Abstract
Recently non-Vitamin K antagonist oral anticoagulants (NOAC) is replacing warfarin for the treatment of deep vein thrombosis (DVT). However, the role of NOAC after thrombolysis of acute iliofeomral DVT (IFDVT) is not yet defined. This randomized clinical trial aimed to compare the safety and efficacy of rivaroxaban versus warfarin after catheter directed thrombolysis of an IFDVT. Patients with acute DVT of both the iliac and the femoral vein (n = 72) were recruited and randomized to either standard anticoagulation (enoxaparin and warfarin, n = 35) or rivaroxaban (n = 37) after successful thrombolysis or mechanical thrombectomy. Primary efficacy outcome was a recurrence of any venous thromboembolism (VTE) within 6 months. Secondary safety outcomes included major bleeding, clinically relevant non-major bleeding (CRNMB), other adverse event, and all-cause mortality. Rate of recurrent VTE were similar in both groups (11.4% versus 12.5%; p = 0.94). Major bleeding or CRNMB was less in rivaroxaban group without significance (2.9% versus 9.4%, HR, 0.31; 95% CI, 0.03–2.96; p = 0.31). Recurrence-free survival and major bleeding-free survival at 6 months were not different in both groups. After thrombolysis of acute IFDVT, rivaroxaban was as safe and effective as warfarin in preventing DVT recurrence.
Highlights
Non-Vitamin K antagonist oral anticoagulants (NOAC) is replacing warfarin for the treatment of deep vein thrombosis (DVT)
The results from the large scale prospective randomized studies[4,5,6,7,8] indicate that non-Vitamin K antagonist oral anticoagulants (NOAC) is non-inferior in efficacy and may be safer than vitamin K antagonist (VKA) as a primary treatment in patients with acute venous thromboembolism, this is not proven in patients after catheter-directed thrombolysis (CDT) as these patient group has been largely excluded in the majority of the trials[5,6,7,8]
The current guidelines recommend that patients managed with CDT be treated with a standard course of conventional anticoagulation after the procedure without specific recommendations made on the type of oral anticoagulants[9,10]
Summary
Non-Vitamin K antagonist oral anticoagulants (NOAC) is replacing warfarin for the treatment of deep vein thrombosis (DVT). The role of NOAC after thrombolysis of acute iliofeomral DVT (IFDVT) is not yet defined This randomized clinical trial aimed to compare the safety and efficacy of rivaroxaban versus warfarin after catheter directed thrombolysis of an IFDVT. The results from the large scale prospective randomized studies[4,5,6,7,8] indicate that NOAC is non-inferior in efficacy and may be safer than VKA as a primary treatment in patients with acute venous thromboembolism, this is not proven in patients after CDT as these patient group has been largely excluded in the majority of the trials[5,6,7,8]. The PRAIS study investigators conducted an open-label, multicenter, randomized study to prove this hypothesis
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