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

• 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  

• 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• current or new symptomatic DVT confirmed by objective tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• mecanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• filter thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• filter retrieval failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• total death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  

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.