Noninferiority of reduced-dose anticoagulants could not be proven in patients with VTE who need extended anticoagulation
By Elana Gotkine HealthDay Reporter
FRIDAY, Dec. 6, 2024 (HealthDay News) — Noninferiority of reduced- versus full-dose anticoagulants cannot be proven in patients with venous thromboembolism who need extended anticoagulation, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
Francis Couturaud, M.D., Ph.D., from the University of Brest in France, and colleagues conducted a multicenter, prospective, randomized trial comparing extended anticoagulation with reduced-dose versus full-dose direct oral anticoagulants in patients with venous thromboembolism at high risk for recurrence, who were initially treated for six to 24 months.
The researchers found that recurrent venous thromboembolism occurred in 19 of 1,383 patients in the reduced-dose group versus 15 of 1,385 in the full-dose group during the 36-month median follow-up (five-year cumulative incidence, 2.2 versus 1.8 percent; hazard ratio, 1.32; 95 percent confidence interval, 0.67 to 2.60; P = 0.23 for noninferiority). Clinically relevant bleeding occurred in 96 patients in the reduced-dose group and 154 in the full-dose group (five-year cumulative incidence, 9.9 versus 15.2 percent). The composite outcome of recurrent venous thromboembolism and clinically relevant bleeding occurred in 113 and 166 patients in the reduced- and full-dose groups, respectively (five-year cumulative incidence, 11.8 versus 16.5 percent). All-cause death occurred in 4.3 and 6.1 percent of patients in the reduced- and full-dose groups, respectively.
“The noninferiority of a reduced-dose versus a full-dose of direct anticoagulants to prevent recurrent venous thromboembolism could not be proven,” the authors write.
Several authors disclosed ties to the pharmaceutical industry.
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