An efficacy and safety study of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation (PLICTS): study protocol for a prospective randomized controlled trial

Miaomiao Li, Libin Zhang, Kaijie Zhang, Yuefeng Zhu, Zhenyu Shi, Wan Zhang, Bin Gao, Lubin Li, Zhengdong Fang, Li Yin, Bing Chen, Zhenjie Liu, Miaomiao Li, Libin Zhang, Kaijie Zhang, Yuefeng Zhu, Zhenyu Shi, Wan Zhang, Bin Gao, Lubin Li, Zhengdong Fang, Li Yin, Bing Chen, Zhenjie Liu

Abstract

Background: Balloon dilatation with stent implantation has been proved to be an effective option for left iliac vein compression syndrome (LIVCS), but thrombosis may still occur after the operation. Currently, warfarin is used for anticoagulant therapy, but long-term monitoring is required, while rivaroxaban does not need laboratory monitoring, which can simplify treatment. Therefore, this study aimed to compare the efficacy and safety of rivaroxaban and warfarin in anticoagulation.

Methods: This study is a multicenter, randomized controlled trial. We will recruit 224 patients with thrombotic LIVCS from 9 hospitals. Moreover, these patients will be randomized to either the experimental group (rivaroxaban) or the control group (warfarin plus nadroparin). The primary outcome is stent occlusion rate. Secondary outcomes are quality of life scale survey results, all-cause mortality, anticoagulation-related mortality, and the proportion of participants with stent displacement/fracture, thrombosis, hemorrhage, and other vascular events.

Discussion: This study will provide reliable, evidence-based clinical evidence for the efficacy and safety of rivaroxaban antithrombotic therapy after stent implantation.

Trial registration: ClinicalTrials.gov NCT04067505 . Registered on August 26, 2019.

Keywords: Left iliac vein compression syndrome; Rivaroxaban; Stent implantation; Thrombotic; Warfarin.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The procedure of screening, randomization, and follow-up of patients in the trial
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments

References

    1. Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965;52:816–821. doi: 10.1002/bjs.1800521028.
    1. May R, Thurner J. The case of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957;8:419–427. doi: 10.1177/000331975700800505.
    1. Chung JW, Yoon CJ, Jung SI, Kim HC, Lee W, Kim YI, et al. Acute iliofemoral deep vein thrombosis: evaluation of underlying anatomic abnormalities by spiral CT venography. J Vasc Interv Radiol. 2004;15:249–256. doi: 10.1097/01.RVI.0000109402.52762.8D.
    1. Oguzkurt L, Tercan F, Pourbagher MA, Kizilkilic O, Turkoz R, Boyvat F. Computed tomography findings in 10 cases of iliac vein compression (May-Thurner) syndrome. Eur J Radiol. 2005;55:421–425. doi: 10.1016/j.ejrad.2004.11.002.
    1. Liu Z, Gao N, Shen L, Yang J, Zhu Y, Li Z, et al. Endovascular treatment for symptomatic iliac vein compression syndrome: a prospective consecutive series of 48 patients. Ann Vasc Surg. 2014;28:695–704. doi: 10.1016/j.avsg.2013.05.019.
    1. Brinegar KN, Sheth RA, Khademhosseini A, Bautista J, Oklu R. Iliac vein compression syndrome: clinical, imaging and pathologic findings. World J Radiol. 2015;7:375–381. doi: 10.4329/wjr.v7.i11.375.
    1. O'Sullivan GJ, Semba CP, Bittner CA, Kee ST, Razavi MK, Sze DY, et al. Endovascular management of iliac vein compression (May-Thurner) syndrome. J Vasc Interv Radiol. 2000;11:823–836. doi: 10.1016/S1051-0443(07)61796-5.
    1. Hurst DR, Forauer AR, Bloom JR, Greenfield LJ, Wakefield TW, Williams DM. Diagnosis and endovascular treatment of iliocaval compression syndrome. J Vasc Surg. 2001;34:106–113. doi: 10.1067/mva.2001.114213.
    1. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest. 2008;133:454s–545s. doi: 10.1378/chest.08-0658.
    1. Hart RG, Diener HC, Yang S, Connolly SJ, Wallentin L, Reilly PA, et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke. 2012;43:1511–1517. doi: 10.1161/STROKEAHA.112.650614.
    1. Eriksson BI, Kakkar AK, Turpie AG, Gent M, Bandel TJ, Homering M, et al. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br Vol. 2009;91:636–644. doi: 10.1302/0301-620X.91B5.21691.
    1. Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009;373:1673–1680. doi: 10.1016/S0140-6736(09)60734-0.
    1. Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499–2510. doi: 10.1056/NEJMoa1007903.
    1. Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, et al. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008;112:2242–2247. doi: 10.1182/blood-2008-05-160143.
    1. Agnelli G, Gallus A, Goldhaber SZ, Haas S, Huisman MV, Hull RD, et al. Treatment of proximal deep-vein thrombosis with the oral direct factor Xa inhibitor rivaroxaban (BAY 59-7939): the ODIXa-DVT (Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients With Acute Symptomatic Deep-Vein Thrombosis) study. Circulation. 2007;116:180–187. doi: 10.1161/CIRCULATIONAHA.106.668020.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Ansell J, Hirsh J, Dalen J, Bussey H, Anderson D, Poller L, et al. Managing oral anticoagulant therapy. Chest. 2001;119:22s–38s. doi: 10.1378/chest.119.1_suppl.22S.
    1. Schulman S, Angerås U, Bergqvist D, Eriksson B, Lassen MR, Fisher W. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thrombosis Haemostasis. 2010;8:202–204. doi: 10.1111/j.1538-7836.2009.03678.x.
    1. Funatsu A, Anzai H, Komiyama K, Oi K, Araki H, Tanabe Y, et al. Stent implantation for May-Thurner syndrome with acute deep venous thrombosis: acute and long-term results from the ATOMIC (AcTive stenting for May-Thurner Iliac Compression syndrome) registry. Cardiovasc Interv Ther. 2019;34:131–138. doi: 10.1007/s12928-018-0532-y.
    1. Ware JE, Kosinski M, Gandek B. SF-36 Health Survey: Manual & Interpretation Guide. 2005.
    1. Radaideh Q, Patel NM, Shammas NW. Iliac vein compression: epidemiology, diagnosis and treatment. Vasc Health Risk Manag. 2019;15:115–122. doi: 10.2147/VHRM.S203349.
    1. Husmann MJ, Heller G, Kalka C, Savolainen H, Do DD, Schmidli J, et al. Stenting of common iliac vein obstructions combined with regional thrombolysis and thrombectomy in acute deep vein thrombosis. Eur J Vasc Endovasc Surg. 2007;34:87–91. doi: 10.1016/j.ejvs.2007.01.006.
    1. Matsuda A, Yamada N, Ogihara Y, Tsuji A, Ota S, Ishikura K, et al. Early and long-term outcomes of venous stent implantation for iliac venous stenosis after catheter-directed thrombolysis for acute deep vein thrombosis. Circ J. 2014;78:1234–1239. doi: 10.1253/circj.CJ-13-1247.
    1. Kim IS, Jo WM, Chung HH, Lee SH. Comparison of clinical outcomes of pharmaco-mechanical thrombectomy in iliac vein thrombosis with and without May-Thurner syndrome. Int Angiol. 2018;37:12–18.
    1. Hanafy AS, Abd-Elsalam S, Dawoud MM. Randomized controlled trial of rivaroxaban versus warfarin in the management of acute non-neoplastic.portal vein thrombosis. Vascul Pharmacol. 2019;113:86-91.
    1. Beyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, et al. Prevention of thromboembolic complications in patients withsuperficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017;4:e105-e113.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться