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Elevated International Normalized Ratio and Mortality in Hospitalized Patients Treated with Direct Oral
Orly Efros1, Aya Berman2, Gili Kenet3
1National Hemophilia Center and Thrombosis & Hemostasis Institute, Sheba Medical Center, Ramat Gan, Israel; School of Medicine, Faculty of Medicine, Tel Aviv University, Israel.
Insights
Elevated international normalized ratio (INR) in patients on direct oral anticoagulants (DOACs) indicates higher in-hospital and one-year mortality risks. These INR levels are significant prognostic markers, not just lab variations.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Medicine
Background:
- Direct oral anticoagulants (DOACs) can prolong prothrombin time and elevate the international normalized ratio (INR).
- The clinical implications of these INR changes in patients on DOACs remain unclear.
- Understanding the prognostic value of admission INR is crucial for managing these patients.
Purpose of the Study:
- To investigate the association between elevated admission INR and outcomes in hospitalized patients treated with DOACs.
- To determine if admission INR predicts in-hospital mortality and long-term survival.
Main Methods:
- Retrospective analysis of 11,399 hospitalized patients treated with DOACs.
- Data collected from Sheba Medical Center between November 2008 and July 2023.
- INR levels measured within 48 hours of hospitalization were analyzed for association with mortality.
Main Results:
- Patients with elevated INR had a 180% higher risk of in-hospital death (aOR 2.80).
- A 57% increased risk of one-year mortality was observed (aHR 1.57).
- Results were consistent across different DOACs in subgroup analyses.
Conclusions:
- Elevated admission INR in DOAC-treated patients is a significant predictor of mortality.
- These findings suggest elevated INR should be considered a prognostic marker, not merely a laboratory artifact.
- This highlights the importance of monitoring INR in hospitalized patients on DOACs.
Background:
Direct oral anticoagulants (DOACs) are associated with a prolongation of the prothrombin time and an increased international normalized ratio (INR). The clinical significance of these changes is unclear. This study aimed to examine the association between an elevated INR on admission and in-hospital death and long-term survival in patients treated with DOACs.
Methods:
Data were retrospectively retrieved from records of hospitalized patients at the Sheba Medical Center between November 2008 and July 2023. Patients were selected based on DOAC treatment, coagulation profile, and INR test done within 48 hours of hospitalization. The outcomes were in-hospital mortality and mortality in the year following hospitalization.
Results:
The study included 11,399 hospitalized patients treated with DOACs. Patients with elevated INR had a 180% higher risk of in-hospital mortality (adjusted odds ratio 2.80; 95% confidence interval, 2.30-3.39) and a 57% increased risk of death during the following year (adjusted hazard ratio 1.57; 95% confidence interval, 1.44-1.71). Similar results were observed in subgroup analyses for each DOAC.
Conclusions:
An elevated INR on admission is associated with a higher risk for in-hospital death and increased risk for mortality during the first year following hospitalization in hospitalized patients treated with DOACs. This highlights that elevated INR levels in patients on DOACs should not be dismissed as laboratory variations due to DOAC treatment, as they may serve as a prognostic marker.
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