Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial
Marco Valgimigli, Adrian Włodarczak, Ralph Tölg, Béla Merkely, Henning Kelbæk, Jacek Legutko, Stefano Galli, Matthieu Godin, Gábor G. Tóth, Thibault Lhermusier, Benjamin Honton, Peter Laurenz Dietrich, Francis Stammen, Bert Ferdinande, Johanne Silvain, Davide Capodanno, Guillaume Cayla, Marco Valgimigli, Adrian Włodarczak, Ralph Tölg, Béla Merkely, Marco Moccetti, Henning Kelbæk, Jacek Legutko, Stefano Galli, Matthieu Godin, Gábor Tóth-Gayor, Thibault Lhermusier, Benjamin Honton, Francesca Sanguineti, Peter Laurenz Dietrich, Francis Stammen, Bert Ferdinande, Johanne Silvain, Davide Capodanno, Ralf Birkemeyer, Steffen Schneider, Lutz Büllesfeld, Bernhard Witzenbichler, Matthias Hochadel, Nicolas Collins, I. Shiekh, W. van Gaal, Mathias C. Brandt, Joëlle Kefer, Patrick Coussement, Niels Thue Olsen, Guillaume Cayla, Étienne Puymirat, Gilles Lemesle, Romain Didier, Michael Haude, Thomas Schmitz, Mohammad Sherif, Jochen Wöhrle, See Yue Arthur Yung, Bryan Yan, András Vorobcsuk, Iván Horváth, Marco Ferlini, Elisa Nicolini, Andrejs Ērglis, Artis Kalniņš, Shaiful Azmi, Samer Somi, J. Somaratne, Deanna Khoo Zhi Lin, José M. de la Torre Hernández, Alfonso Torres Bosco, Juan Sanchis Fores, Stéphane Fournier, Juan Eugenio Iglesias, Vladimir Rubimbura, Wirash Kehasukcharoen
Abstract
BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P <0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04137510.