EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2026
Percutaneous coronary intervention using sirolimus-eluting balloons in patients at high bleeding risk: the SELUTION DeNovo HBR substudy.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Rissanen Tuomas T, Eccleshall Simon, Krackhardt Florian, Bogaerts Kris, Akiki Tanios, Briguori Carlo, Cayla Guillaume, Cruden Nick, den Hartog Alexander W, Garot Philippe, Häner Jonas, Iglesias Juan F, Jiménez Victor, Johnson Thomas W, Langer Christoph, Meunier Ludovic, Poustis Pierre, Ratib Karim, Sabaté Manel, Secco Gioel, Toth Gabor G, Watkins Stuart, Wiemer Marcus, Wykrzykowska Joanna, Spaulding Christian, Urban Philip, Selution DeNovo Investigators On Behalf Of The
Аннотация
BACKGROUND: Drug-eluting stents (DES) are the current mainstay of percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients. However, drug-coated balloons may be an alternative that reduces reliance on prolonged courses of antiplatelet therapy.
AIMS: The SELUTION DeNovo trial randomised 3,323 PCI candidates 1:1 to treatment with either sirolimus-eluting balloons (SEBs) and provisional stenting or systematic DES implantation. We report on a prespecified subgroup of HBR patients.
METHODS: A total of 522 enrolled patients met the Academic Research Consortium-HBR criteria. At 1 year, we assessed target vessel failure (TVF; a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation), major bleeding (Bleeding Academic Research Consortium [BARC] 3-5) and net adverse clinical events (NACE; a composite of TVF and BARC 3-5 bleeding). Antithrombotic treatment was prescribed according to current guidelines and local practice.
RESULTS: Altogether, 269 and 253 patients were identified as HBR in the SEB strategy and DES strategy arms, respectively. In the SEB arm, 17.1% of patients had bailout stenting. Overall, 67% of patients were discharged on oral anticoagulants. At 1 year, TVF occurred in 4.9% of the SEB arm vs 7.9% of the DES arm (absolute risk difference [RD] -3.05%, 95% confidence interval [CI]: -7.27 to 1.17). BARC 3-5 bleeding occurred in 2.3% vs 3.2% (absolute RD -0.91%, 95% CI: -3.71 to 1.89) and NACE in 6.8% vs 10.7% (absolute RD -3.94%, 95% CI: -8.80 to 0.92) in the SEB and DES arms, respectively. While the proportion of patients on dual antiplatelet therapy and single antiplatelet therapy did not differ significantly between the two groups during follow-up, all antiplatelet medication was stopped in 7.7% vs 2.5% at 30 days (p=0.005) and in 27.8% vs 14.9% of patients at 6 months (p<0.001) in the SEB and DES arms, respectively.
CONCLUSIONS: Although this subset analysis is not powered for definitive conclusions, our data suggest that an SEB strategy with minimal stenting appears to be a safe and effective alternative to systematic DES implantation for HBR patients.
AIMS: The SELUTION DeNovo trial randomised 3,323 PCI candidates 1:1 to treatment with either sirolimus-eluting balloons (SEBs) and provisional stenting or systematic DES implantation. We report on a prespecified subgroup of HBR patients.
METHODS: A total of 522 enrolled patients met the Academic Research Consortium-HBR criteria. At 1 year, we assessed target vessel failure (TVF; a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation), major bleeding (Bleeding Academic Research Consortium [BARC] 3-5) and net adverse clinical events (NACE; a composite of TVF and BARC 3-5 bleeding). Antithrombotic treatment was prescribed according to current guidelines and local practice.
RESULTS: Altogether, 269 and 253 patients were identified as HBR in the SEB strategy and DES strategy arms, respectively. In the SEB arm, 17.1% of patients had bailout stenting. Overall, 67% of patients were discharged on oral anticoagulants. At 1 year, TVF occurred in 4.9% of the SEB arm vs 7.9% of the DES arm (absolute risk difference [RD] -3.05%, 95% confidence interval [CI]: -7.27 to 1.17). BARC 3-5 bleeding occurred in 2.3% vs 3.2% (absolute RD -0.91%, 95% CI: -3.71 to 1.89) and NACE in 6.8% vs 10.7% (absolute RD -3.94%, 95% CI: -8.80 to 0.92) in the SEB and DES arms, respectively. While the proportion of patients on dual antiplatelet therapy and single antiplatelet therapy did not differ significantly between the two groups during follow-up, all antiplatelet medication was stopped in 7.7% vs 2.5% at 30 days (p=0.005) and in 27.8% vs 14.9% of patients at 6 months (p<0.001) in the SEB and DES arms, respectively.
CONCLUSIONS: Although this subset analysis is not powered for definitive conclusions, our data suggest that an SEB strategy with minimal stenting appears to be a safe and effective alternative to systematic DES implantation for HBR patients.