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VascularClassic Trial

PREPIC 2 (2015)

JAMA·2015
Negative TrialClassic
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AI-Generated Summary

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Background

The role of retrievable inferior vena cava (IVC) filters in patients with acute pulmonary embolism (PE) who are at high risk of recurrence or contraindication to anticoagulation was unclear. Prior studies suggested a benefit in VTE prevention but were limited by design. This study aimed to determine if temporary IVC filters reduce PE recurrence or mortality in high-risk PE patients.

Study Design

PREPIC 2 was a multicenter, open-label, randomized controlled trial conducted in France, enrolling 400 patients with acute PE and at least one criterion for severe PE or contraindication to anticoagulation. Patients were randomized to receive a retrievable IVC filter plus anticoagulation (if not contraindicated) or anticoagulation alone. The primary endpoint was a composite of fatal or nonfatal recurrent PE at 3 months.

Key Findings

The study found no significant difference in the primary endpoint between the filter group and the control group. Recurrent PE or PE-related death occurred in 6.3% of the filter group versus 7.1% of the control group (relative risk, 0.88; 95% CI, 0.45-1.71; P=0.70). All-cause mortality was also similar (11.0% vs 14.7%, P=0.26). No significant benefit was observed even in the subgroup of patients with contraindications to anticoagulation.

Clinical Bottom Line

Temporary IVC filters do not reduce the risk of recurrent PE or PE-related death in patients with acute PE, even in those considered high-risk or with contraindications to anticoagulation.

Limitations & Caveats

The study was open-label, which could introduce bias, and the overall event rate was lower than anticipated. The generalizability to all high-risk PE patients, especially those with massive PE, might be limited.

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