Original Research

DOI: 10.4244/EIJ-D-24-00763

Everolimus-eluting versus biolimus-eluting stents with biodegradable polymers in unselected patients undergoing percutaneous coronary intervention: five-year results of the randomised, non-inferiority SORT OUT VIII trial

Nicolaj Brejnholt Støttrup1,2, MD, PhD; Evald Høj Christiansen1,2, MD, PhD; Bent Raungaard3, MD, PhD; Johnny Kahlert4, PhD; Christian Juhl Terkelsen1,2, MD, DMSc; Steen Dalby Kristensen1,2, MD, DMSc; Troels Thim1,2, MD, PhD; Lars Jakobsen1, MD, PhD; Rebekka Vibjerg Jensen1,2, MD, PhD; Ashkan Eftekhari3, MD, PhD; Phillip Freeman3, MD; Svend Eggert Jensen3, MD, PhD; Karsten Tange Veien1,5, MD; Lisette Okkels Jensen5, MD, DMSc; Michael Maeng1,2, MD, PhD; for the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT)

Abstract

Background: Long-term outcomes following implantation of drug-eluting coronary stents are necessary to determine safety and efficacy.

Aims: We aimed to report the 5-year outcomes of the SYNERGY thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) versus the BioMatrix NeoFlex biodegradable-polymer biolimus-eluting stainless-steel stent (BES).

Methods: This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites in Western Denmark. Patients with a clinical indication for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. Outcomes included target lesion failure (TLF: cardiac death, myocardial infarction not clearly attributable to a non-target lesion, or target lesion revascularisation), all myocardial infarctions, and very late stent thrombosis at 5-year follow-up.

Results: We included 2,764 patients and randomly assigned 1,385 patients to treatment with EES and 1,379 patients to treatment with BES. TLF occurred in 150 patients (10.8%) assigned to the EES and in 165 (12.0%) assigned to the BES (rate ratio [RR] 0.88, 95% confidence interval [CI]: 0.71-1.10). The incidence of myocardial infarction was lower in the EES group (EES: n=85 [6.1%], BES: n=116 [8.4%]; RR 0.71, 95% CI: 0.54-0.95), while very late stent thrombosis was rare for both stent types (EES: n=12 [0.9%], BES: n=9 [0.7%]; RR 1.32, 95% CI: 0.56-3.14).

Conclusions: At 5-year follow-up, TLF was comparable for EES and BES. The incidence of myocardial infarction, however, was lower in patients randomised to EES versus BES implantation.

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Volume 21 Number 11
Jun 2, 2025
Volume 21 Number 11
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