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- Title
Prothrombin Complex Concentrate vs Conservative Management in ICH Associated With Direct Oral Anticoagulants.
- Authors
Ip, Bonaventure; Pan, Sangqi; Yuan, Zhong; Hung, Trista; Ko, Ho; Leng, Xinyi; Liu, Yuying; Li, Shuang; Lee, Sing Yau; Cheng, Cyrus; Chan, Howard; Mok, Vincent; Soo, Yannie; Wu, Xiaoli; Lui, Leong Ting; Chan, Rosa; Abrigo, Jill; Dou, Qi; Seiffge, David; Leung, Thomas
- Abstract
Key Points: Question: Is prothrombin complex concentrate (PCC) treatment useful for patients who develop intracerebral hemorrhage (ICH) during direct oral anticoagulant (DOAC) usage? Findings: In this cohort study of 232 patients in Hong Kong, 31% of patients with DOAC-associated ICH achieved good neurological recovery and 39% died within 90 days. PCC treatment was not associated with neurological outcomes, hematoma expansion, or survival. Meaning: In this study, PCC treatment was not associated with improved functional outcome, hematoma expansion, or mortality among patients with DOAC-associated ICH. This cohort study compares the clinical and radiological outcomes of direct oral anticoagulant (DOAC)–associated intracerebral hemorrhage (ICH) treated with prothrombin complex concentrate vs conservative management among patients in Hong Kong. Importance: Intracerebral hemorrhage (ICH) associated with direct oral anticoagulant (DOAC) use carries extremely high morbidity and mortality. The clinical effectiveness of hemostatic therapy is unclear. Objective: To compare the clinical and radiological outcomes of DOAC-associated ICH treated with prothrombin complex concentrate (PCC) vs conservative management. Design, Setting, and Participants: In this population-based, propensity score–weighted retrospective cohort study, patients who developed DOAC-associated ICH from January 1, 2016, to December 31, 2021, in Hong Kong were identified. The outcomes of patients who received 25 to 50 IU/kg PCC with those who received no hemostatic agents were compared. Data were analyzed from May 1, 2022, to June 30, 2023. Main Outcomes and Measures: The primary outcome was modified Rankin scale of 0 to 3 or returning to baseline functional status at 3 months. Secondary outcomes were mortality at 90 days, in-hospital mortality, and hematoma expansion. Weighted logistic regression was performed to evaluate the association of PCC with study outcomes. In unweighted logistic regression models, factors associated with good neurological outcome and hematoma expansion in DOAC-associated ICH were identified. Results: A total of 232 patients with DOAC-associated ICH, with a mean (SD) age of 77.2 (9.3) years and 101 (44%) female patients, were included. Among these, 116 (50%) received conservative treatment and 102 (44%) received PCC. Overall, 74 patients (31%) patients had good neurological recovery and 92 (39%) died within 90 days. Median (IQR) baseline hematoma volume was 21.7 mL (3.6-66.1 mL). Compared with conservative management, PCC was not associated with improved neurological recovery (adjusted odds ratio [aOR], 0.62; 95% CI, 0.33-1.16; P =.14), mortality at 90 days (aOR, 1.03; 95% CI, 0.70-1.53; P =.88), in-hospital mortality (aOR, 1.11; 95% CI, 0.69-1.79; P =.66), or reduced hematoma expansion (aOR, 0.94; 95% CI, 0.38-2.31; P =.90). Higher baseline hematoma volume, lower Glasgow coma scale, and intraventricular hemorrhage were associated with lower odds of good neurological outcome but not hematoma expansion. Conclusions and Relevance: In this cohort study, Chinese patients with DOAC-associated ICH had large baseline hematoma volumes and high rates of mortality and functional disability. PCC treatment was not associated with improved functional outcome, hematoma expansion, or mortality. Further studies on novel hemostatic agents as well as neurosurgical and adjunctive medical therapies are needed to identify the best management algorithm for DOAC-associated ICH.
- Subjects
HEMORRHAGE risk factors; CONSERVATIVE treatment; CEREBROVASCULAR disease; ORAL drug administration; MULTIVARIATE analysis; ANTICOAGULANTS; PROTHROMBIN; RETROSPECTIVE studies; MANN Whitney U Test; RISK assessment; CHI-squared test; DESCRIPTIVE statistics; GLASGOW Coma Scale; DATA analysis software; LOGISTIC regression analysis; LONGITUDINAL method; PROPORTIONAL hazards models; SECONDARY analysis
- Publication
JAMA Network Open, 2024, Vol 7, Issue 2, pe2354916
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.54916