Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial. - Université de Bretagne Occidentale Access content directly
Journal Articles Journal of the American Medical Association Year : 2015

Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial.

1 GRT - Groupe de recherche sur la thrombose, pharmacologie des antithrombotiques et situations à risque
2 Service de Médecine Vasculaire et Thérapeutique
3 Pharmaco Clin - SAINT ETIENNE - Unité de Pharmacologie Clinique
4 Service de Radiologie Cardiovasculaire Diagnostique et Interventionnelle
5 UPD5 Médecine - Université Paris Descartes - Faculté de Médecine
6 Département de cardiologie et hypertension
7 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]
8 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale
9 Med Vasc - Med Int - LA SEYNE SUR MER - Service de Médecine Vasculaire et Médecine Interne
10 Service de chirurgie cardio-vasculaire et thoracique (CHU Dijon)
11 Service de cardiologie [CHRU de Besançon]
12 Med Vasc - MONTPELLIER - Service de Médecine Vasculaire
13 EA 2992 - Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires
14 CHU d'Angers [Département Urgences]
15 Technion - Israel Institute of Technology [Haifa]
16 unité de médecine vasculaire
17 Department of Plastic and Craniofacial Pediatric Surgery
18 Department of Radiology
19 AIDMP - Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415
20 Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges]
21 NET - Neuroépidémiologie Tropicale
22 UCBL - Université Claude Bernard Lyon 1
23 CIC-EC 1408 - Centre d'Investigation Clinique - Epidémiologie Clinique [CHU Saint-Etienne]
24 PARCC - UMR-S U970 - Paris-Centre de Recherche Cardiovasculaire
Olivier Sanchez
Marie-Antoinette Sevestre
Fabrice-Guy Barral
  • Function : Author

Abstract

Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism, their benefit-risk ratio is unclear. To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence. Randomized, open-label, blinded end point trial (PREPIC2) with 6-month follow-up conducted from August 2006 to January 2013. Hospitalized patients with acute, symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least 1 criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation (filter group; n = 200) or anticoagulation alone with no filter implantation (control group; n = 199). Initial hospitalization with ambulatory follow-up occurred in 17 French centers. Full-dose anticoagulation for at least 6 months in all patients. Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group. Filter retrieval was planned at 3 months from placement. Primary efficacy outcome was symptomatic recurrent pulmonary embolism at 3 months. Secondary outcomes were recurrent pulmonary embolism at 6 months, symptomatic deep vein thrombosis, major bleeding, death at 3 and 6 months, and filter complications. In the filter group, the filter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted. By 3 months, recurrent pulmonary embolism had occurred in 6 patients (3.0%; all fatal) in the filter group and in 3 patients (1.5%; 2 fatal) in the control group (relative risk with filter, 2.00 [95% CI, 0.51-7.89]; P = .50). Results were similar at 6 months. No difference was observed between the 2 groups regarding the other outcomes. Filter thrombosis occurred in 3 patients. Among hospitalized patients with severe acute pulmonary embolism, the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months. These findings do not support the use of this type of filter in patients who can be treated with anticoagulation. clinicaltrials.gov Identifier: NCT00457158.

Dates and versions

hal-01275317 , version 1 (17-02-2016)

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Patrick Mismetti, Silvy Laporte, Olivier Pellerin, Pierre-Vladimir Ennezat, Francis Couturaud, et al.. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial.. Journal of the American Medical Association, 2015, 313 (16), pp.1627-35. ⟨10.1001/jama.2015.3780⟩. ⟨hal-01275317⟩
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