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

Patrick Mismetti 1, 2, 3 Silvy Laporte 1, 3 Olivier Pellerin 4, 5 Pierre-Vladimir Ennezat 6 Francis Couturaud 7, 8 Antoine Elias 9 Nicolas Falvo 10 Nicolas Meneveau 11 Isabelle Quere 12 Pierre-Marie Roy 13 Olivier Sanchez Jeannot Schmidt 14 Christophe Seinturier 15 Marie-Antoinette Sevestre Jean-Paul Beregi 16, 17 Bernard Tardy 1 Philippe Lacroix 18, 19 Emilie Presles 3 Alain Leizorovicz 20 Hervé Decousus 1, 21 Fabrice-Guy Barral Guy Meyer 22
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.
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Journal of the American Medical Association, American Medical Association (AMA), 2015, 313 (16), pp.1627-35. 〈10.1001/jama.2015.3780〉
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Soumis le : mercredi 17 février 2016 - 12:04:38
Dernière modification le : mercredi 28 février 2018 - 17:04:02

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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, American Medical Association (AMA), 2015, 313 (16), pp.1627-35. 〈10.1001/jama.2015.3780〉. 〈hal-01275317〉

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