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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.

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.

SUBMITTER: Li M

PROVIDER: S-EPMC7526216 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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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.

Li Miaomiao M Zhang Libin L Zhang Kaijie K Zhu Yuefeng Y Shi Zhenyu Z Zhang Wan W Gao Bin B Li Lubin L Fang Zhengdong Z Yin Li L Chen Bing B Liu Zhenjie Z

Trials 20200929 1

<h4>Background</h4>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.<h4>Me ...[more]

PMID: 32993773

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Project description:BackgroundIliac vein compression syndrome (IVCS) is an underlying cause of varicose vein (VV) recurrence after venous surgery. However, the management of recurrent varicose veins (RVVs) combined with IVCS has rarely been reported. This study aimed to investigate the outcomes of a one-stop procedure to correct outflow obstruction and superficial reflux for patients with RVVs and IVCS.MethodsA retrospective analysis was conducted of 102 consecutive patients diagnosed with RVVs. Computed tomography venography (CTV) was performed to confirm IVCS. The cases were divided into 2 groups: the IRVVs group, including patients with RVVs and IVCS (n=48), and the RVVs group, including patients with RVVs only (n=54). The characteristics, vein reflux, and clinical, etiological, anatomical, and pathophysiological (CEAP) distribution were investigated. Then, the IRVVs group patients who underwent endovenous laser ablation (EVLA) (n=39) were divided into a further 2 groups: the EVLA + S group (n=19), who received EVLA and stenting of iliac vein, and the EVLA group (n=20), who received EVLA treatment alone. The great/small saphenous vein (GSV/SSV) trunk occlusion, VV recurrence, visual analogue scale (VAS), and venous clinical severity score (VCSS) were investigated.ResultsThe prevalence rate of femoral vein reflux was 81.2% in IRVVs group and 50% in RVVs group (P<0.05). In the IRVVs group, 72.9% of patients manifested as CEAP clinical class >3, which was higher than that in RVVs group (48.1%) (P<0.05). The 12-month GSV/SSV occlusion rate in the EVLA + S and EVLA groups were 94.7% and 90.0%, respectively. Totals of 9 patients in EVLA + S group and 6 patients in EVLA group had active venous ulcers, and the ulcer healing time in EVLA + S group was significantly shorter (27.22±7.12 vs. 46.67±9.83 days, P<0.05). The reductions in the VAS and VCSS values between baseline, 1 month, and 12 months in the EVLA + S group were more obvious than those in EVLA group (P<0.05).ConclusionsThe one-stop combination treatment of iliac venous stenting and EVLA in patients with RVVs and IVCS is safe and effective and provides prominent symptom relief, improved quality of life, and a more satisfactory ulcer healing than EVLA alone.

Project description:Iliac vein compression syndrome (IVCS) is an important cause of deep vein thrombosis, but the incidence of IVCS is still unclear. The purpose of this prospective study was to determine the incidence of IVCS in an asymptomatic patient population and to evaluate the risk factors in patients with and without IVCS.From October 2011 to November 2012, a total of 500 patients (228 women and 272 men; mean age of 55.4 ± 14.7 years) with no vascular-related symptoms were enrolled in this study. Computed tomography was performed to evaluate all patients. The degree of venous compression was calculated as the diameter of the common iliac vein at the site of maximal compression divided by the mean diameter of the uncompressed proximal and caudal left common iliac vein (LCIV). We compared the stenosis rate of the common iliac vein in women and men according to age and followed up patients to evaluate outcomes.The mean compression degree of the LCIV was 16% (4%, 36%); 37.8% of patients had a compression degree ?25% and 9.8% had a compression degree ?50%. There was a significant difference between men and women in the LCIV compression degree (9% [3%, 30%] vs. 24% [8%, 42%]; U = 4.66, P< 0.01). In addition, the LCIV compression degree among younger women (?40 years) was significantly different compared with that in older women (>40 years) (42% [31%, 50%] vs. 19% [5%, 39%]; U = 5.14, P< 0.001). Follow-up was completed in 367 patients with a mean follow-up of 39.5 months (range, 6-56 months). The incidence of IVCS in the follow-up period was 1.6%. Stenosis rate and the diameter of the site of maximal compression correlated with the incidence of IVCS. Multivariable Cox regression analysis showed that the stenosis rate was an independent risk factor of IVCS (Wald ?2 = 8.84, hazard ratio = 1.13, P< 0.001).The incidence of IVCS was low and correlated with the stenosis rate of iliac vein. Preventative therapy may be warranted for common iliac vein compression in patients at an increased risk of venous thromboembolism, especially patients with a higher iliac vein compression degree.

Project description:PurposeTo assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction.Materials and methodsTwenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months.ResultsFreedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p < 0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at 12 months (p < 0.0001). Primary patency at 36 months was 84% (Kaplan-Meier analysis) while freedom from TVR/TLR was 88.1%. There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported; none adjudicated as device or procedure related.ConclusionThe Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures.Level of evidenceLevel 2-prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature. REGISTRATION CLINICALTRIALS.GOV: Unique Identifier NCT02655887.

Dataset Information

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.

Publications

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.

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