(rivaroxaban)
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XARELTO® (rivaroxaban)
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XARELTO - Reversal Agents in Human Studies - PCC - Schulman et al (2018)
Last updated : 05/16/2024
Schulman et al (2018) conducted a prospective, noninterventional, observational, multicenter cohort study to evaluate use of PCC, at a dose of 2000 U, for the management of factor Xa inhibitor–associated major bleeds.1
Study Design1
- Of the 71 patients screened, 66 were included in the study and analyzed for safety and efficacy.
Tranexamic acid (1000 mg) was administered to 17 patients either before or at the time of PCC administration for intracranial bleeding (n=11), GI bleeding (n=3), or other types of bleeding (n=3).1
Efficacy Results
INR and PT were normal in 17 XARELTO-treated patients; however, anti–factor Xa testing performed in 2 of these patients indicated the presence of drug (66-76 ng/mL).1
Anticoagulation was restarted within the 30-day study period at a median of 5 days in 62% (n=41) of patients, including 6 XARELTO-treated patients.1
Hemostatic Effectiveness of PCC1
Ratings
Although effectiveness was rated as good for 26 patients with ICH/intraspinal hemorrhage, 58% of these patients had residual neurological deficit or cognitive impairment. When comparing patients with normal neurological function vs those with residual deficit, there were no significant differences in the median duration from the onset of bleeding, from the last dose of factor Xa inhibitor, or from emergency department arrival to reversal with PCC.1
Safety Results
There were 9 deaths by 30 days (8 with ICH as index event) and 5 major thromboembolic events (diagnosed 1, 2, 9, 12, and 22 days following PCC).1
aTime from the last dose to PCC: 18.1 hours.
bFinal follow-up was performed 30±2 days after treatment with PCC.
aPCC, activated prothrombin complex concentrate; CI, confidence interval; DVT, deep vein thrombosis; GI, gastrointestinal; ICH, intracranial hemorrhage; INR, international normalized ratio; MI, myocardial infarction; PCC, prothrombin complex concentrate; PE, pulmonary embolism; PT, prothrombin time; rFVIIa, recombinant factor VIIa.
aPCC, activated prothrombin complex concentrate; DVT, deep vein thrombosis; MI, myocardial infarction; PCC, prothrombin complex concentrate; PE, pulmonary embolism; rFVIIa, recombinant factor VIIa.
Reference
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1. Schulman S, Gross PL, Ritchie B, et al. Prothrombin complex concentrate for major bleeding on factor Xa inhibitors: a prospective cohort study. Thromb Haemost. 2018;118(5):842-851.
