There is a consistent number of patients presenting high risk of bleeding. In this context, receiving dual antiplatelet therapy (DAPT) for 12 months would not be advisable. Even though the European and American guidelines recommend 1 to 6 months for chronic and acute syndromes in this group, these are often complex PCI cases, which makes it a challenging decision.
The LEADRES FREE had shown the superiority of the BioFreedom -polymer free coated with Biolimus A9- over bare metal stents, but this has not been shown for the rest of stents.
As regards the Onyx, it was not inferior at 12 months, but it still hasn’t been tested beyond this period.
The ONYX ONE study randomized high bleeding risk patients (HBR) to receiving the Resolute Onyx (ZES), (with 81- to 91-um struts) vs. BioFreedom (DCS) polymer free (with 12 um s struts). Post PCI they received DAPT or DAPT plus anticoagulation during the first 30 days followed by SAPT (ASA or P2Y12 inhibitors) plus antibiotics, according to physician criterion.
It included 1003 patients receiving ZES and 933 DCS.
Safety primary end point was a composite of death, MI or definite or probable thrombosis at 12 months and effectiveness secondary end point was cardiac death, target vessel MI and ischemia driven revascularization at 12 months. They carried out a 2-year analysis.
Read also: Coronary Bifurcation Lesions: MRS or PCI? 10-Year Mortality of the SYNTAX Study.
There were no differences in the populations, mean age was 74, 33% were women, 38% diabetic, 10% smokers, 25% had prior MI, 30% prior CABG, 31% atrial fibrillation.
52% presented acute coronary syndrome.
DAPT discontinuation after 30 days was similar in both groups, 77% the second year (87% by the end of the first year), 65% receiving ASA as SAPT.
Read also: TRAPEUR Registry: Thrombus Trapping with Left Atrial Appendage Closure Device.
At 2-year followup, the primary end point for ZES and DCS was 21.2% vs. 20.7% (risk difference: 0.5%; 95% CI: -3.1%to 4.2%; P = 0.78), that is, there were no differences. The same happened for the secondary end point at 2 years: 22.1% vs. 21% (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P= 0.54) respectively.
Conclusion
Among patients with high bleeding risk treated with DAPT during 30 days and followed by SAPT, the Resolute ONYX ZES had similar evolution of safety and efficacy end points compared against the polymer free BioFreedom DCS.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients Final 2-Year Results From Onyx ONE.
Reference: Stephan Windecker, et al. J Am Coll Cardiol Intv 2022;15:1153–1163.
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