Sean-Patrick Prince, Denisse Camille Dayto, Andrew Sephien, Marc Lozano, Robyn Tobillo, Natalie P Hurlock, Anil Ram, John Abernathy
{"title":"与华法林相比，直接口服抗凝药对肝硬化和脾静脉血栓患者的疗效和安全性。","authors":"Sean-Patrick Prince, Denisse Camille Dayto, Andrew Sephien, Marc Lozano, Robyn Tobillo, Natalie P Hurlock, Anil Ram, John Abernathy","doi":"10.14423/SMJ.0000000000001750","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The incidence of splanchnic vein thrombosis (SVT) is reported to be <25 times lower than that of deep vein thrombosis and pulmonary emboli, which occur in 70 to 270/100,000 cases in the general population. Current guidelines recommend initial treatment with therapeutic low-molecular-weight heparin followed by a transition to a vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) in patients with cirrhosis who develop SVT without severe liver dysfunction. This, however, is based on observational data. This study aimed to evaluate the efficacy and safety of anticoagulant therapy in patients with cirrhosis who present with SVT and receive either a DOAC or a VKA.</p><p><strong>Methods: </strong>This multicenter retrospective cohort study was conducted from December 2021 to November 2022. Patients between the ages of 18 and 75 years with cirrhosis and acute SVT who received either a VKA or a DOAC between July 2019 and July 2021 were eligible for inclusion. The primary outcome was the efficacy of treatment, defined as a new thrombotic event. The secondary outcome was the safety of treatment, defined as the development of major bleeding. Readmission data were followed up at 6 and 10 months. Bivariate analysis was conducted to assess the relationship between the medication groups and each outcome and summarized as odds ratios (ORs) with 95% confidence intervals (CIs). Statistical significance was set at 5% for all of the comparisons.</p><p><strong>Results: </strong>A total of 80 patients from 50 hospitals were included in this study. Sixty-one patients (59.02% male) received DOACs and 19 (57.89% male) received a VKA. Of the patients who received DOACs, 41 (67.21%) received apixaban, one (1.64%) received dabigatran, and 19 (31.15%) received rivaroxaban. The results from the bivariate analysis revealed no significant differences between DOACs and warfarin for both the efficacy (OR 1.46, 95% CI 0.44-4.84, <i>P</i> = 0.53) and safety outcomes (OR 1.03, 95% CI 0.04-26.43, <i>P</i> = 1) at 10 months.</p><p><strong>Conclusions: </strong>The use of DOACs in patients with cirrhosis who present with SVT may be efficacious and safe compared with warfarin. The findings from our study may inform power analyses for well-conducted randomized trials to confirm these findings.</p>","PeriodicalId":22043,"journal":{"name":"Southern Medical Journal","volume":"117 11","pages":"662-665"},"PeriodicalIF":1.0000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Direct Oral Anticoagulants Compared to Warfarin in Patients with Cirrhosis and Splanchnic Vein Thrombosis.\",\"authors\":\"Sean-Patrick Prince, Denisse Camille Dayto, Andrew Sephien, Marc Lozano, Robyn Tobillo, Natalie P Hurlock, Anil Ram, John Abernathy\",\"doi\":\"10.14423/SMJ.0000000000001750\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The incidence of splanchnic vein thrombosis (SVT) is reported to be <25 times lower than that of deep vein thrombosis and pulmonary emboli, which occur in 70 to 270/100,000 cases in the general population. Current guidelines recommend initial treatment with therapeutic low-molecular-weight heparin followed by a transition to a vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) in patients with cirrhosis who develop SVT without severe liver dysfunction. This, however, is based on observational data. This study aimed to evaluate the efficacy and safety of anticoagulant therapy in patients with cirrhosis who present with SVT and receive either a DOAC or a VKA.</p><p><strong>Methods: </strong>This multicenter retrospective cohort study was conducted from December 2021 to November 2022. Patients between the ages of 18 and 75 years with cirrhosis and acute SVT who received either a VKA or a DOAC between July 2019 and July 2021 were eligible for inclusion. The primary outcome was the efficacy of treatment, defined as a new thrombotic event. The secondary outcome was the safety of treatment, defined as the development of major bleeding. Readmission data were followed up at 6 and 10 months. Bivariate analysis was conducted to assess the relationship between the medication groups and each outcome and summarized as odds ratios (ORs) with 95% confidence intervals (CIs). Statistical significance was set at 5% for all of the comparisons.</p><p><strong>Results: </strong>A total of 80 patients from 50 hospitals were included in this study. Sixty-one patients (59.02% male) received DOACs and 19 (57.89% male) received a VKA. Of the patients who received DOACs, 41 (67.21%) received apixaban, one (1.64%) received dabigatran, and 19 (31.15%) received rivaroxaban. The results from the bivariate analysis revealed no significant differences between DOACs and warfarin for both the efficacy (OR 1.46, 95% CI 0.44-4.84, <i>P</i> = 0.53) and safety outcomes (OR 1.03, 95% CI 0.04-26.43, <i>P</i> = 1) at 10 months.</p><p><strong>Conclusions: </strong>The use of DOACs in patients with cirrhosis who present with SVT may be efficacious and safe compared with warfarin. The findings from our study may inform power analyses for well-conducted randomized trials to confirm these findings.</p>\",\"PeriodicalId\":22043,\"journal\":{\"name\":\"Southern Medical Journal\",\"volume\":\"117 11\",\"pages\":\"662-665\"},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Southern Medical Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.14423/SMJ.0000000000001750\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Southern Medical Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.14423/SMJ.0000000000001750","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Efficacy and Safety of Direct Oral Anticoagulants Compared to Warfarin in Patients with Cirrhosis and Splanchnic Vein Thrombosis.
Objective: The incidence of splanchnic vein thrombosis (SVT) is reported to be <25 times lower than that of deep vein thrombosis and pulmonary emboli, which occur in 70 to 270/100,000 cases in the general population. Current guidelines recommend initial treatment with therapeutic low-molecular-weight heparin followed by a transition to a vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) in patients with cirrhosis who develop SVT without severe liver dysfunction. This, however, is based on observational data. This study aimed to evaluate the efficacy and safety of anticoagulant therapy in patients with cirrhosis who present with SVT and receive either a DOAC or a VKA.
Methods: This multicenter retrospective cohort study was conducted from December 2021 to November 2022. Patients between the ages of 18 and 75 years with cirrhosis and acute SVT who received either a VKA or a DOAC between July 2019 and July 2021 were eligible for inclusion. The primary outcome was the efficacy of treatment, defined as a new thrombotic event. The secondary outcome was the safety of treatment, defined as the development of major bleeding. Readmission data were followed up at 6 and 10 months. Bivariate analysis was conducted to assess the relationship between the medication groups and each outcome and summarized as odds ratios (ORs) with 95% confidence intervals (CIs). Statistical significance was set at 5% for all of the comparisons.
Results: A total of 80 patients from 50 hospitals were included in this study. Sixty-one patients (59.02% male) received DOACs and 19 (57.89% male) received a VKA. Of the patients who received DOACs, 41 (67.21%) received apixaban, one (1.64%) received dabigatran, and 19 (31.15%) received rivaroxaban. The results from the bivariate analysis revealed no significant differences between DOACs and warfarin for both the efficacy (OR 1.46, 95% CI 0.44-4.84, P = 0.53) and safety outcomes (OR 1.03, 95% CI 0.04-26.43, P = 1) at 10 months.
Conclusions: The use of DOACs in patients with cirrhosis who present with SVT may be efficacious and safe compared with warfarin. The findings from our study may inform power analyses for well-conducted randomized trials to confirm these findings.
期刊介绍：
As the official journal of the Birmingham, Alabama-based Southern Medical Association (SMA), the Southern Medical Journal (SMJ) has for more than 100 years provided the latest clinical information in areas that affect patients'' daily lives. Now delivered to individuals exclusively online, the SMJ has a multidisciplinary focus that covers a broad range of topics relevant to physicians and other healthcare specialists in all relevant aspects of the profession, including medicine and medical specialties, surgery and surgery specialties; child and maternal health; mental health; emergency and disaster medicine; public health and environmental medicine; bioethics and medical education; and quality health care, patient safety, and best practices. Each month, articles span the spectrum of medical topics, providing timely, up-to-the-minute information for both primary care physicians and specialists. Contributors include leaders in the healthcare field from across the country and around the world. The SMJ enables physicians to provide the best possible care to patients in this age of rapidly changing modern medicine.
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