Yaser Jenab, Parham Sadeghipour, Reza Mohseni-Badalabadi, Raheleh Kaviani, Kaveh Hosseini, Yeganeh Pasebani, Hamid Khederlou, Ali Rafati, Zohre Mohammadi, Sepehr Jamalkhani, Azita Haj Hossein Talasaz, Ata Firouzi, Hamid Ariannejad, Mohammad Javad Alemzadeh-Ansari, Sajjad Ahmadi-Renani, Mohsen Maadani, Melody Farrashi, Hooman Bakhshandeh, Gregory Piazza, Harlan M Krumholz, Roxana Mehran, Gregory Y H Lip, Behnood Bikdeli
{"title":"st段抬高型心肌梗死后左室血栓患者直接口服抗凝剂或华法林：一项试点试验和预先指定的随机试验荟萃分析","authors":"Yaser Jenab, Parham Sadeghipour, Reza Mohseni-Badalabadi, Raheleh Kaviani, Kaveh Hosseini, Yeganeh Pasebani, Hamid Khederlou, Ali Rafati, Zohre Mohammadi, Sepehr Jamalkhani, Azita Haj Hossein Talasaz, Ata Firouzi, Hamid Ariannejad, Mohammad Javad Alemzadeh-Ansari, Sajjad Ahmadi-Renani, Mohsen Maadani, Melody Farrashi, Hooman Bakhshandeh, Gregory Piazza, Harlan M Krumholz, Roxana Mehran, Gregory Y H Lip, Behnood Bikdeli","doi":"10.4244/EIJ-D-24-00527","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.</p><p><strong>Aims: </strong>We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.</p><p><strong>Methods: </strong>Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.0-2.5) in an open-label, randomised clinical trial (RCT). A prospective pooled analysis was planned comparing DOAC- versus warfarin-based anticoagulation for the same indication. The main outcome of the RCT was complete LVT resolution at 3 months, determined by a blinded imaging core laboratory. Complete LVT resolution and bleeding were investigated in the pooled analysis.</p><p><strong>Results: </strong>A total of 50 patients (median age: 55 years, 18% females) were enrolled from June 2020 to November 2022. Three-month complete LVT resolution occurred in 19/25 (76.0%) patients assigned to rivaroxaban and 13/24 (54.2%) assigned to warfarin (relative risk [RR] 1.40, 95% confidence interval [CI]: 0.91-2.15; p=0.12) with no thrombotic or major bleeding events. Pooled analysis showed numerically better complete LVT resolution with DOACs (rivaroxaban and apixaban; 93/115 [80.8%] vs 79/112 [70.5%], RR 1.14, 95% CI: 0.98-1.32; p=0.08) and less major bleeding (2/116 [1.7%] and 9/112 [8.0%], risk difference -0.06, 95% CI: -0.12 to 0.00; p=0.05) than with warfarin.</p><p><strong>Conclusions: </strong>Although the findings are limited by a small sample size, the results suggest that DOACs are safe with at least similar outcomes concerning LVT resolution and major bleeding compared with warfarin. (ClinicalTrials.gov: NCT05705089).</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 1","pages":"82-92"},"PeriodicalIF":7.6000,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684328/pdf/","citationCount":"0","resultStr":"{\"title\":\"Direct oral anticoagulants or warfarin in patients with left ventricular thrombus after ST-elevation myocardial infarction: a pilot trial and a prespecified meta-analysis of randomised trials.\",\"authors\":\"Yaser Jenab, Parham Sadeghipour, Reza Mohseni-Badalabadi, Raheleh Kaviani, Kaveh Hosseini, Yeganeh Pasebani, Hamid Khederlou, Ali Rafati, Zohre Mohammadi, Sepehr Jamalkhani, Azita Haj Hossein Talasaz, Ata Firouzi, Hamid Ariannejad, Mohammad Javad Alemzadeh-Ansari, Sajjad Ahmadi-Renani, Mohsen Maadani, Melody Farrashi, Hooman Bakhshandeh, Gregory Piazza, Harlan M Krumholz, Roxana Mehran, Gregory Y H Lip, Behnood Bikdeli\",\"doi\":\"10.4244/EIJ-D-24-00527\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.</p><p><strong>Aims: </strong>We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.</p><p><strong>Methods: </strong>Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.0-2.5) in an open-label, randomised clinical trial (RCT). A prospective pooled analysis was planned comparing DOAC- versus warfarin-based anticoagulation for the same indication. The main outcome of the RCT was complete LVT resolution at 3 months, determined by a blinded imaging core laboratory. Complete LVT resolution and bleeding were investigated in the pooled analysis.</p><p><strong>Results: </strong>A total of 50 patients (median age: 55 years, 18% females) were enrolled from June 2020 to November 2022. Three-month complete LVT resolution occurred in 19/25 (76.0%) patients assigned to rivaroxaban and 13/24 (54.2%) assigned to warfarin (relative risk [RR] 1.40, 95% confidence interval [CI]: 0.91-2.15; p=0.12) with no thrombotic or major bleeding events. Pooled analysis showed numerically better complete LVT resolution with DOACs (rivaroxaban and apixaban; 93/115 [80.8%] vs 79/112 [70.5%], RR 1.14, 95% CI: 0.98-1.32; p=0.08) and less major bleeding (2/116 [1.7%] and 9/112 [8.0%], risk difference -0.06, 95% CI: -0.12 to 0.00; p=0.05) than with warfarin.</p><p><strong>Conclusions: </strong>Although the findings are limited by a small sample size, the results suggest that DOACs are safe with at least similar outcomes concerning LVT resolution and major bleeding compared with warfarin. (ClinicalTrials.gov: NCT05705089).</p>\",\"PeriodicalId\":54378,\"journal\":{\"name\":\"Eurointervention\",\"volume\":\"21 1\",\"pages\":\"82-92\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2025-01-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684328/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eurointervention\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4244/EIJ-D-24-00527\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-00527","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Direct oral anticoagulants or warfarin in patients with left ventricular thrombus after ST-elevation myocardial infarction: a pilot trial and a prespecified meta-analysis of randomised trials.
Background: The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.
Aims: We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.
Methods: Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.0-2.5) in an open-label, randomised clinical trial (RCT). A prospective pooled analysis was planned comparing DOAC- versus warfarin-based anticoagulation for the same indication. The main outcome of the RCT was complete LVT resolution at 3 months, determined by a blinded imaging core laboratory. Complete LVT resolution and bleeding were investigated in the pooled analysis.
Results: A total of 50 patients (median age: 55 years, 18% females) were enrolled from June 2020 to November 2022. Three-month complete LVT resolution occurred in 19/25 (76.0%) patients assigned to rivaroxaban and 13/24 (54.2%) assigned to warfarin (relative risk [RR] 1.40, 95% confidence interval [CI]: 0.91-2.15; p=0.12) with no thrombotic or major bleeding events. Pooled analysis showed numerically better complete LVT resolution with DOACs (rivaroxaban and apixaban; 93/115 [80.8%] vs 79/112 [70.5%], RR 1.14, 95% CI: 0.98-1.32; p=0.08) and less major bleeding (2/116 [1.7%] and 9/112 [8.0%], risk difference -0.06, 95% CI: -0.12 to 0.00; p=0.05) than with warfarin.
Conclusions: Although the findings are limited by a small sample size, the results suggest that DOACs are safe with at least similar outcomes concerning LVT resolution and major bleeding compared with warfarin. (ClinicalTrials.gov: NCT05705089).
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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