Effectiveness and safety of the direct oral anticoagulant in acute distal deep vein thrombosis: From the prospective multicenter observational study,J’xactly,in Japan

Abstract

Objectives

We assessed the effectiveness and safety of rivaroxaban in patients with isolated distal deep vein thrombosis (IDDVT).

Methods

Symptomatic venous thromboembolism (VTE) and major bleeding were assessed.

Results

Of 1016 patients with acute symptomatic/asymptomatic DVT and/or pulmonary embolism treated with rivaroxaban, 288 had IDDVT and 294 had proximal DVT (pDVT). The IDDVT group had fewer patients on the higher rivaroxaban dose (30 mg/day) (42.7% vs. 66.0%) and a shorter treatment duration (135.5 vs 369.5 days) than the pDVT group. VTE recurrence occurred in 14 and 11 patients with IDDVT and pDVT, respectively (2.89% vs. 2.29% per patient-year; p = 0.534). Major bleeding was less frequent in the IDDVT group (1.55% vs. 4.53% per patient-year; p = 0.044). Comparable effectiveness and safety were observed with 15 and 30 mg/day rivaroxaban in the IDDVT group.

Conclusions

Short-term, low-dose rivaroxaban seems safe and effective for IDDVT treatment.

Keywords

Deep vein thrombosis pulmonary embolism real-world survey rivaroxaban isolated distal deep vein thrombosis

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References

Nabel

. Message from the Director of the National, Heart, Lung, and Blood Institute, National Institutes of Health. In: Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Rockville (MD): Office of the Surgeon General (US), 2008.

Kearon

. Natural history of venous thromboembolism. Circulation 2003; 107: I22–I130.

Satokawa

Yamaki

Iwata

, et al. The survey of deep vein thrombosis and venous thromboembolism prevention: Japanese vein study XIII. Jpn J Phlebol 2012; 23: 271–281.

Stevens

Woller

Kreuziger

, et al. Antithrombotic therapy for VTE disease: second update of the CHEST guideline and expert panel report. Chest 2021; 160: e545-e608.

Kearon

Akl

Comerota

, et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9^th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141: e419S-e496S.

Horner

Hogg

Body

, et al. The anticoagulation of calf thrombosis (ACT) project: results from the randomized controlled external pilot trial. Chest 2014; 146: 1468–1477.

Schwarz

Buschmann

Beyer

, et al. Therapy of isolated calf muscle vein thrombosis: a randomized, controlled study. J Vasc Surg 2010; 52: 1246–1250.

Franco

Giustozzi

Agnelli

, et al. Anticoagulation in patients with isolated distal deep vein thrombosis: a meta-analysis. J Thromb Haemost 2017; 15: 1142–1154.

Bauersachs

Berkowitz

Brenner

, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499–2510.

10.

Investigators

Hokusai-VTE

Büller

Décousus

, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013; 369: 1406–1415.

11.

Agnelli

Buller

Cohen

, et al; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369: 799–808.

12.

Okumura

Fukuda

Nakamura

, et al. A multicenter prospective observational cohort study to investigate the effectiveness and safety of rivaroxaban in Japanese venous thromboembolism patients (The J’xactly Study). Circ J 2020; 84: 1912–1921.

13.

Okumura

Fukuda

Nakamura

, et al. Design and rationale for the Japanese Registry of Rivaroxaban Effectiveness & Safety for the Prevention of Recurrence in Patients with Deep Vein Thrombosis and Pulmonary Embolism (J’xactly) study. BMJ Open 2018; 8: e020286.

14.

Buller

Cohen

Davidson

, et al. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 2007; 357: 1094–1104.

15.

Buller

Davidson

Decousus

, et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med 2003; 349: 1695–1702.

16.

Schulman

Kearon

Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis . Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692–694.

17.

The Japanese Circulation Society . Guidelines for diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2017), https://www.j-circ.or.jp/cms/wp-content/uploads/2017/09/JCS2017_ito_h.pdf

18.

Philbrick

Becker

. Calf deep venous thrombosis. A wolf in sheep’s clothing? Arch Intern Med 1988; 148: 2131–2138.

19.

Macdonald

Kahn

Miller

, et al. Short-term natural history of isolated gastrocnemius and soleal vein thrombosis. J Vasc Surg 2003; 37: 523–527.

20.

Palareti

Cosmi

Lessiani

, et al. Evolution of untreated calf deep-vein thrombosis in high risk symptomatic outpatients: the blind, prospective CALTHRO study. Thromb Haemost 2010; 104: 1063–1070.

21.

Shimabukuro

Hashiyana

, et al. Clinical course of asymptomatic isolated distal deep vein thrombosis of the leg: a single-institution study. Jpn J Phlebol 2018; 29: 309–314.

22.

Yamashita

Shiomi

Morimoto

, et al. Asymptomatic lower extremity deep vein thrombosis – clinical characteristics, management strategies, and long-term outcomes. Circ J 2017; 81: 1936–1944.

23.

Righini

Galanaud

Guenneguez

, et al. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol 2016; 3: e556–e562.

24.

Garry

Duke

Labropoulos

. Systematic review of the complications following isolated calf deep vein thrombosis. Br J Surg 2016; 103: 789–796.

25.

Tritschler

Kraaijpoel

Le Gal

, et al. Venous thromboembolism: advances in diagnosis and treatment. JAMA 2018; 320: 1583–1594.

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