EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
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.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Støttrup Nicolaj Brejnholt, Christiansen Evald Høj, Raungaard Bent, Kahlert Johnny, Terkelsen Christian Juhl, Kristensen Steen Dalby, Thim Troels, Jakobsen Lars, Jensen Rebekka Vibjerg, Eftekhari Ashkan, Freeman Phillip, Jensen Svend Eggert, Veien Karsten Tange, Jensen Lisette Okkels, Maeng Michael, For Randomized Trials With Clinical Outcome Sort Out For The Scandinavian Organization
Аннотация
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.
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.