Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial
Authors: Valgimigli Marco , Wlodarczak Adrian , Tölg Ralph , Merkely Béla , Kelbæk Henning , Legutko Jacek , Galli Stefano , Godin Matthieu , Toth Gabor G. , Lhermusier Thibault , Honton Benjamin , Dietrich Peter Laurenz , Stammen Francis , Ferdinande Bert , Silvain Johanne , Capodanno Davide , Cayla Guillaume , Valgimigli Marco , Wlodarczak Adrian , Tölg Ralph , Merkely Béla , Moccetti Marco , Kelbæk Henning , Legutko Jacek , Galli Stefano , Godin Matthieu , Toth-Gayor Gabor G. , Lhermusier Thibault , Honton Benjamin , Sanguineti Francesca , Dietrich Peter Laurenz , Stammen Francis , Ferdinande Bert , Silvain Johanne , Capodanno Davide , Birkemeyer Ralf , Schneider Steffen , Büllesfeld Lutz , Witzenbichler Bernhard , Hochadel Matthias , Collins Nicolas , Shiekh Imran , Van Gaal William , Brandt Mathias-Christoph , Kefer Joëlle , Coussement Patrick , Olsen Niels Thue , Cayla Guillaume , Puymirat Etienne , Lemesle Gilles , Romain Didier , Haude Michael , Schmitz Thomas , Sherif Mohammad , Wöhrle Jochen , Arthur Yung See Yue , Yan Bryan , Vorobcsuk András , Horvath Ivan , Ferlini Marco , Nicolini Elisa , Erglis Andrejs , Kalnins Artis , Azmi Shaiful , Somi Samer , Somaratne Jithendra , Zhi Lin Deanna Khoo , de la Torre Hernandez Jose Maria , Bosco Alfonso Torres , Fores Juan Sanchis , Fournier Stéphane , Iglesias Juan , Rubimbura Vladimir , Kehasukcharoen Wirash 
Published: August 2023

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.