دورية أكاديمية
أعرض في EDS

Safety of 4-factor prothrombin complex concentrate (4F-PCC) for emergent reversal of factor Xa inhibitors.

التفاصيل البيبلوغرافية
العنوان: Safety of 4-factor prothrombin complex concentrate (4F-PCC) for emergent reversal of factor Xa inhibitors.
المؤلفون: Tao J; Department of Anesthesiology, Yale School of Medicine, 333 Cedar Street, TMP 3, PO Box 20805, New Haven, CT 06520-8051 USA., Bukanova EN; Department of Anesthesiology, Yale School of Medicine, 333 Cedar Street, TMP 3, PO Box 20805, New Haven, CT 06520-8051 USA., Akhtar S; Department of Anesthesiology, Yale School of Medicine, 333 Cedar Street, TMP 3, PO Box 20805, New Haven, CT 06520-8051 USA.
المصدر: Journal of intensive care [J Intensive Care] 2018 Jun 14; Vol. 6, pp. 34. Date of Electronic Publication: 2018 Jun 14 (Print Publication: 2018).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101627304 Publication Model: eCollection Cited Medium: Print ISSN: 2052-0492 (Print) Linking ISSN: 20520492 NLM ISO Abbreviation: J Intensive Care Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, 2013-
مستخلص: Background: Although factor Xa inhibitors have become a popular choice for chronic oral anticoagulation, effective drug reversal remains difficult due to a lack of specific antidote. Currently, 4-factor prothrombin complex concentrate (4F-PCC) is considered the treatment of choice for factor Xa inhibitor-related major bleeding. However, safety of 4F-PCC and its risk of thrombosis when used for this off-label purpose remain unclear. The purpose of this retrospective study is to determine the rate of thromboembolism when 4F-PCC is used for the emergent reversal of factor Xa inhibitors.
Methods: We conducted a single-center retrospective review of medical records between 2013 and 2017. Patients were included if they received 4F-PCC to reverse rivaroxaban, apixaban, or edoxaban for emergent invasive procedures or during episodes of major bleeding defined as bleeding with hemodynamic instability, fall in hemoglobin of 2 g/dL, or bleeding requiring blood transfusion. Thrombotic events including myocardial infarction, pulmonary embolism, deep vein thrombosis, cerebral vascular accident, and arterial thrombosis of the limb or mesentery were recorded if they occurred within 14 days of 4F-PCC administration. Data was analyzed using point and interval estimation to approximate the rate and confidence interval of thromboembolic events.
Results: Forty-three patients were identified in our review. Doses of 4F-PCC were determined by the treating physician and mainly ranged from 25 to 50 IU/kg. Twenty-two patients (51.2%) received both sequential compression devices (SCDs) and subcutaneous heparin for DVT prophylaxis. Twenty-one patients (48.8%) were placed on SCDs only. Three patients received concomitant FFP. Thrombotic events within 14 days of 4F-PCC administration occurred in 1 out of 43 patients (2.1%, 95% CI [0.1-12.3]). This thrombotic event was an upper extremity DVT which occurred 1 day after the patient received 1325 IU (25 IU/kg) of 4F-PCC to reverse rivaroxaban for traumatic intracranial hemorrhage. The patient was taken for emergent decompressive craniotomy after rivaroxaban reversal. In patients who did not undergo surgery or who underwent minor invasive procedures, no thrombotic events were noted.
Conclusion: Based on our preliminary data, the thromboembolic rate of 4F-PCC when given at a dose of 25-50 IU/kg to emergently reverse rivaroxaban and apixaban appears acceptable. Since many patients who require 4F-PCC to emergently reverse factor Xa inhibitors will be at high risk of developing thrombotic events, practitioners should be highly vigilant of these complications. Large, multicenter prospective trials are needed to further determine this risk.
Competing Interests: The authors confirm that any aspect of the work covered in this manuscript has been conducted with the ethical approval from Yale New Haven Hospital’s Institutional Review Board. Consent to participate was waived by the Institutional Review Board as data collection was retrospective with minimal risks to subjects.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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فهرسة مساهمة: Keywords: 4-factor prothrombin complex concentrates; Anticoagulation reversal; Drug safety; Factor Xa inhibitor; Novel oral anticoagulant; Thromboembolism
تواريخ الأحداث: Date Created: 20180627 Latest Revision: 20220318
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC6001072
DOI: 10.1186/s40560-018-0303-y
PMID: 29942519
قاعدة البيانات: MEDLINE
الوصف
تدمد:2052-0492
DOI:10.1186/s40560-018-0303-y