Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents in BIONYX at 2 Years.
OBJECTIVES
The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.


BACKGROUND
The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.


METHODS
A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.


RESULTS
Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]).


CONCLUSIONS
At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.
['Buiten|Rosaly A|RA|', 'Ploumen|Eline H|EH|', 'Zocca|Paolo|P|', 'Doggen|Carine J M|CJM|', 'Jessurun|Gillian A J|GAJ|', 'Schotborgh|Carl E|CE|', 'Roguin|Ariel|A|', 'Danse|Peter W|PW|', 'Benit|Edouard|E|', 'Aminian|Adel|A|', 'van Houwelingen|K Gert|KG|', 'Schramm|Alexander R|AR|', 'Stoel|Martin G|MG|', 'Somi|Samer|S|', 'Hartmann|Marc|M|', 'Linssen|Gerard C M|GCM|', 'von Birgelen|Clemens|C|']
D000368:Aged D001530:Belgium D002317:Cardiovascular Agents D003324:Coronary Artery Disease D003328:Coronary Thrombosis D054855:Drug-Eluting Stents D005260:Female D006801:Humans D007557:Israel D008297:Male D008875:Middle Aged D009426:Netherlands D062645:Percutaneous Coronary Intervention D011446:Prospective Studies D011474:Prosthesis Design D020123:Sirolimus D013997:Time Factors D016896:Treatment Outcome
clinical trial drug-eluting stents percutaneous coronary intervention