PREPIC 2
Trial question
What is the role of retrievable IVC filter plus anticoagulation in patients with acute VTE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 399
399 patients (207 female, 192 male).
Inclusion criteria: hospitalized patients with acute, symptomatic PE associated with lower-limb vein thrombosis and at least 1 criterion for severity.
Key exclusion criteria: insertion of a vena cava filter indicated because of a transient or permanent contraindication to anticoagulation therapy or because recurrent thromboembolism had occurred despite adequate anticoagulant therapy, vena cava filter already inserted, noncancer surgery within the past 3 months or cancer surgery within the past 10 days, life expectancy < 6 months, and pregnancy.
Interventions
N=200 IVC filter implantation (filter implantation plus anticoagulation).
N=199 no IVC filter implantation (anticoagulation alone with no filter implantation).
Primary outcome
Symptomatic recurrent pulmonary embolism at 3 months
3%
1.5%
3.0 %
2.3 %
1.5 %
0.8 %
0.0 %
Inferior vena cava filter
implantation
No inferior vena cava filter
implantation
No significant
difference ↔
No significant difference in symptomatic recurrent PE at 3 months (3% vs. 1.5%; RR 2, 95% CI 0.51 to 7.89).
Secondary outcomes
No significant difference in recurrent PE at 6 months, Kaplan-Meier estimates (3.5% vs. 2%; HR 1.78, 95% CI 0.52 to 6.09).
Safety outcomes
No significant difference in major bleeding at 3 months (4% vs. 5%) and major bleeding at 6 months (6.5% vs. 7.5%).
Conclusion
In hospitalized patients with acute, symptomatic PE associated with lower-limb vein thrombosis and at least 1 criterion for severity, IVC filter implantation was not superior to no IVC filter implantation with respect to symptomatic recurrent PE at 3 months.
Reference
Mismetti P, Laporte S, Pellerin O et al. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1627-35.
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