{"title":"Safety and Efficacy of DOAC Versus VKA in Adult Congenital Heart Disease: A Systematic Review and Meta-Analysis.","authors":"Aamina Shakir, Jacinthe Khater, Fatima Iqbal, Erin Ware, George Mina, Khagendra Dahal, Kalgi Modi","doi":"10.1007/s40256-025-00720-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients with adult congenital heart disease (CHD) have various indications for anticoagulation (e.g., presence of Fontan circuit, atrial fibrillation due to surgical scar). Guidelines recommend vitamin K antagonists (VKA) for thromboprophylaxis in adult CHD, as trial data comparing safety/efficacy of direct oral anticoagulants (DOAC) to VKA are not available in this population.</p><p><strong>Methods: </strong>PubMed/MEDLINE, Embase, Web of Science, and Google Scholar were searched for trials comparing DOAC with VKA in patients with ACHD. Outcomes of interest were efficacy endpoints (thromboembolic complications) and safety endpoints (bleeding complications). Results were meta-analyzed and sensitivity analyses were performed.</p><p><strong>Results: </strong>A total of 4 retrospective studies comprising 6004 patients (2566 DOAC, 3438 VKA) were analyzed. Compared with VKA, DOAC did not cause a statistically significant difference in incidence of thromboembolism (risk ratio, RR, 0.76; 95% confidence intervals, CI, 0.28, 2.07); composite bleeding (RR 1.02, 95% CI 0.71, 1.47); major bleeding (RR 1.05, 95% CI 0.92, 1.21); minor bleeding (RR 1.12, 95% CI 0.51, 2.44); or intracranial bleeding (RR 0.86, 95% CI 0.50, 1.46). Numerically, the DOAC arm had fewer thromboembolisms/intracranial bleeds but more major/composite bleeds. However, upon removal of the largest study, the DOAC arm had fewer major/composite bleeds.</p><p><strong>Conclusions: </strong>DOAC did not confer a significant increase in either thromboembolic or bleeding risk as compared with VKA. Sensitivity analysis showed notable heterogeneity among studies. Large-scale trials comparing DOAC with VKA in patients with adult CHD are needed.</p>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Cardiovascular Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40256-025-00720-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Patients with adult congenital heart disease (CHD) have various indications for anticoagulation (e.g., presence of Fontan circuit, atrial fibrillation due to surgical scar). Guidelines recommend vitamin K antagonists (VKA) for thromboprophylaxis in adult CHD, as trial data comparing safety/efficacy of direct oral anticoagulants (DOAC) to VKA are not available in this population.
Methods: PubMed/MEDLINE, Embase, Web of Science, and Google Scholar were searched for trials comparing DOAC with VKA in patients with ACHD. Outcomes of interest were efficacy endpoints (thromboembolic complications) and safety endpoints (bleeding complications). Results were meta-analyzed and sensitivity analyses were performed.
Results: A total of 4 retrospective studies comprising 6004 patients (2566 DOAC, 3438 VKA) were analyzed. Compared with VKA, DOAC did not cause a statistically significant difference in incidence of thromboembolism (risk ratio, RR, 0.76; 95% confidence intervals, CI, 0.28, 2.07); composite bleeding (RR 1.02, 95% CI 0.71, 1.47); major bleeding (RR 1.05, 95% CI 0.92, 1.21); minor bleeding (RR 1.12, 95% CI 0.51, 2.44); or intracranial bleeding (RR 0.86, 95% CI 0.50, 1.46). Numerically, the DOAC arm had fewer thromboembolisms/intracranial bleeds but more major/composite bleeds. However, upon removal of the largest study, the DOAC arm had fewer major/composite bleeds.
Conclusions: DOAC did not confer a significant increase in either thromboembolic or bleeding risk as compared with VKA. Sensitivity analysis showed notable heterogeneity among studies. Large-scale trials comparing DOAC with VKA in patients with adult CHD are needed.
期刊介绍：
Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents.
Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations.
The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
