PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava Interruption
- Conditions
- Pulmonary EmbolismVenous Thrombosis
- Interventions
- Device: ALN optional filter
- Registration Number
- NCT00457158
- Brief Summary
The purpose of this study is to assess efficacy and safety of optional vena cava filter implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with acute pulmonary embolism associated with thrombotic risk factors
- Detailed Description
Pulmonary embolism is a common pathology, which could be fatal (about 10 000 death/year in France). It mainly originates from a deep vein thrombosis. In order to reduce mortality, prevention of new or recurrent PE is a major therapeutic aim. Only one randomised trial (PREPIC) assessed the interest of a vena cava filter in patients treated by anticoagulant treatment for a deep vein thrombosis (DVT). Results show a significant 50 % reduction of the embolic risk with the filter. This benefit occurs from the first days, but are counterbalanced by a long-term increasing risk of recurrent DVT. The filter appears promising in patients with a high risk of PE, for exemple the elderly, presenting with a thromboembolic history, cancer, heart failure or respiratory insufficiency, or a recent PE. Moreover, retrievable filters, which may be either left in place permanently or retrieved after some days or weeks, could limit the filter thrombosis risk.
The aim of PREPIC 2 study is to assess, in a multicenter randomised trial, efficacy and safety of a retrievable vena cava filter implanted 3 months versus no filter in 400 patients treated with anticoagulant drugs for a symptomatic PE associated with at least one thrombotic risk factor. A clinical follow-up will be performed at 6 months. The primary outcome is the incidence of recurrent PE at 3 months, including symptomatic and fatal PE. It will be adjudicated by an independent committee, blinded to patients' allocation.
This study will assess the benefit risk ratio of the retrievable filter for the prevention of recurrent PE, without increasing the thrombotic risk and the disadvantage due to post thrombotic syndrome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
-
Informed consent
-
Acute symptomatic pulmonary embolism; AND
-
Deep or superficial vein thrombosis; AND
-
At least one of the risk factors below :
- More than 75 years old
- Evolutiv cancer (excepting locally cutaneous cancer)
- Known chronic heart failure treated
- Chronic respiratory insufficiency treated
- Bilateral deep vein thrombosis
- Ilio-cava thrombosis
- Ischemic stroke > 3 days and < 6 months, with lower limb deficit
- Cardiac repercussion of pulmonary embolism assessed by echocardiography or increasing troponin I or T, or Brain Natriuretic Peptid or proBNP
- Contrindication to an anticoagulant treatment or recurrent thromboembolic event despite adequate anticoagulation
- Vena cava filter already inserted
- Filter insertion impossible due to caval thrombosis
- More than 72 hours pre-randomized treatment with therapeutic dosage of anticoagulant therapy
- Non carcinologic surgery within 3 months prior randomization
- Carcinologic surgery within 10 days prior randomization
- Hypersensitivity to contrast media
- Access port in place or programmed within 3 months
- Woman who are child bearing
- Life expectancy < 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ALN optional filter ALN optional filter
- Primary Outcome Measures
Name Time Method at 3 months, combined criteria including recurrent PE confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which PE/DVT can't be ruled out 3 months
- Secondary Outcome Measures
Name Time Method recurrent pulmonary embolism, fatal or not, at 6 months (combined criteria including recurrent pulmonary ambolism confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which P 6 months current or new symptomatic DVT confirmed by objective tests 6 months mecanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter 6 months filter thrombosis 6 months filter retrieval failure 6 months total death 6 months
Trial Locations
- Locations (20)
Unité de Médecine Vasculaire, CHU de Grenoble
🇫🇷Grenoble, France
Service de Pneumologie, Hôpital Antoine Beclere
🇫🇷Clamart, France
Service d'Accueil des Urgences, CHU d'Angers
🇫🇷Angers, France
Service de Médecine Vasculaire, CHU Amiens
🇫🇷Amiens, France
Service de Cardiologie, CHU de Besançon
🇫🇷Besançon, France
Service des Urgences, CHG de Firminy
🇫🇷Firminy, France
CHU de Bordeaux
🇫🇷Bordeaux, France
Département de Medecine Interne et Pneumologie, CHU de Brest
🇫🇷Brest, France
Service d'Accueil des Urgences, CHU de Clermont Ferrand
🇫🇷Clermont Ferrand, France
CHU de Dijon
🇫🇷Dijon, France
Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille
🇫🇷Lille, France
Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier
🇫🇷Montpellier, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Service de Medecine Interne et Vasculaire, CHU de Nancy
🇫🇷Nancy, France
Service de Cardiologie, CHU de Nice
🇫🇷Nice, France
Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP
🇫🇷Paris, France
Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne
🇫🇷Saint-Etienne, France
Service de Cardiologie, CHU de Tours
🇫🇷Tours, France
Service de Medecine et Therapeutique - CHU de Saint-Etienne
🇫🇷Saint-Etienne, France
Service de Médecine Vasculaire, CH Toulon
🇫🇷Toulon, France