PREPIC
Trial question
What is the effect of vena caval filter in patients with proximal DVT who were at risk for PE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.5% female
47.5% male
N = 400
400 patients (210 female, 190 male).
Inclusion criteria: patients with proximal DVT who were at risk for PE.
Key exclusion criteria: placement of a previous filter, contraindication to or failure of anticoagulant therapy, curative anticoagulant therapy lasting > 48 hours, an indication for thrombolysis, short life expectancy, allergy to iodine, hereditary thrombophilia, severe renal or hepatic failure.
Interventions
N=200 IVC filter implantation (insertion immediately after randomization and cavography performed, plus anticoagulation).
N=200 no IVC filter implantation (anticoagulation alone with no filter implantation).
Primary outcome
Symptomatic or asymptomatic pulmonary embolism at 12 days
1.1%
4.8%
4.8 %
3.6 %
2.4 %
1.2 %
0.0 %
Inferior vena cava filter
implantation
No inferior vena cava filter
implantation
Significant
decrease ▼
NNT = 27
Significant decrease in symptomatic or asymptomatic PE at 12 days (1.1% vs. 4.8%; OR 0.22, 95% CI 0.05 to 0.9).
Secondary outcomes
Significant increase in recurrent DVT at 2 years (20.8% vs. 11.6%; OR 1.87, 95% CI 1.1 to 3.2).
No significant difference in symptomatic or asymptomatic PE at 12 days (1.6% vs. 4.2%; OR 0.38, 95% CI 0.1 to 1.38).
Safety outcomes
No significant difference in major bleeding at day 12 or long-term follow-up.
Conclusion
In patients with proximal DVT who were at risk for PE, IVC filter implantation was superior to no IVC filter implantation with respect to symptomatic or asymptomatic PE at 12 days.
Reference
Decousus H, Leizorovicz A, Parent F et al. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15.
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