Key result
Mixed parenteral and oral anticoagulant lead-in shows similar VTE recurrence to recommended oral regimens.
Why the study?
No evidence exists to support subtracting parenteral anticoagulation days from the total recommended lead-in dosing duration of apixaban or rivaroxaban for VTE treatment.
Does a mixed lead-in regimen (parenteral plus oral) compared to the recommended full oral lead-in regimen affect recurrent VTE and major bleeding in adult patients with acute VTE?
Observational (n=368)
Yes
Does a mixed lead-in regimen (parenteral plus oral) compared to the recommended full oral lead-in regimen affect recurrent VTE and major bleeding in adult patients with acute VTE?
A mixed lead-in regimen subtracting parenteral anticoagulation days from the total lead-in dosing appears as safe and effective as the recommended full oral lead-in duration for apixaban and rivaroxaban in acute VTE.
Mixed lead-in regimens should not yet change VTE practice; hypothesis-generating and leaves open need for RCTs on apixaban/rivaroxaban dosing.
Apixaban and rivaroxaban require lead-in dosing for 7 and 21 days, respectively, when treating venous thromboembolism (VTE). However, no evidence exists to support subtracting parenteral anticoagulation days from total lead-in dosing. A multicenter study was conducted, including adult patients with acute VTE who received apixaban or rivaroxaban. The patients were grouped as follows. The recommended group received oral lead-in anticoagulant for the full recommended duration. The mixed group received lead-in therapy as parenteral with oral anticoagulant. The incidence of recurrent VTE (rVTE) and major bleeding (MB) within 90 days were the main outcomes. Of the 368 included patients, 47.8% received apixaban, and 52.2% received rivaroxaban. The recommended lead-in was used in 296 patients (80.4%), whereas 72 (19.6%) received the mixed-lead-in regimen. Five patients had rVTE events within 90 days; two occurred during hospitalization in the recommended group versus none in the mixed group (0.7% vs. 0.0%; p = 1.000). After discharge, two events occurred in the recommended group and one in the mixed group (0.7% vs. 1.4%; p = 0.481). In terms of MB, 24 events occurred in 21 patients within 90 days. During hospitalization, 11 events occurred in the recommended group and seven in the mixed group (3.7% vs. 9.7%; p = 0.060). After discharge, five more events occurred in the recommended group and one in the mixed group (1.4% vs. 1.7%; p = 1.000). The mixed-lead-in regimen is safe and effective in comparison with the recommended-lead-in regimen.
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Alshaya et al. (2022) conducted an observational in acute venous thromboembolism (VTE) (n=368). Mixed lead-in regimen (parenteral with oral anticoagulant) vs. Recommended lead-in regimen (oral lead-in anticoagulant for the full recommended duration) was evaluated on Incidence of recurrent VTE (rVTE) and major bleeding (MB) within 90 days. A mixed lead-in regimen of parenteral and oral anticoagulants for VTE showed similar rates of recurrent VTE after discharge compared to the recommended oral lead-in regimen (1.4% vs. 0.7%; p=0.481).
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