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


METHODS
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.


METHODS
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.


METHODS
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
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00457158.
Service de Médecine Vasculaire et Thérapeutique, Centre Hospitalier Universitaire de Saint-Etienne, France2Université Jean Monnet, Groupe d'Investigation et de Recherche Clinique sur la Thrombose, Saint-Etienne, France3Unité de Pharmacologie Clinique, Cen.
Patrick
P
Mismetti
Université Jean Monnet, Groupe d'Investigation et de Recherche Clinique sur la Thrombose, Saint-Etienne, France3Unité de Pharmacologie Clinique, Centre Hospitalier Universitaire de Saint-Etienne, France.
Silvy
S
Laporte
Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, France5Service de Radiologie Interventionnelle, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, France.
Olivier
O
Pellerin
Département de Cardiologie, Centre Hospitalier Universitaire de Grenoble, La Tronche, France.
Pierre-Vladimir
PV
Ennezat
Département de Médecine Interne et Pneumologie, Hôpital La Cavale Blanche, Université De Bretagne occidentale, Brest, France.
Francis
F
Couturaud
Service de Médecine Vasculaire et Médecine Interne, Pôle Cardiologie-Vasculaire, Hôpital Sainte Musse, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer, France.
Antoine
A
Elias
Département de Pathologie Vasculaire, Centre Hospitalier Universitaire Dijon Bocage, France.
Nicolas
N
Falvo
Département de Cardiologie, Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz, Besançon, France.
Nicolas
N
Meneveau
Service de Médecine Vasculaire, Centre Hospitalier Universitaire de Montpellier, Université de Montpellier I, France.
Isabelle
I
Quere
Cardioprotection, Remodelage, et Thrombose and Service des Urgences, Centre Hospitalier Universitaire d'Angers, France 13Université Nantes Angers Le Mans, France.
Pierre-Marie
PM
Roy
Service de Pneumologie, Hôpital Européen Georges Pompidou, Université Paris Descartes, Sorbonne Paris Cité, France.
Olivier
O
Sanchez
Pôle Urgences, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France16Université 1 d'Auvergne, Clermont Ferrand, France.
Jeannot
J
Schmidt
Service de Médecine Vasculaire, Centre Hospitalier Universitaire de Grenoble, France.
Christophe
C
Seinturier
Service de Médecine Vasculaire, Centre Hospitalier Universitaire d'Amiens, France.
Marie-Antoinette
MA
Sevestre
Service de Radiologie, Hôpital Cardiologique, Centre Hospitalier Universitaire de Lille, France.
Jean-Paul
JP
Beregi
Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord, Service Médecine d'Urgences et Réanimation, France21Université de Lyon, Université de Saint-Etienne, France.
Bernard
B
Tardy
Service de Médecine Vasculaire, Centre Hospitalier Universitaire de Limoges, France.
Philippe
P
Lacroix
Unité de Pharmacologie Clinique, Centre Hospitalier Universitaire de Saint-Etienne, France.
Emilie
E
Presles
Unité Mixte de Recherche/Centre National de la Recherche Scientifique, University of Lyon, France.
Alain
A
Leizorovicz
Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord, Service Médecine Vasculaire et Thérapeutique, France.
Hervé
H
Decousus
Service de Radiologie, Centre Hospitalier Universitaire de Saint-Etienne, France 26Université Jean Monnet, Saint-Etienne, France.
Fabrice-Guy
FG
Barral
Université Nantes Angers Le Mans, France.
Guy
G
Meyer
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D020878:Device Removal; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000209:etiology / Q000517:prevention & control*; D012008:Recurrence; D012306:Risk; D018570:Risk Assessment; D016306:Vena Cava Filters; D054556:Venous Thromboembolism / Q000150:complications*
D000925:Anticoagulants