Key result
Postoperative bleeding occurred significantly more frequently in real-world patients receiving rivaroxaban after joint arthroplasty compared to patients in the RECORD trials (6.8% vs 3.2%, P<0.0001).
Why the study?
Does rivaroxaban use in real-world clinical practice increase postoperative bleeding compared to clinical trial data in patients undergoing THA or TKA?
Cohort (n=6,623)
Yes
Does rivaroxaban use in real-world clinical practice increase postoperative bleeding compared to clinical trial data in patients undergoing THA or TKA?
Absolute Event Rate: 6.8% vs 3.2%
p-value: p=<0.0001
Real-world postoperative bleeding rates with rivaroxaban after THA and TKA were significantly higher than those reported in the pivotal RECORD clinical trials.
May warrant caution with rivaroxaban after arthroplasty outside trials; challenges RECORD generalizability and leaves open need for prospective validation.
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Wood et al. (2015) conducted a cohort in Total hip and total knee arthroplasty (n=6,623). Rivaroxaban in clinical practice vs. Rivaroxaban in RECORD 1-4 trials was evaluated on Occurrence of any postoperative bleeding (composite of major and clinically relevant nonmajor bleeding) (p=<0.0001). Postoperative bleeding occurred significantly more frequently in real-world patients receiving rivaroxaban after joint arthroplasty compared to patients in the RECORD trials (6.8% vs 3.2%, P<0.0001).
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