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Randomized Controlled Trial
. 2019 Dec 30;9(1):20356.
doi: 10.1038/s41598-019-56887-w.

Rivaroxaban after Thrombolysis in Acute Iliofemoral Venous Thrombosis: A Randomized, Open-labeled, Multicenter Trial

Jin Mo Kang  1 , Ki-Hyuk Park  2 , Sanghyun Ahn  3   4 , Sungsin Cho  3 , Ahram Han  3 , Taeseung Lee  5 , In Mok Jung  6 , Jang Yong Kim  7 , Seung-Kee Min  8
Affiliations
Randomized Controlled Trial

Rivaroxaban after Thrombolysis in Acute Iliofemoral Venous Thrombosis: A Randomized, Open-labeled, Multicenter Trial

Jin Mo Kang et al. Sci Rep. .

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.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Trial flow.
Figure 3
Figure 3
Efficacy outcome of recurrent venous thromboembolic disease at 6 months. Notes: VTE, venous thromboembolism; VKA, vitamin K antagonist.
Figure 4
Figure 4
Safety outcome of major bleeding or clinically relevant non-major bleeding.
See this image and copyright information in PMC

References

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