Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025
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.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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16 authors.
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Abstract
backgroundLong-term outcomes following implantation of drug-eluting coronary stents are necessary to determine safety and efficacy.
aimsWe 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).
methodsThis 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.
resultsWe 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).
conclusionsAt 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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