Five-Year Outcomes of PFO Closure or Antiplatelet Therapy for Cryptogenic Stroke

This correspondence reports five-year outcomes from the Gore REDUCE trial, comparing patent foramen ovale (PFO) closure with antiplatelet therapy in patients with cryptogenic stroke. Among 664 randomized participants (441 to closure; 223 to antiplatelet-only), recurrent stroke occurred in 1.8% of the closure group versus 5.4% of the antiplatelet group over a median 5-year follow-up (hazard ratio: 0.31; 95% CI, 0.13–0.76; P=0.007). No device-related thrombosis, embolization, or fracture was reported during extended follow-up. However, atrial fibrillation or flutter was more frequent post-closure (6.8% vs. 0.4%). The number needed to treat to prevent one stroke over 5 years was approximately 25. Safety profiles were similar across groups, and predictors of arrhythmia remain under investigation via patient-level meta-analysis. These findings reinforce the long-term benefit of PFO closure in selected patients while underscoring the need for careful arrhythmia monitoring.

This correspondence reports five-year outcomes from the Gore REDUCE trial, comparing patent foramen ovale (PFO) closure with antiplatelet therapy in patients with cryptogenic stroke. Among 664 randomized participants (441 to closure; 223 to antiplatelet-only), recurrent stroke occurred in 1.8% of the closure group versus 5.4% of the antiplatelet group over a median 5-year follow-up (hazard ratio: 0.31; 95% CI, 0.13–0.76; P=0.007). No device-related thrombosis, embolization, or fracture was reported during extended follow-up. However, atrial fibrillation or flutter was more frequent post-closure (6.8% vs. 0.4%). The number needed to treat to prevent one stroke over 5 years was approximately 25. Safety profiles were similar across groups, and predictors of arrhythmia remain under investigation via patient-level meta-analysis. These findings reinforce the long-term benefit of PFO closure in selected patients while underscoring the need for careful arrhythmia monitoring.