Effectiveness of patent foramen ovale occlusion devices versus medical therapy: An indirect comparison based on reconstructed individual patient data.

BACKGROUND

Percutaneous closure of patent foramen ovale (PFO) reduces the risk of recurrent stroke in selected patients with cryptogenic stroke. However, direct comparative data among different occlusion devices are lacking.

OBJECTIVE

Our study aimed to compare the efficacy PFO closure plus medical therapy versus medical therapy alone in patients with cryptogenic stroke using data from randomized controlled trials (RCTs).

METHODS

Randomized controlled trials with ≥36 months of follow-up evaluating PFO closure with Abbott or Gore devices versus medical therapy were identified. Individual patient data were reconstructed from published Kaplan-Meier curves using the IPDfromKM artificial intelligence-based method. Time-to-event analyses were performed using hazard ratios (HRs) with 95% confidence intervals (CIs). Between-trial heterogeneity was assessed on control arms.

RESULTS

Three randomized trials were included. No significant heterogeneity was observed among medical therapy control groups. When all devices were pooled, PFO closure significantly reduced recurrent stroke compared with medical therapy alone (HR 0.4288; 95%CI, 0.2533 to 0.7258; p = 0.0016). Both Abbott devices (HR 0.4631 (95% CI, 0.2597 to 0.8258; p = 0.00909) and Gore devices (HR= 0.3457 (95%CI, 0.1354 to 0.8826) were associated with a significantly lower risk of recurrent stroke. The indirect comparison between devices showed no significant difference.

CONCLUSIONS

In this indirect comparison based on reconstructed individual patient data, PFO closure with occlusion devices significantly reduced recurrent stroke compared with medical therapy alone. Abbott and Gore devices demonstrated comparable long-term efficacy.