6/29/23, 1:42 AM PREPIC Pathway Feedback Search Clinical Topics Home Studies PREPIC PREPIC Disease Disease Deep vein thrombosis Pulmonary embolism Trial question What is the effect of vena caval filter in patients with proximal deep vein thrombosis who were at risk for PE? Study design Multi-center Open label RCT Population Characteristics of study participants 52.5% female N = 400 47.5% male 400 patients (210 female, 190 male) Inclusion criteria: patients with proximal deep vein thrombosis who were at risk for PE Key exclusion criteria: placement of a previous filter, contraindication to or failure of anticoagulant therapy, curative anticoagulant therapy lasting > 48 hours, an indication for thrombolysis, short life expectancy, allergy to iodine, hereditary thrombophilia, severe renal or hepatic failure Interventions N=200 IVC filter implantation (insertion immediately after randomization and cavography performed, plus anticoagulation) N=200 no IVC filter implantation (anticoagulation alone with no filter implantation) https://web.pathway.md/studies/recykQg9jas5hkDOH 1/2 6/29/23, 1:42 AM PREPIC Pathway Primary outcome Symptomatic or asymptomatic pulmonary embolism at 12 days 4.8 % 4.8 3.6 % 2.4 % Significant decrease 1.2 % 1.1 NNT = 27 0.0 % Inferior vena cava filter implantation No inferior vena cava filter implantation Significant decrease in symptomatic or asymptomatic PE at 12 days (1.1% vs. 4.8%; OR 0.22, 95% CI 0.05 to 0.9) Secondary outcomes Significant increase in recurrent deep vein thrombosis at 2 years (20.8% vs. 11.6%; OR 1.87, 95% CI 1.1 to 3.2) No significant difference in symptomatic or asymptomatic PE at 12 days (1.6% vs. 4.2%; OR 0.38, 95% CI 0.1 to 1.38) Safety outcomes No significant difference in major bleeding at day 12 or long-term follow-up. Conclusion In patients with proximal deep vein thrombosis who were at risk for PE, IVC filter implantation was superior to no IVC filter implantation with respect to symptomatic or asymptomatic PE at 12 days. Reference Decousus H, Leizorovicz A, Parent F et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Pr vention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409- 15. Open reference URL https://web.pathway.md/studies/recykQg9jas5hkDOH 2/2