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.
OBJECTIVES: The purpose of this study was to evaluate the necessity of and recommend indications for inferior vena cava (IVC) filter implantation during percutaneous endovenous intervention (PEVI) for deep venous thrombosis (DVT).
BACKGROUND: PEVI has emerged as a powerful tool in the management of acute proximal DVT. Instrumentation of extensive fresh thrombus is potentially associated with iatrogenic pulmonary embolism (PE). The true frequency of this complication has not been studied in a randomized fashion. We evaluated IVC filter implantation during PEVI for DVT.
METHODS: A total of 141 patients with symptomatic proximal DVT undergoing PEVI for symptomatic DVT were randomized to receive an IVC filter (70 patients) or no filter (71 patients; control group). The anticoagulation and PEVI regimen were similar between the two groups. Patients with development of symptoms suggestive of PE underwent objective testing for PE.
RESULTS: PE developed in 1 of the 14 symptomatic patients in the filter group and 8 of the 22 patients in the control group (P = 0.048). There was no mortality in any group. Three patients (4.2%) in the control group had transient hemodynamic instability necessitating resuscitory efforts. Predictors of iatrogenic PE were found to be PE at admission; involvement of two or more adjacent venous segments with acute thrombus; inflammatory form of DVT (severe erythema, edema, pain, and induration); and vein diameter of ≥7 mm with preserved architecture.
CONCLUSIONS: IVC filter implantation during PEVI reduces the risk of iatrogenic PE by eightfold without a mortality benefit. A selective approach may be exercised in filter implantation during PEVI.
<b>BACKGROUND: </b>The benefit of adding a vena cava filter to anticoagulation in treating cancer patients with venous thromboembolism remains controversial. We initiated this study as the first prospectively randomized trial to evaluate the addition of a vena cava filter placement to anticoagulation with the factor Xa inhibitor fondaparinux sodium in patients with cancer.<b>METHODS: </b>Sixty-four patients with deep vein thrombosis (86 %) and/or pulmonary embolism (55 %) were randomly assigned to receive anticoagulation with fondaparinux sodium with or without a vena cava filter. Endpoints included rates of complications by treatment arm, recurrent thromboembolism, complete resolution of thromboembolism, and survival rates.<b>RESULTS: </b>No patient had a recurrent deep vein thrombosis; two (3 %) patients had new pulmonary emboli, one in each randomized cohort. Major bleeding occurred in three patients (5 %). Two patients on the vena cava filter arm (7 %) had complications from the filter. Median survivals were 493 days in the anticoagulation only arm and 266 days for anticoagulation + vena cava filter (p < 0.57). Complete resolution of venous thromboembolism occurred in 51 % of patients within 8 weeks of initiating anticoagulation.<b>CONCLUSIONS: </b>No advantage was found for placement of a vena cava filter in addition to anticoagulation with fondaparinux sodium in terms of safety, recurrent thrombosis, recurrent pulmonary embolism, or survival in this prospective randomized trial evaluating anticoagulation plus a vena cava filter in cancer patients. Favorable complete resolution rates of thrombosis were observed on both study arms.
CONTEXTE: Dans un essai randomisé chez des patients atteints proximale thrombose veineuse profonde, permanents filtres pour veine cave a réduit l'incidence de l'embolie pulmonaire, mais a augmenté celle de la thrombose veineuse profonde à 2 ans. Un 8-années de suivi a été effectuée afin d'évaluer leur très long terme, un effet. MÉTHODES ET RÉSULTATS: Quatre cents patients atteints proximale thrombose veineuse profonde avec ou sans embolie pulmonaire ont été randomisés soit pour recevoir ou non un filtre en plus du traitement anticoagulant de référence pour au moins 3 mois. Les données sur le statut vital, la thromboembolie veineuse, et syndrome post-thrombotique ont été obtenues une fois par an pour un maximum de 8 ans. Tous les événements documentés ont été examinés à l'aveugle par un comité indépendant. Données sur les résultats étaient disponibles dans 396 patients (99%). Embolie pulmonaire symptomatique est survenue chez 9 patients dans le groupe filtre (taux cumulé de 6,2%) et 24 patients (15,1%) dans le groupe sans filtre (P = 0,008). Thrombose veineuse profonde survenue chez 57 patients (35,7%) dans le groupe filtre et 41 (27,5%) dans le groupe sans filtre (P = 0,042). Syndrome post-thrombotique a été observée dans 109 (70,3%) et 107 (69,7%) patients dans les groupes de filtres et de non-filtre, respectivement. À 8 ans, 201 (50,3%) patients étaient décédés (103 et 98 patients dans les groupes de filtres et sans filtre, respectivement). CONCLUSIONS: A 8 ans, filtres pour veine cave réduit le risque d'embolie pulmonaire, mais a augmenté celle de la thrombose veineuse profonde et n'a eu aucun effet sur la survie. Bien que leur utilisation peut être bénéfique chez les patients à haut risque d'embolie pulmonaire, le recours systématique dans la population générale avec une thromboembolie veineuse n'est pas recommandé.
CONTEXTE: L'efficacité et la sécurité des filtres veine cave dans la prévention de l'embolie pulmonaire chez les patients atteints proximale thrombose veineuse profonde est encore un sujet de débat. Méthodes: L'utilisation d'un deux par deux conception factorielle, nous avons assigné au hasard 400 patients avec une thrombose veineuse profonde proximale qui étaient à risque d'embolie pulmonaire à recevoir un filtre à veine cave (200 patients) ou aucun filtre (200 patients), et à recevoir faible poids moléculaire d'héparine (énoxaparine, 195 patients) ou de l'héparine non fractionnée (205 patients). Les taux de thrombo-embolie veineuse récidivante, la mort, et les saignements majeurs ont été analysés au jour 12 et à deux ans. RÉSULTATS: Au jour 12, deux patients assignés à des filtres de réception (1,1 pour cent), comparativement à neuf patients assignés à recevoir aucun filtre (4,8 pour cent), avait eu symptomatique ou asymptomatique embolie pulmonaire (odds ratio, 0,22; intervalle de confiance 95 pour cent, 0,05 à 0,90). A deux ans, 37 patients assignés au groupe de filtres (20,8 pour cent), comparativement à 21 patients assignés au groupe sans filtre (11,6 pour cent), avait eu récurrente thrombose veineuse profonde (odds ratio, 1,87; intervalle de confiance 95 pour cent , 01.10 à 03.20). Il y avait pas de différences significatives dans la mortalité ou les autres résultats. Au jour 12, trois patients du groupe héparine à faible poids moléculaire (1,6 pour cent), comparativement à huit patients du groupe héparine non fractionnée (4,2 pour cent), avait eu symptomatique ou asymptomatique embolie pulmonaire (odds ratio, 0,38; intervalle de confiance 95 pour cent , 0,10 à 1,38). CONCLUSIONS: Dans patients à haut risque avec proximale thrombose veineuse profonde, l'effet initial bénéfique de filtres veine cave pour la prévention de l'embolie pulmonaire a été contrebalancée par un excès de récidive de thrombose veineuse profonde, sans aucune différence dans la mortalité. Nos données ont également confirmé que le faible poids moléculaire d'héparine a été aussi efficace et sûre que l'héparine non fractionnée pour la prévention de l'embolie pulmonaire.
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.
