DOACs were associated with fewer major bleedings (1.8%/yr vs 3.1%/yr; P=0.003) and fatal bleedings (0.1%/yr vs 0.3%/yr; P=0.02) than standard initial treatment, though CFR of recurrent VTE was similar.
Meta-Analysis (n=35,029)
Do DOACs improve the case fatality rate of recurrent VTE and bleeding compared to standard therapy or placebo in patients with VTE?
DOACs are associated with fewer major and fatal bleeding events than standard initial VTE treatment, and lower mortality and recurrent VTE than placebo during extended therapy.
Absolute Event Rate: 16% vs 13%
p-value: p=0.61
BACKGROUND: In patients with venous thromboembolism (VTE), the study of the case fatality rate (CFR) of VTE recurrences and bleeding complications may be of help to balance the risks and benefits of anticoagulant therapy. OBJECTIVE: To investigate the CFR with the direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban) in patients with VTE. METHODS: We conducted a systematic review and meta-analysis of randomized clinical trials testing the DOACs versus standard initial treatment of VTE (parenteral anticoagulant for ≥5 days plus vitamin K antagonists VKAs for ≥3 months) and DOACs versus placebo or VKA for extended treatment. Two investigators independently extracted the data. A random effects meta-analysis was conducted using StatsDirect software. RESULTS: Overall, 10 trials in 35 029 patients were included. During initial treatment, the rate of recurrent VTE per 100 patient-years (%/yr) and CFR (%) was similar in patients receiving DOACs or standard therapy (4.1%/yr vs 4.4%/yr; P = .21 and 16% vs 13%; P = .61, respectively). However, major bleeding (1.8%/yr vs 3.1%/yr; P = .003), fatal bleeding (0.1%/yr vs 0.3%/yr; P = .02), and CFR (6% vs 10%; P = .18) were lower with DOACs than with standard therapy. During extended treatment, both all-cause mortality and recurrent VTE per 100 patient-years were lower with DOACs than with placebo (0.6%/yr vs 1.1%/yr; P = .01 and 1.9%/yr vs 10.9%/yr; P < .0001, respectively), but there were no statistical differences between treatments on CFR of VTE recurrences (P = .17). No fatal bleeding events were reported during extended treatment. CONCLUSION: The use of DOACs was associated with fewer major and fatal bleedings and corresponding CFR than standard initial treatment of VTE, and fewer recurrent VTEs and mortality than placebo during extended therapy, although the CFR of recurrent VTE was not reduced.
Gómez‐Outes et al. (Mon,) conducted a meta-analysis in Venous thromboembolism (VTE) (n=35,029). Direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban) vs. Standard initial treatment (parenteral anticoagulant plus vitamin K antagonists) or placebo/VKA for extended treatment was evaluated on Case fatality rate (CFR) of VTE recurrences during initial treatment (p=0.61). DOACs were associated with fewer major bleedings (1.8%/yr vs 3.1%/yr; P=0.003) and fatal bleedings (0.1%/yr vs 0.3%/yr; P=0.02) than standard initial treatment, though CFR of recurrent VTE was similar.
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