A Higher-Than-Standard-Intensity International Normalized Ratio Goal for Patients Undergoing Mechanical Aortic Valve Replacement With Additional Thrombotic Risk Factors: Protocol for a Systematic Review and Meta-Analysis (Preprint)

Myung-Rho Kim; Taha Shaikh; Shawn Wang; S. H. Taylor; Vidhani Goel; Banveet Kaur Khetarpal; Chowdhury Ahsan; Kavita Batra

doi:10.2196/preprints.73389

March 21, 2025Open Access

A Higher-Than-Standard-Intensity International Normalized Ratio Goal for Patients Undergoing Mechanical Aortic Valve Replacement With Additional Thrombotic Risk Factors: Protocol for a Systematic Review and Meta-Analysis (Preprint)

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Why the study?

Limited clinical evidence exists to guide anticoagulation intensity in patients with MAVR and additional thromboembolic risk factors.

Does a higher than standard-intensity INR goal benefit patients with MAVR and additional thrombotic risk factors?

Structured PICO

Does a higher than standard-intensity INR goal benefit patients with MAVR and additional thrombotic risk factors?

P

Population

Adult patients (>18 years) with mechanical aortic valve replacement (MAVR) on warfarin therapy, with additional thromboembolic risk factors (e.g., atrial fibrillation, previous venous thromboembolism, hypercoagulability, or severe left ventricular dysfunction). Excludes patients with bioprosthetic AVR, non-bileaflet mechanical valves, and those not on warfarin.

I

Intervention

Higher-intensity INR goals (>3.0) with warfarin therapy

C

Comparator

Standard-intensity INR goals (approximately 2.5) with warfarin therapy

O

Outcome

Major or minor bleeding event; Major or minor thrombotic eventhard clinical

Limitations

Heterogeneity due to different settings, demographics, endpoints, and INR goals
Potential for reviewer bias
Risk of publication bias
Variable study methodologies leading to diverse outcomes

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Implication

This protocol outlines a systematic review and meta-analysis to evaluate whether higher-intensity anticoagulation (INR >3.0) is safer and more effective than standard-intensity (INR 2.5) in patients with mechanical aortic valve replacement and additional thromboembolic risk factors.

Abstract

BACKGROUND Lifelong anticoagulation therapy with vitamin K antagonists is recommended following mechanical aortic valve replacement (MAVR) to prevent valve thrombosis. Current guidelines recommend a standard international normalized ratio (INR) of 2.5 for patients with MAVR without additional thromboembolic risk factors, and a higher INR goal of 3.0 for those with conditions such as atrial fibrillation, prior thromboembolism, or left ventricular dysfunction. However, limited clinical evidence exists to guide anticoagulation intensity in this high-risk subgroup, necessitating a systematic review. OBJECTIVE We aimed to assess the safety and efficacy of higher-intensity INR goals (>3.0) compared to standard-intensity goals (approximately 2.5) in patients with MAVR with additional thromboembolic risk factors. METHODS This protocol describes a systematic review and meta-analysis following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. A comprehensive literature search will be conducted across PubMed, Embase, and the Cochrane Library for studies published before December 18, 2024. Eligible studies include randomized controlled trials (RCTs), cohort studies, and follow-up studies involving adult patients with MAVR on warfarin therapy, stratified by the presence of additional thromboembolic risk factors. Non–English-language studies, case reports, editorials, and animal studies will be excluded. RESULTS The review will synthesize existing data to compare the risks and benefits of intensified anticoagulation in patients with MAVR with additional thromboembolic risk factors. Data analysis and manuscript preparation are scheduled for July-August 2025. CONCLUSIONS This study will provide critical evidence on INR management in high-risk patients with MAVR, potentially informing future updates to clinical guidelines and optimizing the balance between thromboembolic prevention and bleeding risk. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/73389

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Cite This Study

Kim et al. (2025) studied this question.

synapsesocial.com/papers/6a70ba5b660549caf2c55a84 https://doi.org/10.2196/preprints.73389

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A Higher-Than-Standard-Intensity International Normalized Ratio Goal for Patients Undergoing Mechanical Aortic Valve Replacement With Additional Thrombotic Risk Factors: Protocol for a Systematic Review and Meta-Analysis (Preprint)

Structured PICO

Limitations

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Implication

Abstract

Discussion

Cite This Study

A Higher-Than-Standard-Intensity International Normalized Ratio Goal for Patients Undergoing Mechanical Aortic Valve Replacement With Additional Thrombotic Risk Factors: Protocol for a Systematic Review and Meta-Analysis (Preprint)

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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