Dataset Information

Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol.

ABSTRACT:

Introduction

Inferior vena cava (IVC) filters are commonly used in patients with venous thromboembolism to prevent fatal pulmonary embolism, but the thrombosis risk increases after filter placement. Warfarin is a widely anticoagulant, but long-term monitoring and dose adjustments are required. Anticoagulation with rivaroxaban is more straightforward as it dose not require laboratory monitoring. This study compares the efficacy and safety of rivaroxaban and warfarin as an in anticoagulation therapy for patients with IVC filter placement.

Methods and analysis

This is a multicentre, randomised controlled trial. In total, 200 patients with deep vein thrombosis (DVT) with IVC filter implantation from 10 hospitals will be recruited. The patients will be randomised to the experimental group (rivaroxaban) or the control group (nadroparin overlapped with warfarin). The primary outcomes include death of any cause, pulmonary embolism (PE)-related death, bleeding and recurrent PE/DVT. The secondary outcomes include the percentage of other vascular events, IVC filter retrieval failure and net clinical benefits. This study aims to provide reliable, verification for the efficacy and safety of rivaroxaban antithrombotic therapy after IVC filter placement.

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine (approval number: (2019) 295). The results will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT04066764.

SUBMITTER: Zhang L

PROVIDER: S-EPMC8547359 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol.

Zhang Libin L Li Miaomiao M Zhu Yuefeng Y Shi Zhenyu Z Zhang Wan W Gao Bin B Li Lubin L Fang Zhengdong Z Yang Guangwei G Han Wei W Wang Linjun L Yin Li L Ke Xueying X Yue Jianing J Gu Zheng Z Liu Zhenjie Z

BMJ open 20211025 10

<h4>Introduction</h4>Inferior vena cava (IVC) filters are commonly used in patients with venous thromboembolism to prevent fatal pulmonary embolism, but the thrombosis risk increases after filter placement. Warfarin is a widely anticoagulant, but long-term monitoring and dose adjustments are required. Anticoagulation with rivaroxaban is more straightforward as it dose not require laboratory monitoring. This study compares the efficacy and safety of rivaroxaban and warfarin as an in anticoagulati ...[more]

PMID: 34697109

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Project description:ObjectiveInferior vena cava (IVC) filter placement is associated with important long-term complications. Predictive models for filter-related complications may help guide clinical decision-making but remain limited. We developed machine learning (ML) algorithms that predict 1-year IVC filter complications using preoperative data.MethodsThe Vascular Quality Initiative database was used to identify patients who underwent IVC filter placement between 2013 and 2024. We identified 77 preoperative demographic and clinical features from the index hospitalization when the filter was placed. The primary outcome was 1-year filter-related complications (composite of filter thrombosis, migration, angulation, fracture, and embolization or fragmentation, vein perforation, new caval or iliac vein thrombosis, new pulmonary embolism, access site thrombosis, or failed retrieval). The data were divided into training (70%) and test (30%) sets. Six ML models were trained using preoperative features with 10-fold cross-validation (Extreme Gradient Boosting, random forest, Naïve Bayes classifier, support vector machine, artificial neural network, and logistic regression). The primary model evaluation metric was area under the receiver operating characteristic curve (AUROC). Model robustness was assessed using calibration plot and Brier score. Performance was evaluated across subgroups based on age, sex, race, ethnicity, rurality, median Area Deprivation Index, planned duration of filter, landing site of filter, and presence of prior IVC filter placement.ResultsOverall, 14,476 patients underwent IVC filter placement and 584 (4.0%) experienced 1-year filter-related complications. Patients with a primary outcome were younger (59.3 ± 16.7 years vs 63.8 ± 16.0 years; P < .001) and more likely to have thrombotic risk factors including thrombophilia, prior venous thromboembolism (VTE), and family history of VTE. The best prediction model was Extreme Gradient Boosting, achieving an AUROC of 0.93 (95% confidence interval, 0.92-0.94). In comparison, logistic regression had an AUROC of 0.63 (95% confidence interval, 0.61-0.65). Calibration plot showed good agreement between predicted/observed event probabilities with a Brier score of 0.07. The top 10 predictors of 1-year filter-related complications were (1) thrombophilia, (2) prior VTE, (3) antiphospholipid antibodies, (4) factor V Leiden mutation, (5) family history of VTE, (6) planned duration of IVC filter (temporary), (7) unable to maintain therapeutic anticoagulation, (8) malignancy, (9) recent or active bleeding, and (10) age. Model performance remained robust across all subgroups.ConclusionsWe developed ML models that can accurately predict 1-year IVC filter complications, performing better than logistic regression. These algorithms have potential to guide patient selection for filter placement, counselling, perioperative management, and follow-up to mitigate filter-related complications and improve outcomes.

Dataset Information

Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol.

Similar Datasets

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