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The Reconstructed Individual Patient Data from Kaplan-Meier (IPDfromKM) Method for Non-Inferiority Analyses: A New
Eugenia Piragine1,2, Sabrina Trippoli3, Sara Veneziano1
1Department of Pharmacy, University of Pisa, Via Bonanno 6, 56126 Pisa, Italy.
Methods and Protocols
|February 25, 2025
Summary
The IPDfromKM method, an AI tool, can now validate non-inferiority analyses. This artificial intelligence approach demonstrated the non-inferiority of left atrial appendage devices compared to anticoagulants for atrial fibrillation management.
Area of Science:
- Medical Informatics
- Biostatistics
- Cardiology
Background:
- The IPDfromKM method reconstructs individual patient data from Kaplan-Meier curves for indirect study comparisons.
- While typically used for superiority analyses, its application in non-inferiority analyses lacks validation.
- Left atrial appendage occlusion devices are established as non-inferior to oral anticoagulants for atrial fibrillation.
Purpose of the Study:
- To validate the IPDfromKM method for non-inferiority analyses.
- To leverage existing data on left atrial appendage devices versus oral anticoagulants in atrial fibrillation.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) from PubMed.
- Utilized R software for survival analysis comparing Watchman and Amlet devices against warfarin.
- Hazard ratio (HR) with 95% confidence intervals (CI) were the primary outcome measures.
Main Results:
- The analysis confirmed the non-inferiority of both Watchman (HR: 1.23, 95% CI: 0.80-1.9) and Amlet (HR: 1.05, 95% CI: 0.61-1.80) devices compared to warfarin.
- The IPDfromKM method successfully supported the non-inferiority hypothesis.
Conclusions:
- The IPDfromKM method is validated for non-inferiority analyses.
- This artificial intelligence method offers a valuable tool for decision-making in managing atrial fibrillation and other conditions.
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