Primary outcome
No significant adjusted difference in the 45-day risk of thromboembolism after receiving KCENTRA vs plasma2
TE Events & Mortality
Choose KCENTRA—proven in clinical trials, validated in the real world
Lower all-cause mortality with comparable TE events
- The largest TE and all-cause mortality trial to date
Lower all-cause mortality with comparable TE events
- The largest TE and all-cause mortality trial to date
An FDA postmarketing requirement observational study was conducted in partnership between Kaiser Permanente, CSL Behring, and board-certified physician reviews.2
As presented in the Journal of Thrombosis and Thrombolysis:
“Thromboembolism after treatment with 4-factor prothrombin complex concentrate or plasma for warfarin-related bleeding”
Study design2
- Multicenter, observational study using Kaiser Permanente databases
- Comparison of 45-day risk of TE events in a matched real-world cohort of hospitalized adults
- 2238 patients with no recent history of TE events: KCENTRA (N=1119) or plasma (N=1119)
- Diverse patients across the spectrum of age, sex, race/ethnicity, and socioeconomic status
- Bleeding types included:
68% ICH (N=1514)
31% GI (N=689)
1% other (N=35)
No increased risk of TE events vs plasma
Te Events occurring 45 days following treatment*
In sensitivity analyses, no significant adjusted differences in risk of TE event at 7- and 14-days post-treatment were seen between patients receiving KCENTRA vs plasma.
*aHR: 0.76, 95% CI: 0.49–1.16.
Lower all-cause mortality risk vs plasma
Secondary outcome
Adjusted all-cause mortality risk within 45 days posttreatment was significantly lower in those receiving KCENTRA compared with plasma2
All cause mortality 45 days following treatment†
Risk reduction in adjusted all-cause mortality with KCENTRA vs plasma
In sensitivity analyses, the favorable association of KCENTRA compared with plasma for all-cause mortality was also observed at 7- and 14-days posttreatment
†aHR: 0.59, 95% CI: 0.47–0.73.
While this observational data demonstrated TE event safety, patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Please note the boxed warning regarding arterial and venous thromboembolic complications.
