Full-dose or reduced-dose DOACs in high-risk VTE on extended therapy?

In patients with venous thromboembolism (VTE) who needed extended anticoagulation, a reduced dose of direct oral anticoagulants (DOACs) did not meet the non-inferiority criteria for efficacy, compared with full-dose DOACs. However, the event rates were low in both arms. On the other hand, a reduced dose of DOACs was associated with fewer bleeding events than a full dose.

The phase 3 RENOVE trial (NCT03285438) investigated whether a reduced dose of DOACs is a valid option in patients with VTE who need extended anticoagulant therapy [1]. Patients with VTE at high risk of recurrence (n=2,768) received standard anticoagulation therapy for 6–24 months. Hereafter, they were randomised to receive a reduced dose of DOACs (2.5 mg apixaban twice daily or 10 mg rivaroxaban once daily) or a full dose of DOACs (5.0 mg apixaban twice daily or 20 mg rivaroxaban once daily). The primary outcome was adjudicated symptomatic recurrent VTE.

The 5-year cumulative incidence of symptomatic recurrent VTE was 2.2% in the reduced-dose arm and 1.8% in the full-dose arm (adjusted HR 1.32; 95% CI 0.67–2.60; P_{non-inferiority}=0.23). “With these rates, the reduced-dose arm did not meet the trial’s non-inferiority criteria,” explained Prof. Francis Couturaud (Brest University Hospital, France). The corresponding annual incidence rates were 0.50% and 0.40%, respectively. Clinically relevant major bleeding was more common in the full-dose arm than in the reduced-dose arm (15.2% vs 9.9%; adjusted HR 0.61; 95% CI 0.48–0.79). Furthermore, looking at a composite of recurrent VTE or clinically relevant bleeding, the reduced-dose arm appeared to perform better than the full-dose arm (11.8% vs 16.5%; adjusted HR 0.67; 95% CI 0.53–0.86).

“These findings will be useful to strengthen future guidelines and enrich shared decision-making processes for patients with VTE who need extended anticoagulation,” concluded Prof. Couturaud.

1. Couturaud F, et al. Extended treatment of venous thromboembolism with reduced- vs full-dose direct oral anticoagulants in patients at high risk of recurrence. Late-breaking Abstract 3, 66^th ASH Annual Meeting, 7–10 December 2024, San Diego, CA, USA.

Medical writing support was provided by Robert van den Heuvel.

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Posted on 12 December 202412 December 2024