{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:55:05Z","timestamp":1787018105921,"version":"build-2736575974"},"reference-count":40,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,2,20]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Congenital heart disease (CHD) is common in children and associated with greater risk of thrombotic complications. Management of these complications with standard\u2010of\u2010care treatment is suboptimal for these children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods and Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      The effectiveness and safety of dabigatran were demonstrated in pivotal pediatric studies for the treatment of acute venous thromboembolism (VTE; NCT01895777) and secondary VTE prevention (NCT02197416). We report safety and efficacy outcomes from subgroup analyses of these studies for children with CHD (diagnosed according to local practice) and those without. In NCT01895777, 17\/21 (81.0%) and 16\/27 (59.3%) patients with CHD (including cyanotic) treated with dabigatran and standard of care, respectively, met the primary end point (complete thrombus resolution, freedom from recurrent VTE, and freedom from VTE\u2010related death; odds ratio [OR], 0.34 [95% CI, 0.08\u20131.23]). In patients without CHD, 41.0% (n=64) versus 34.9% (n=22) achieved this end point with the respective treatments (OR, 0.77 [95% CI, 0.42\u20131.41]). Although numerical differences were observed, no heterogeneity in treatment effect of dabigatran on the composite primary end point was detected in patients with and without CHD (interaction\n                      <jats:italic>P<\/jats:italic>\n                      =0.2674). In NCT02197416, recurrent VTE at 12 months occurred in 0\/17 patients with CHD versus 3\/194 (1.5%) without. No patient with CHD experienced major or clinically relevant nonmajor bleeding events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">Data on favorable anticoagulant alternatives for the unmet needs of children with CHD are emerging, and our exploratory results suggest that dabigatran could be an appropriate treatment choice, although challenging sample size limitations in pediatric studies require cautious interpretation of findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifiers: NCT01895777, NCT02197416.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.122.028957","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T05:39:51Z","timestamp":1707802791000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Dabigatran for Treatment and Secondary Prevention of Venous Thromboembolism in Pediatric Congenital Heart Disease"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7977-8848","authenticated-orcid":false,"given":"Manuela","family":"Albisetti","sequence":"first","affiliation":[{"name":"Hematology Department University Children\u2019s Hospital Z\u00fcrich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Tartakovsky","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH Ingelheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4426-8258","authenticated-orcid":false,"given":"Jacqueline","family":"Halton","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital of Eastern Ontario University of Ottawa Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Bomgaars","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Texas Children\u2019s Hospital, Baylor College of Medicine Houston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5478-0805","authenticated-orcid":false,"given":"Elizabeth","family":"Chalmers","sequence":"additional","affiliation":[{"name":"Royal Hospital for Children Glasgow Scotland UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley G.","family":"Mitchell","sequence":"additional","affiliation":[{"name":"University of Alberta Edmonton Alberta Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6939-3047","authenticated-orcid":false,"given":"Matteo","family":"Luciani","sequence":"additional","affiliation":[{"name":"Pediatric Hematology\/Oncology Department Pediatric Hospital Bambino Ges\u00f9 Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1023-1158","authenticated-orcid":false,"given":"Ildar","family":"Nurmeev","sequence":"additional","affiliation":[{"name":"Pediatric Hospital, Republic of Tatarstan Kazan Medical University Kazan Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirill","family":"Gorbatikov","sequence":"additional","affiliation":[{"name":"Pediatric Cardiovascular Surgery Regional Hospital #1 Tyumen Region Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corinna","family":"Miede","sequence":"additional","affiliation":[{"name":"mainanalytics GmbH Sulzbach (Taunus) Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1215-0746","authenticated-orcid":false,"given":"Martina","family":"Brueckmann","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH Ingelheim Germany"},{"name":"First Department of Medicine Faculty of Medicine Mannheim of the University of Heidelberg Mannheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7711-4530","authenticated-orcid":false,"given":"Leonardo R.","family":"Brand\u00e3o","sequence":"additional","affiliation":[{"name":"The Hospital for Sick Children University of Toronto Toronto Ontario Canada"},{"name":"Dalla Lana School of 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R Burns K Glatz A Male C Donti A Brand\u00e3o L Balling G VanderPluym C Bu'Lock F Kochilas L et\u00a0al. The SAXOPHONE study; a multi\u2010center multi\u2010national randomized trial of apixaban versus standard of care anticoagulation for thromboprophylaxis in children with congenital or acquired heart disease [Abstract presented at: International Society on Thrombosis and Haemostasis; July 9\u201013 2022; London UK. Abstract OC 15.2]. Accessed March 15 2023. https:\/\/abstracts.isth.org\/abstract\/the\u2010saxophone\u2010study\u2010a\u2010multi\u2010center\u2010multi\u2010national\u2010randomized\u2010trial\u2010of\u2010apixaban\u2010versus\u2010standard\u2010of\u2010care\u2010anticoagulation\u2010for\u2010thromboprophylaxis\u2010in\u2010children\u2010with\u2010congenital\u2010or\u2010acquired\u2010heart\u2010disease\/"},{"key":"e_1_3_2_40_2","doi-asserted-by":"publisher","DOI":"10.1016\/s2352-3026(19)30219-4"},{"key":"e_1_3_2_41_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtha.2022.10.020"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.122.028957","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T09:16:58Z","timestamp":1730798218000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.122.028957"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,20]]},"references-count":40,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,2,20]]}},"alternative-id":["10.1161\/JAHA.122.028957"],"URL":"https:\/\/doi.org\/10.1161\/jaha.122.028957","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,20]]},"assertion":[{"value":"2022-12-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e028957"}}