Activated Prothrombin Complex Concentrate versus Plasma for Reversal of Warfarin-Associated Hemorrhage

Anthony Rowe, Pinky S. Mahbubani, Mason H. Bucklin, Christopher Clark, Leslie Hamilton

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Study Objective: To evaluate the efficacy and safety of an activated four-factor prothrombin complex concentrate (aPCC) versus plasma for the reversal of warfarin-associated hemorrhage. Design: Single-center, retrospective cohort analysis of adult patients with warfarin-associated hemorrhage treated with either aPCC or plasma. Patients: Patients received either aPCC or plasma as treatment for warfarin-associated hemorrhage between January 1, 2011, and July 1, 2013. Patients with missing data points were excluded from the final analysis. Of the 276 patients included in the final analysis, 128 received aPCC and 148 received plasma. Interventions: None. Measurements and Main Results: Those patients who received aPCC achieved a lower posttreatment INR (1.1 [0.1] vs 1.6 [0.5]; p<0.05). In addition, patients who received aPCC had a 4.3 times higher odds of achieving an INR of less than 1.4 (97 [75.8%] vs 65 [43.9%]; p<0.05; odds ratio [OR] = 4.3 [95% confidence interval (CI) 2.6–7.3]). When controlling for vitamin K administration, history of diabetes mellitus, receipt of the recommended reversal agent dose, and pretreatment INR, aPCC administration remained an independent predictor for achieving an international normalized ratio (INR) of less than 1.4 in the first 24 hours after treatment (OR = 3.75 [95% CI 2.11–6.65]; p<0.001). In addition, there was no statistical difference between the groups with regard to occurrences of infusion reaction, pulmonary embolism, deep vein thrombosis, stroke, or myocardial infarction. Conclusions: Compared with patients who received plasma, patients who received aPCC achieved a lower posttreatment INR, had a larger INR change, and were more likely to achieve an INR less than the prespecified goal. Those patients who received aPCC did not have a higher incidence of thromboembolic events.

Original languageEnglish (US)
Pages (from-to)1132-1137
Number of pages6
JournalPharmacotherapy
Volume36
Issue number11
DOIs
StatePublished - Nov 1 2016

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Warfarin
International Normalized Ratio
Hemorrhage
Odds Ratio
prothrombin complex concentrates
Confidence Intervals
Vitamin K
Pulmonary Embolism
Venous Thrombosis
Diabetes Mellitus
Cohort Studies
Stroke
Myocardial Infarction
Safety
Incidence

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

Activated Prothrombin Complex Concentrate versus Plasma for Reversal of Warfarin-Associated Hemorrhage. / Rowe, Anthony; Mahbubani, Pinky S.; Bucklin, Mason H.; Clark, Christopher; Hamilton, Leslie.

In: Pharmacotherapy, Vol. 36, No. 11, 01.11.2016, p. 1132-1137.

Research output: Contribution to journalArticle

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title = "Activated Prothrombin Complex Concentrate versus Plasma for Reversal of Warfarin-Associated Hemorrhage",
abstract = "Study Objective: To evaluate the efficacy and safety of an activated four-factor prothrombin complex concentrate (aPCC) versus plasma for the reversal of warfarin-associated hemorrhage. Design: Single-center, retrospective cohort analysis of adult patients with warfarin-associated hemorrhage treated with either aPCC or plasma. Patients: Patients received either aPCC or plasma as treatment for warfarin-associated hemorrhage between January 1, 2011, and July 1, 2013. Patients with missing data points were excluded from the final analysis. Of the 276 patients included in the final analysis, 128 received aPCC and 148 received plasma. Interventions: None. Measurements and Main Results: Those patients who received aPCC achieved a lower posttreatment INR (1.1 [0.1] vs 1.6 [0.5]; p<0.05). In addition, patients who received aPCC had a 4.3 times higher odds of achieving an INR of less than 1.4 (97 [75.8{\%}] vs 65 [43.9{\%}]; p<0.05; odds ratio [OR] = 4.3 [95{\%} confidence interval (CI) 2.6–7.3]). When controlling for vitamin K administration, history of diabetes mellitus, receipt of the recommended reversal agent dose, and pretreatment INR, aPCC administration remained an independent predictor for achieving an international normalized ratio (INR) of less than 1.4 in the first 24 hours after treatment (OR = 3.75 [95{\%} CI 2.11–6.65]; p<0.001). In addition, there was no statistical difference between the groups with regard to occurrences of infusion reaction, pulmonary embolism, deep vein thrombosis, stroke, or myocardial infarction. Conclusions: Compared with patients who received plasma, patients who received aPCC achieved a lower posttreatment INR, had a larger INR change, and were more likely to achieve an INR less than the prespecified goal. Those patients who received aPCC did not have a higher incidence of thromboembolic events.",
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N2 - Study Objective: To evaluate the efficacy and safety of an activated four-factor prothrombin complex concentrate (aPCC) versus plasma for the reversal of warfarin-associated hemorrhage. Design: Single-center, retrospective cohort analysis of adult patients with warfarin-associated hemorrhage treated with either aPCC or plasma. Patients: Patients received either aPCC or plasma as treatment for warfarin-associated hemorrhage between January 1, 2011, and July 1, 2013. Patients with missing data points were excluded from the final analysis. Of the 276 patients included in the final analysis, 128 received aPCC and 148 received plasma. Interventions: None. Measurements and Main Results: Those patients who received aPCC achieved a lower posttreatment INR (1.1 [0.1] vs 1.6 [0.5]; p<0.05). In addition, patients who received aPCC had a 4.3 times higher odds of achieving an INR of less than 1.4 (97 [75.8%] vs 65 [43.9%]; p<0.05; odds ratio [OR] = 4.3 [95% confidence interval (CI) 2.6–7.3]). When controlling for vitamin K administration, history of diabetes mellitus, receipt of the recommended reversal agent dose, and pretreatment INR, aPCC administration remained an independent predictor for achieving an international normalized ratio (INR) of less than 1.4 in the first 24 hours after treatment (OR = 3.75 [95% CI 2.11–6.65]; p<0.001). In addition, there was no statistical difference between the groups with regard to occurrences of infusion reaction, pulmonary embolism, deep vein thrombosis, stroke, or myocardial infarction. Conclusions: Compared with patients who received plasma, patients who received aPCC achieved a lower posttreatment INR, had a larger INR change, and were more likely to achieve an INR less than the prespecified goal. Those patients who received aPCC did not have a higher incidence of thromboembolic events.

AB - Study Objective: To evaluate the efficacy and safety of an activated four-factor prothrombin complex concentrate (aPCC) versus plasma for the reversal of warfarin-associated hemorrhage. Design: Single-center, retrospective cohort analysis of adult patients with warfarin-associated hemorrhage treated with either aPCC or plasma. Patients: Patients received either aPCC or plasma as treatment for warfarin-associated hemorrhage between January 1, 2011, and July 1, 2013. Patients with missing data points were excluded from the final analysis. Of the 276 patients included in the final analysis, 128 received aPCC and 148 received plasma. Interventions: None. Measurements and Main Results: Those patients who received aPCC achieved a lower posttreatment INR (1.1 [0.1] vs 1.6 [0.5]; p<0.05). In addition, patients who received aPCC had a 4.3 times higher odds of achieving an INR of less than 1.4 (97 [75.8%] vs 65 [43.9%]; p<0.05; odds ratio [OR] = 4.3 [95% confidence interval (CI) 2.6–7.3]). When controlling for vitamin K administration, history of diabetes mellitus, receipt of the recommended reversal agent dose, and pretreatment INR, aPCC administration remained an independent predictor for achieving an international normalized ratio (INR) of less than 1.4 in the first 24 hours after treatment (OR = 3.75 [95% CI 2.11–6.65]; p<0.001). In addition, there was no statistical difference between the groups with regard to occurrences of infusion reaction, pulmonary embolism, deep vein thrombosis, stroke, or myocardial infarction. Conclusions: Compared with patients who received plasma, patients who received aPCC achieved a lower posttreatment INR, had a larger INR change, and were more likely to achieve an INR less than the prespecified goal. Those patients who received aPCC did not have a higher incidence of thromboembolic events.

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