER DAPT is ongoing and will probably provide more information¡± he emphasized.

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Editor: Se Hun Kang, MD (CHA Bundang Medical Center, CHA University)