medwireNews: Low-intensity warfarin treatment has not demonstrated noninferiority to standard-intensity warfarin for the prevention of venous thromboembolism (VTE) among older people undergoing hip or knee replacement surgery in a randomized controlled trial.
However, “the trial may have been underpowered to meet this criterion and further research may be warranted,” say Brian Gage (Washington University in St Louis, Missouri, USA) and co-investigators.
As reported in JAMA, 5.1% of the 804 participants aged 65 years or older who were randomly assigned to low-intensity warfarin treatment (international normalized ratio [INR] target=1.8) experienced the primary composite endpoint of VTE within 60 days or death within 30 days, compared with 3.8% of the 793 patients given standard-intensity treatment (INR target=2.5). The between-group difference of 1.3% did not meet prespecified criteria for noninferiority, but the researchers note that “the rate of the primary outcome […] was lower than anticipated.”
Gage and team also found no significant reduction in the risk for major (0.4 vs 0.9%) or non-major clinically relevant (6.6 vs 8.6%) bleeding among patients allocated to low- versus standard-intensity warfarin.
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