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Antithrombotic trials provide a relevant case, as bleeding-related discontinuation is common and more often occur in patients at increased risk also for ischaemic events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>We reviewed large antithrombotic RCTs published in The New England Journal of Medicine (2020\u20132025) to assess reporting and analytic handling of treatment discontinuation. We also conducted simulations to examine how discontinuation patterns influence efficacy estimates under three scenarios: discontinuation only in the treatment arm, in both arms with similar patterns, and in both arms but outcome-associated only in the treatment arm. Treatment policy (intention-to-treat) and while-on-treatment strategies were compared within the ICH E9(R1) framework. Among fourteen reviewed antithrombotic RCTs, about one-third of patients discontinued treatment in trials with more than 6 months follow-up, with higher imbalance in open-label studies. Over half of discontinuations were safety-related, yet timing and temporary interruptions were rarely reported. Most reported both ITT and per-protocol (PP) analyses, with PP assuming non-informative censoring and yielding larger efficacy estimates. In simulations, treatment policy and while-on-treatment strategies were biased when discontinuation was outcome-associated, while Simon\u2013Makuch curves helped identify prognostic discontinuation differing by treatment arm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Discontinuation is common, prognostically meaningful, and often oversimplified in analysis, threatening the validity of RCT findings. Explicitly addressing discontinuation as an intercurrent event within the estimand framework, along with stratified outcome curves, can improve interpretation and support more robust trial conclusions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ehjqcco\/qcag084","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T11:34:02Z","timestamp":1779190442000},"page":"1011-1022","source":"Crossref","is-referenced-by-count":1,"title":["Potential bias in efficacy estimates due to intercurrent treatment discontinuations"],"prefix":"10.1093","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4155-4451","authenticated-orcid":false,"given":"Bjorn","family":"Redfors","sequence":"first","affiliation":[{"name":"Department of Population Health Sciences, Weill Cornell Medicine , 425 East 61st Street, NewYork, NY 10065 ,","place":["USA"]},{"name":"Department of Molecular and Clinical Medicine, Gothenburg University , Bruna Str\u00e5ket 16, 413 45 Gothenburg ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4616-4257","authenticated-orcid":false,"given":"Jacky","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, Weill Cornell Medicine , 425 East 61st Street, NewYork, NY 10065 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4680-0815","authenticated-orcid":false,"given":"Mario","family":"Gaudino","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Weill Cornell Medicine , 525 East 68th Street, NewYork, NY 10065 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0284-0655","authenticated-orcid":false,"given":"Harmony R","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Leon H. 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