Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis

Background Antiphospholipid Syndrome (APS) is an autoimmune condition that increases thrombosis risk. Although Vitamin K antagonists (VKA) are standard treatment, interest in direct oral anticoagulants (DOAC) has grown. Recent studies evaluated DOAC across all APS subgroups. This review updates our...

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Main Authors: Lama Alfehaid PharmD, MME, Nada Alsuhebany PharmD, Hussah Albahlal PharmD, Albatoul Alomran PharmD, Abdulmajeed M Alshehri PharmD, Mohammed AlSheef MD, Abdulaali Almutairi PharmD, PhD
Format: Article
Language:English
Published: SAGE Publishing 2025-08-01
Series:Clinical and Applied Thrombosis/Hemostasis
Online Access:https://doi.org/10.1177/10760296251364269
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author Lama Alfehaid PharmD, MME
Nada Alsuhebany PharmD
Hussah Albahlal PharmD
Albatoul Alomran PharmD
Abdulmajeed M Alshehri PharmD
Mohammed AlSheef MD
Abdulaali Almutairi PharmD, PhD
author_facet Lama Alfehaid PharmD, MME
Nada Alsuhebany PharmD
Hussah Albahlal PharmD
Albatoul Alomran PharmD
Abdulmajeed M Alshehri PharmD
Mohammed AlSheef MD
Abdulaali Almutairi PharmD, PhD
author_sort Lama Alfehaid PharmD, MME
collection DOAJ
description Background Antiphospholipid Syndrome (APS) is an autoimmune condition that increases thrombosis risk. Although Vitamin K antagonists (VKA) are standard treatment, interest in direct oral anticoagulants (DOAC) has grown. Recent studies evaluated DOAC across all APS subgroups. This review updates our understanding of DOAC's efficacy and safety compared to VKA in preventing thrombotic complications, integrating new findings into the literature. Methods A systematic review across PubMed/Medline, Embase, and Cochrane was conducted in accordance with PRISMA guidelines. The quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Cochrane Risk of Bias tool and the Newcastle-Ottawa Scale, respectively. Meta-analysis calculated odds ratios (OR) using the random effect model for arterial and venous thrombotic and bleeding outcomes Results Of a total of 2385 records identified, the meta-analysis included 11 studies, comprising 5 RCTs and 7 observational studies, with a combined total of 1813 participants. The analysis revealed no significant difference in the odds of venous thromboembolism (VTE) between DOAC and VKA (OR = 0.80; 95% CI 0.41-1.56). However, a significant increase in thromboembolism recurrence was noted in triple-positive APS patients using DOAC compared to VKA (OR = 3.62; 95% CI 1.10-11.98). The risk of major bleeding was similar between DOAC and VKA (OR = 1.02; 95% CI 0.62-1.68). Additionally, the pooled analysis indicated a higher risk of arterial thrombosis with DOAC (OR = 6.21; 95% CI 2.06-18.76). Conclusion Overall, findings suggest DOAC are comparably safe but increase the risk of arterial thrombosis and VTE in triple-positive APS, favoring warfarin for prophylaxis.
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spelling doaj-art-ccfd6bdea4ca4415ac52fb6bbd3739662025-08-20T03:58:15ZengSAGE PublishingClinical and Applied Thrombosis/Hemostasis1938-27232025-08-013110.1177/10760296251364269Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-AnalysisLama Alfehaid PharmD, MME0Nada Alsuhebany PharmD1Hussah Albahlal PharmD2Albatoul Alomran PharmD3Abdulmajeed M Alshehri PharmD4Mohammed AlSheef MD5Abdulaali Almutairi PharmD, PhD6 , Riyadh, Saudi Arabia , Riyadh, Saudi Arabia Department of Pharmacy Practice, College of Pharmacy, , Riyadh, Saudi Arabia Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia , Riyadh, Saudi Arabia College of Medicine, Alfaisal University, Riyadh, Saudi Arabia Drug Safety and Risk Management, , Riyadh, Saudi Arabia Background Antiphospholipid Syndrome (APS) is an autoimmune condition that increases thrombosis risk. Although Vitamin K antagonists (VKA) are standard treatment, interest in direct oral anticoagulants (DOAC) has grown. Recent studies evaluated DOAC across all APS subgroups. This review updates our understanding of DOAC's efficacy and safety compared to VKA in preventing thrombotic complications, integrating new findings into the literature. Methods A systematic review across PubMed/Medline, Embase, and Cochrane was conducted in accordance with PRISMA guidelines. The quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Cochrane Risk of Bias tool and the Newcastle-Ottawa Scale, respectively. Meta-analysis calculated odds ratios (OR) using the random effect model for arterial and venous thrombotic and bleeding outcomes Results Of a total of 2385 records identified, the meta-analysis included 11 studies, comprising 5 RCTs and 7 observational studies, with a combined total of 1813 participants. The analysis revealed no significant difference in the odds of venous thromboembolism (VTE) between DOAC and VKA (OR = 0.80; 95% CI 0.41-1.56). However, a significant increase in thromboembolism recurrence was noted in triple-positive APS patients using DOAC compared to VKA (OR = 3.62; 95% CI 1.10-11.98). The risk of major bleeding was similar between DOAC and VKA (OR = 1.02; 95% CI 0.62-1.68). Additionally, the pooled analysis indicated a higher risk of arterial thrombosis with DOAC (OR = 6.21; 95% CI 2.06-18.76). Conclusion Overall, findings suggest DOAC are comparably safe but increase the risk of arterial thrombosis and VTE in triple-positive APS, favoring warfarin for prophylaxis.https://doi.org/10.1177/10760296251364269
spellingShingle Lama Alfehaid PharmD, MME
Nada Alsuhebany PharmD
Hussah Albahlal PharmD
Albatoul Alomran PharmD
Abdulmajeed M Alshehri PharmD
Mohammed AlSheef MD
Abdulaali Almutairi PharmD, PhD
Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis
Clinical and Applied Thrombosis/Hemostasis
title Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis
title_full Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis
title_fullStr Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis
title_full_unstemmed Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis
title_short Evaluating the Efficacy and Safety of Direct Oral Anticoagulants Compared to Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: Updated Systematic Review and Meta-Analysis
title_sort evaluating the efficacy and safety of direct oral anticoagulants compared to vitamin k antagonists in patients with antiphospholipid syndrome updated systematic review and meta analysis
url https://doi.org/10.1177/10760296251364269
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