{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,22]],"date-time":"2026-03-22T04:22:19Z","timestamp":1774153339014,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,5,27]],"date-time":"2021-05-27T00:00:00Z","timestamp":1622073600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Cardiology"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The RE\u2010DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y<jats:sub>12<\/jats:sub> inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y<jats:sub>12<\/jats:sub> inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI.<\/jats:p><\/jats:sec><jats:sec><jats:title>Hypothesis<\/jats:title><jats:p>The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y<jats:sub>12<\/jats:sub> inhibitor in comparison to triple therapy with warfarin, a P2Y<jats:sub>12<\/jats:sub> inhibitor and aspirin is consistent in females and males.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non\u2010major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110\u2009mg dual therapy and dabigatran 150\u2009mg dual therapy compared with warfarin triple therapy in female and male patients (for 110\u2009mg: females: HR 0.69, 95% CI 0.47\u20131.01, males: HR 0.46, 95% CI 0.37\u20130.59, interaction p value: 0.084 and for 150\u2009mg: females HR 0.74, 95% CI 0.48\u20131.16, males HR 0.71, 95% CI 0.56\u20130.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110\u2009mg and 150\u2009mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.<\/jats:p><\/jats:sec>","DOI":"10.1002\/clc.23649","type":"journal-article","created":{"date-parts":[[2021,5,27]],"date-time":"2021-05-27T11:39:28Z","timestamp":1622115568000},"page":"1002-1010","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The effect of sex on the efficacy and safety of dual antithrombotic therapy with dabigatran versus triple therapy with warfarin after <scp>PCI<\/scp> in patients with atrial fibrillation (a <scp>RE\u2010DUAL PCI<\/scp> subgroup analysis and comparison to other dual antithrombotic therapy trials)"],"prefix":"10.1002","volume":"44","author":[{"given":"David S.","family":"Eccleston","sequence":"first","affiliation":[{"name":"Department of Medicine University of Melbourne and GenesisCare  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6017-6871","authenticated-orcid":false,"given":"Joseph M.","family":"Kim","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jurien M.","family":"ten Berg","sequence":"additional","affiliation":[{"name":"Department of Cardiology St. Antonius Ziekenhuis  Nieuwegein Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6896-2941","authenticated-orcid":false,"given":"P. Gabriel","family":"Steg","sequence":"additional","affiliation":[{"name":"FACT, an F\u2010CRIN Network, DHU FIRE Universit\u00e9 Paris Diderot, INSERM U_1148 and H\u00f4pital Bichat Assistance Publique  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deepak L.","family":"Bhatt","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan H.","family":"Hohnloser","sequence":"additional","affiliation":[{"name":"Johann Wolfgang Goethe University Department of Cardiology, Division of Clinical Electrophysiology  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"de Veer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matias","family":"Nordaby","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim GmbH  Ingelheim Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corinna","family":"Miede","sequence":"additional","affiliation":[{"name":"Mainanalytics GmbH  Sulzbach (Taunus) Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Kimura","sequence":"additional","affiliation":[{"name":"Kyoto University Department of Cardiovascular Medicine  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7566-1626","authenticated-orcid":false,"given":"Gregory Y. H.","family":"Lip","sequence":"additional","affiliation":[{"name":"Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart &amp; Chest Hospital  Liverpool UK"},{"name":"Department of Clinical Medicine, Aalborg Thrombosis Research Unit Aalborg University  Aalborg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Oldgren","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences and Uppsala Clinical Research Center Uppsala University  Uppsala Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4596-2791","authenticated-orcid":false,"given":"Christopher P.","family":"Cannon","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,5,27]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.114.001398"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2020.0359"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00684-X"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.11.055"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2004.05.045"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.05.074"},{"issue":"7862","key":"e_1_2_9_8_1","first-page":"1","article-title":"Assessment of female sex as a risk factor in atrial fibrillation in Sweden: Nationwide retrospective cohort study","volume":"344","author":"Friberg L","year":"2012","journal-title":"BMJ"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2018.07.044"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.04.066"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.117.005801"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1708454"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.22572"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)62177-1"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611594"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31872-0"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1817083"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2007.02.027"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.002683"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000048895.18974.6B"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.09.065"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz898"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.108290"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.116.015900"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.029081"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/clc.23257"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2019-315065"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11886-009-0080-2"}],"container-title":["Clinical Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.23649","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/clc.23649","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.23649","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T14:40:17Z","timestamp":1693406417000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/clc.23649"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,27]]},"references-count":27,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1002\/clc.23649"],"URL":"https:\/\/doi.org\/10.1002\/clc.23649","archive":["Portico"],"relation":{},"ISSN":["0160-9289","1932-8737"],"issn-type":[{"value":"0160-9289","type":"print"},{"value":"1932-8737","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5,27]]},"assertion":[{"value":"2021-02-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-05-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-05-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}