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
Bibliographic record
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 IDENTIFIER (IRRID): PRR1-10.2196/73389.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.058 | 0.085 |
| Meta-epidemiology (narrow) | 0.007 | 0.005 |
| Meta-epidemiology (broad) | 0.024 | 0.040 |
| Bibliometrics | 0.010 | 0.009 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.007 | 0.006 |
| Open science | 0.006 | 0.005 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.044 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".