Key result
Rivaroxaban was as effective as standard anticoagulation with warfarin in preventing venous thromboembolism recurrence after successful thrombolysis for acute iliofemoral deep vein thrombosis (11.4% vs 12.5%; HR 0.95).
Why the study?
NOACs are replacing warfarin for DVT treatment, but their role following thrombolysis of acute iliofemoral DVT was not yet defined.
Does rivaroxaban prevent recurrent venous thromboembolism as effectively and safely as warfarin in patients with acute iliofemoral deep vein thrombosis after successful catheter-directed thrombolysis?
RCT (n=72)
Open-label
Permuted block randomization with blocks of sizes 4 or 6
Yes
Does rivaroxaban prevent recurrent venous thromboembolism as effectively and safely as warfarin in patients with acute iliofemoral deep vein thrombosis after successful catheter-directed thrombolysis?
Hazard Ratio: 0.95 (95% CI 0.24–3.79)
Absolute Event Rate: 11.4% vs 12.5%
p-value: p=0.94
Rivaroxaban is as effective and safe as standard warfarin therapy for preventing DVT recurrence after successful catheter-directed thrombolysis in patients with acute iliofemoral DVT.
Rivaroxaban offers comparable safety and efficacy to warfarin after IFDVT thrombolysis; extends NOAC evidence to this post-intervention setting.
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.
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Kang et al. (2019) conducted an RCT in Acute iliofemoral venous thrombosis (n=72). Rivaroxaban vs. Standard therapy (enoxaparin and vitamin K antagonist/warfarin) was evaluated on Recurrence of any venous thromboembolism (VTE) within 6 months (HR 0.95, 95% CI 0.24-3.79, p=0.94). Rivaroxaban was as effective as standard anticoagulation with warfarin in preventing venous thromboembolism recurrence after successful thrombolysis for acute iliofemoral deep vein thrombosis (11.4% vs 12.5%; HR 0.95).
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