Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 21, 2025
Open Peer Review Period: Mar 24, 2025 - May 19, 2025
Date Accepted: May 29, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Does a Higher than Standard-Intensity INR Goal Benefit Patients with MAVR and Additional Thrombotic Risk Factors: A Protocol for Systematic Review and Meta-analysis
ABSTRACT
Background:
Lifelong anticoagulation with vitamin K antagonists is required to prevent prosthetic valve thrombosis after mechanical aortic valve replacement (MAVR). Current guidelines recommend a standard international normalized ratio (INR) of 2.5 for MAVR patients without additional thromboembolic risk factors, while a higher INR of 3.0 is advised for those with conditions such as atrial fibrillation, prior thromboembolism, or left ventricular dysfunction. However, limited clinical data exist to validate the optimal anticoagulation intensity for this high-risk population, necessitating further investigation.
Objective:
This systematic review and meta-analysis aim to assess the risks and potential benefits of higher-intensity anticoagulation goals (INR>3.0) in MAVR patients with additional thromboembolic risk factors.
Methods:
A comprehensive literature search will be conducted, including case studies, randomized controlled trials (RCTs), and follow-up studies published before December 18, 2024. The study population includes MAVR patients on Warfarin therapy, with and without additional thromboembolic risk factors. Studies involving bioprosthetic valves, non-bileaflet mechanical valves, and patients not on Warfarin will be excluded. Data will be extracted and analyzed following PRISMA guidelines, with statistical comparisons evaluating thromboembolic and bleeding events.
Results:
The study follows a structured timeline: protocol development was completed in December 2024, with the search strategy finalized in January 2025. Screening stages (title, abstract, and full-text) span February to May. Data extraction, synthesis, and risk of bias assessment occur in May and June, followed by data analysis and manuscript drafting from July to August. Submission and peer review are scheduled for September 2025.
Conclusions:
This systematic review will provide critical insights into anticoagulation management in MAVR patients with thromboembolic risk factors. Given the scarcity of targeted research, these findings may inform future guideline revisions, balancing thrombotic prevention with bleeding risks. Further prospective studies will be needed to validate these conclusions. Clinical Trial: CRD42025639037
Citation
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Copyright
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