Dataset Information

Prothrombin Time-International Normalized Ratio Predicts the Outcome of Atrial Fibrillation Patients Taking Rivaroxaban.

ABSTRACT: Although direct oral anticoagulants (DOACs) for patients with atrial fibrillation (AF) are considered to be safe, over or under anticoagulation and increased bleeding or thromboembolic risk are still considered individually. We aimed to investigate whether there is an association between prothrombin time and international normalized ratio (PT-INR) or activated partial thromboplastin time (aPTT) ratio, and the risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding among AF patients taking rivaroxaban or dabigatran. This multi-center cohort study in Taiwan included 3192 AF patients taking rivaroxaban and 958 patients taking dabigatran for stroke prevention where data about PT-INR and aPTT were available. For patients treated with rivaroxaban, a higher INR level was not associated with a higher risk of major bleeding compared to an INR level < 1.1. The risk of IS/SE was lower for patients having an INR ≥ 1.5 compared to those with an INR < 1.1 (aHR:0.57; [95%CI: 0.37-0.87]; p = 0.01). On-label dosing of rivaroxaban and use of digoxin were independent factors associated with an INR ≥ 1.5 after taking rivaroxaban. For patients taking dabigatran, a higher aPTT ratio was not associated with a higher risk of major bleeding. The risk of IS/SE was lower for patients having an aPTT ratio of 1.1-1.2 and 1.3-1.4 than those with an aPTT ratio < 1.1. In AF patients, rivaroxaban with an INR ≥ 1.5 was associated with a lower risk of IS/SE. PT-INR or aPTT ratios were not associated with bleeding events for rivaroxaban or dabigatran. INR may help predict the outcome of AF patients who take rivaroxaban.

SUBMITTER: Chao TF

PROVIDER: S-EPMC9775588 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Prothrombin Time-International Normalized Ratio Predicts the Outcome of Atrial Fibrillation Patients Taking Rivaroxaban.

Chao Tze-Fan TF Chan Yi-Hsin YH Tsai Pei-Chien PC Lee Hsin-Fu HF Chang Shang-Hung SH Kuo Chi-Tai CT Lip Gregory Y H GYH Chen Shih-Ann SA Yeh Yung-Hsin YH

Biomedicines 20221210 12

Background: Although direct oral anticoagulants (DOACs) for patients with atrial fibrillation (AF) are considered to be safe, over or under anticoagulation and increased bleeding or thromboembolic risk are still considered individually. We aimed to investigate whether there is an association between prothrombin time and international normalized ratio (PT-INR) or activated partial thromboplastin time (aPTT) ratio, and the risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding among ...[more]

PMID: 36551966

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Project description:ObjectiveThe study investigates the diagnostic and prognostic significance of the prothrombin time/international normalized ratio (PT/INR) in patients with sepsis and septic shock.BackgroundSepsis may be complicated by disseminated intravascular coagulation (DIC). While the status of coagulopathy of septic patients is represented within the sepsis-3 definition by assessing the platelet count, less data regarding the prognostic impact of the PT/INR in patients admitted with sepsis and septic shock is available.MethodsConsecutive patients with sepsis and septic shock from 2019 to 2021 were included. Blood samples were retrieved from day of disease onset (ie, day 0), as well as on day 1, 2, 4, 6 and 9 thereafter. Firstly, the diagnostic value of the PT/INR in comparison to the activated partial thromboplastin time (aPTT) was tested for septic shock compared to sepsis without shock. Secondly, the prognostic value of the PT/INR for 30-day all-cause mortality was tested. Statistical analyses included univariable t-tests, Spearman's correlations, C-statistics, Kaplan-Meier analyses and Cox proportional regression analyses.Results338 patients were included (56% sepsis without shock, 44% septic shock). The overall rate of all-cause mortality at 30 days was 52%. With an area under the curve (AUC) of 0.682 (p= .001) on day 0, the PT/INR revealed moderate discrimination of septic shock and sepsis without shock. Furthermore, PT/ INR was able to discriminate non-survivors and survivors at 30 days (AUC = 0.612; p = .001). Patients with a PT/INR >1.5 had higher rates of 30-day all-cause mortality than patients with lower values (mortality rate 73% vs 48%; log rank p = .001; HR = 2.129; 95% CI 1.494-3.033; p = .001), even after multivariable adjustment (HR = 1.793; 95% CI 1.343-2.392; p = .001). Increased risk of 30-day all-cause mortality was observed irrespective of concomitant thrombocytopenia.ConclusionThe PT/INR revealed moderate diagnostic accuracy for septic shock but was associated with reliable prognostic accuracy with regard to 30-day all-cause mortality in patients admitted with sepsis and septic shock.

Project description:BackgroundReal-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment.Methods and resultsBetween January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines).ConclusionsThe RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world.Trial registrationUnique identifier: NCT02444221. Registerd 14 May 2015; Retrospectively Registered.

Dataset Information

Prothrombin Time-International Normalized Ratio Predicts the Outcome of Atrial Fibrillation Patients Taking Rivaroxaban.

Publications

Prothrombin Time-International Normalized Ratio Predicts the Outcome of Atrial Fibrillation Patients Taking Rivaroxaban.

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