PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava Interruption (PREPIC2)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase

Completed

Phase 4

Conditions

Pulmonary Embolism

Venous Thrombosis

Treatments

Device: ALN optional filter

Study type

Interventional

Funder types

Other

Identifiers

NCT00457158

2006-01-001

0501105

Details and patient eligibility

About

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

Full 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.

Enrollment

399 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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