First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial

Eline Hubertina Ploumen, Rosaly Anne Buiten, Paolo Zocca, Carine Doggen, Adel Aminian, Carl E. Schotborgh, Gillian A.J. Jessurun, Ariel Roguin, Peter W. Danse, Edouard Benit, Clemens von Birgelen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background:At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years.

Methods and Results:We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 [9.2%] vs. O-SES 109/1,245 [8.9%], hazard ratio [HR]: 1.03, 95% confidence interval [CI] 0.79–1.34; Plog-rank=0.85) and its individual components. The all-cause mortality was significantly lower after PCI with RO-ZES (3.7% vs.5.4%, HR: 0.67, 95% CI 0.46–0.97; Plog-rank=0.034), but cardiac mortality did not differ significantly (1.1% vs.1.9%, HR: 0.56, 95% CI 0.28–1.11; Plog-rank=0.09). Definite-or-probable stent thrombosis rates were low for both groups (0.6% vs.1.2%, HR: 0.46, 95% CI 0.19–1.14; Plog-rank=0.09).

Conclusions:This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest.
Original languageEnglish
JournalCirculation Journal
DOIs
Publication statusE-pub ahead of print/First online - 13 Jul 2021

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