Characteristics and clinical outcomes of Japanese patients with venous thromboembolism receiving under-dose rivaroxaban: subanalysis of J’xactly

References

• ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014; Oct12(10):1580–1590.
   PubMed Web of Science ®Google Scholar
• JCS Joint Working Group. Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2009). Circ J. 2011;75(5):1258–1281.
   PubMedGoogle Scholar
• Raskob GE, Angchaisuksiri P, Blanco AN, et al. Thrombosis: a major contributor to global disease burden. Arterioscler Thromb Vasc Biol. 2014;34(11):2363–2371.
   PubMed Web of Science ®Google Scholar
• Ota S, Matsuda A, Ogihara Y, et al. Incidence, characteristics and management of venous thromboembolism in Japan during 2011. Circ J. 2018;82(2):555–560.
   PubMedGoogle Scholar
• Sakuma M, Nakamura M, Yamada N, et al. Venous thromboembolism: deep vein thrombosis with pulmonary embolism, deep vein thrombosis alone, and pulmonary embolism alone. Circ J. 2009;73(2):305–309.
   PubMed Web of Science ®Google Scholar
• Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149(2):315–352.
   PubMed Web of Science ®Google Scholar
• Wang KL, Yap ES, Goto S, et al. The diagnosis and treatment of venous thromboembolism in Asian patients. Thromb J. 2018;16(4):4.
   PubMedGoogle Scholar
• Yamashita Y, Morimoto T, Amano H, et al. Anticoagulation therapy for venous thromboembolism in the real world- From the COMMAND VTE registry. Circ J. 2018;82(5):1262–1270.
   PubMedGoogle Scholar
• Scaglione F. New oral anticoagulants: comparative pharmacology with vitamin K antagonists. Clin Pharmacokinet. 2013;52(2):69–82.
   PubMed Web of Science ®Google Scholar
• Harder S. Pharmacokinetic and pharmacodynamic evaluation of rivaroxaban: considerations for the treatment of venous thromboembolism. Thromb J. 2014;12:22.
   PubMedGoogle Scholar
• Bauersachs R, Berkowitz SD, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499–2510.
   PubMed Web of Science ®Google Scholar
• Büller HR, Prins MH, Lensin AWA, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287–1297.
   PubMed Web of Science ®Google Scholar
• Prins MH, Lensing AW, Brighton TA, et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014;1(1):e37-46–e46.
   PubMedGoogle Scholar
• Yamada N, Hirayama A, Maeda H, et al. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism – the J-EINSTEIN DVT and PE program. Thromb J. 2015;13(2):2.
   PubMedGoogle Scholar
• Tanigawa T, Kaneko M, Hashizume K, et al. Model-based dose selection for phase III rivaroxaban study in japanese patients with non-valvular atrial fibrillation. Drug Metab Pharmacokinet. 2013;28(1):59–70.
   PubMed Web of Science ®Google Scholar
• Kaneko M, Tanigawa T, Hashizume K, et al. Confirmation of model-based dose selection for a japanese phase III study of rivaroxaban in non-valvular atrial fibrillation patients. Drug Metab Pharmacokinet. 2013;28(4):321–331.
   PubMed Web of Science ®Google Scholar
• Okumura Y, Fukuda I, Nakamura M, 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(11):1912–1921.
   PubMedGoogle Scholar
• Okumura Y, Fukuda I, Nakamura M, 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 Jun 22;8(6):e020286.
   PubMedGoogle Scholar
• Büller HR, Davidson BL, Decousus H, et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003 Oct 30;349(18):1695–1702.
   PubMed Web of Science ®Google Scholar
• Büller HR, Cohen AT, Davidson B, et al. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007;357(11):1094–1104.
   PubMed Web of Science ®Google Scholar
• Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3(4):692–694.
   PubMed Web of Science ®Google Scholar
• Macdonald PS, Kahn SR, Miller N, et al. Short-term natural history of isolated gastrocnemius and soleal vein thrombosis. J Vasc Surg. 2003;37(3):523–527.
   PubMedGoogle Scholar
• Schwarz T, Buschmann L, Beyer J, et al. Therapy of isolated calf muscle vein thrombosis: a randomized, controlled study. J Vasc Surg. 2010;52(5):1246–1250.
   PubMed Web of Science ®Google Scholar
• Righini M, Galanaud JP, Guenneguez H, et al. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016;3(12):e556–e562.
   PubMedGoogle Scholar
• Fernandes CJ, Morinaga LTK, Alves JL, Jr., et al. Cancer-associated thrombosis: the when, how and why. Eur Respir Rev. 2019;28(151):180119.
   PubMed Web of Science ®Google Scholar
• Angchaisuksiri P, Goto S, Farjat AE, et al. Venous thromboembolism in Asia and worldwide: emerging insights from GARFIELD-VTE. Thromb Res. 2021;201:63–72.
   PubMedGoogle Scholar
• Camm AJ, Cools F, Virdone S, et al. Mortality in patients with atrial fibrillation receiving nonrecommended doses of direct oral anticoagulants. J Am Coll Cardiol. 2020; Sep 2276(12):1425–1436.
   PubMed Web of Science ®Google Scholar
• Murata N, Okumura Y, Yokoyama K, et al. Clinical outcomes of off-Label dosing of direct oral anticoagulant therapy among japanese patients with atrial fibrillation identified from the SAKURA AF registry. Circ J. 2019;83(4):727–735.
   PubMed Web of Science ®Google Scholar
• Steinberg BA, Shrader P, Thomas L, et al. Off-label dosing of Non-Vitamin K antagonist oral anticoagulants and adverse outcomes: the ORBIT-AF II registry. J Am Coll Cardiol. 2016;68(24):2597–2604.
   PubMed Web of Science ®Google Scholar
• Prins MH, Lensing AW, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21.
   PubMedGoogle Scholar
• Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8):699–708.
   PubMed Web of Science ®Google Scholar
• Weitz JI, Lensing AWA, Prins MH, et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376(13):1211–1222.
   PubMed Web of Science ®Google Scholar
• Atarashi H, Uchiyama S, Inoue H, et al. Ischemic stroke, hemorrhage, and mortality in patients with non-valvular atrial fibrillation and renal dysfunction treated with rivaroxaban: sub-analysis of the EXPAND study. Heart Vessels. 2021;36(9):1410–1420.
   PubMedGoogle Scholar