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

Mismetti, Patrick; Laporte, Silvy; Pellerin, Olivier; Ennezat, Pierre-Vladimir; Couturaud, Francis; Elias, Antoine; Falvo, Nicolas; Meneveau, Nicolas; Quere, Isabelle; Roy, Pierre-Marie; Sanchez, Olivier; Schmidt, Jeannot; Seinturier, Christophe; Sevestre, Marie-Antoinette; Beregi, Jean-Paul; Tardy, Bernard; Lacroix, Philippe; Presles, Emilie; Leizorovicz, Alain; Decousus, Hervé; Barral, Fabrice-Guy; Meyer, Guy.
JAMA; 313(16): 1627-35, 2015 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-25919526
IMPORTANCE: 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.

OBJECTIVE:

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. DESIGN, SETTING, AND PARTICIPANTS: 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.INTERVENTIONS: 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.

MAIN OUTCOMES AND MEASURES:

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.

RESULTS:

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.

CONCLUSIONS AND RELEVANCE:

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.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00457158.
Selo DaSilva