Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk
Authors: Landi Antonio , Alasnag Mirvat , Heg Dik , Frigoli Enrico , Malik Fazila Tun Nesa , Gomez-Blazquez Ivan , Pourbaix Suzanne , Chieffo Alaide , Spaulding Christian , Sainz Fermin , Routledge Helen , Andò Giuseppe , Testa Luca , Sciahbasi Alessandro , Contractor Hussain , Jepson Nigel , Mieres Juan , Imran Syed Saqib , Noor Husam , Smits Pieter C. , Valgimigli Marco ,   MASTER DAPT Investigators, Valgimigli Marco , Smits Peter C. , Van Es G.A. , Vos G.B.W.E. , Spitzer E. , Vrancks Pascal , Chevalier Bernard , Ozaki Yukio , Morice Marie-Claude , Windecker Stephan , Onuma  Yoshinobu , Frigoli Enrico , Frenk Andrè , Jüni Peter C. , Tijssen Jan , Paunovic D. , Ajit Mullasari S. , Alasnag Mirvat , Bartunek Jozef , Colombo Antonio , Hildick-Smith David , Iñiguez Andrés , Mahfoud Felix , Kornowski Ran , Lesiak Maciej , Ong Paul J.L. , Rodriguez Alfredo E. , Roffi Marco , Schultz Carl , Stankovic Goran , Tonino Pim , Moschovitis Aris , Laanmets Peep , Donahue Michael , Bertrand M. , Pocock Stuart , Urban Philip , Leonardi Sergio , Hanet Claude , Lopes Renato , McFadden Eùgene P. , Radke Peter , Roine Risto O. , Ladan Boudijn , van der Waal Laura , Engelbrecht Yvonne , Paddenburg Fred , Ren Ben , de Zwart Ingrid , Elshout Liliane , Jonk Judith , Rademaker-Havinga Tessa , van Vliet Ria , Krishna Kondamudi Phani , Morsiani Laure , Windhövel Ute , van der Wal Anita , Bakker Chantal , Minagawa Kazuhiro , Mieres Juan , Cura Fernando , Fernandez-Pereira Carlos , Lee Astin , Jepson Nigel , Whitbourn Robert , Christopher Raffel Owen , Huber Kurt , Weidinger Franz , Malik Hasselt Fazila-Tun-Nesa , Ziekenhuis Jessa , Ziekenhuis Imelda , Dewilde Willem , Aminian Adel , Aalst Emanuele , Pourbaix Suzanne , Xaplanteris Panagiotis , Velchev Vasil , Karageorgiev Dimitar , Mateev Hristo , Gelev Valeri , Kala Petr , Mates Martin , Kelbæk Henning , Hovasse Thomas , Delorme Laurent , Cuisset Thomas , Belle Loïc , Beygui Farzin , Piot Christophe , Morelle Jean François , Koning Rene , Valla Mathieu , Brunel Philippe , Cayla Guillaume , Teiger Emmanuel , Montalescot Gilles , Spaulding Christian , Guyon Phillipe , Stylianos Pyxaras , Merkely Bela , Ungi Imre , Abhaichand Rajpal K , Abhyankar Atul Damodar , Sengottuvelu Gunasekaran , Majdi Halabi , Roguin Ariel , Feld Yair , Lotan Chaim , Garducci Stefano , Reimers Bernhard , Sardella Gennaro , Milan Antonio , Chieffo Alaide , Tamburino Corrado , Andò Giuseppe , Testa Luca , Di Biasi Maurizio , Sciahbasi Alessandro , Calabro Paolo , Minervini Gianluigi , Loi Bruno , Fabbiocchi Franco , Oreglia Jacopo , Sganzerla Paolo , Ando Kenji , Higuchi Yoshiharu , Nanasato Mamoru , Ishibashi Yuki , Matsuo Hitoshi , Yoshida Ruka , Shimizu Kiyokazu , Kamiya Haruo , Komiyama Nobuyuki , Amano Tetsuya , Murohara Toyoaki , Yamazaki Seiji , Noor Husam , Kedev Sasko , Podolec Jakub , Reszuch Krzysztof , Wlodarczak Adrian , Dudek Dariusz , Canas da Silva Pedro , Mangovski Ljupco , Topic Dragan , Debeijacki Dragan , Ong Jau Lueng Paul , Saqib Imran Syed , Seung-Jung Park , Diaz Fernandez Jose Francisco , Garcia Del Blanco Brudo , Mainar Vicente , Gómez-Blázquez Iván , Pinar Eduardo , Escaned Barbosa Javier , Antoni Joan , Sainz Fermin , Goicolea Javier , Fröbert Ole , Kastberg Robert , Leibundgut Gregor , Pedrazzini Giovanni , Garachemani Ali , Siegrist Patrick , Cook Stephane , Mafragi Al , Jessurun Gillian Aj , Ruifrok Willem Theodoor , Danse Peter , Polad Jawed , Kauer Floris , von Birgelen Clemens , Ten Berg Jurrien , Ijsselmuiden Sander , Somi Samer , Johnson Tom , Routledge Helen , Din Jehangir , Munir Shahzad , McDonald John , Kikreja Neville , Mamas Mamas , Das Rajiv , Contractor Hussain , Peace Aaron , Williams Rupert , Ngoc Quang Nguyen 
Published: November 2023

ImportanceAbbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).ObjectivesTo evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR.Design, Setting, and PatientsThis prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022.InterventionsAbbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups.Main Outcomes and MeasuresOne-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB).ResultsOf the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI.Conclusions and RelevanceThese findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events.Trial RegistrationClinicalTrials.gov Identifier: NCT03023020