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

doi:10.1186/s13063-020-04742-z

Abstract

BackgroundBalloon 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.MethodsThis 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.DiscussionThis study will provide reliable, evidence-based clinical evidence for the efficacy and safety of rivaroxaban antithrombotic therapy after stent implantation.Trial registrationClinicalTrials.gov NCT04067505. Registered on August 26, 2019.

Highlights

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
Left iliac vein compression syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar vertebra, which results in blood flow disorders in lower limbs and pelvic veins
While as a result of vein intima defect or direct injury, residual thrombus and the stimulus of the stent, thrombosis may be induced after stent implantation

Summary

Introduction

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. Left iliac vein compression syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar vertebra, which results in blood flow disorders in lower limbs and pelvic veins. It is called Cockett syndrome [1] or MayThurner syndrome [2]. Left iliac vein balloon dilatation with stent implantation has been used to treat patients with LIVCS and have achieved good results [7, 8]

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