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Device closure benefits patients with PFO, cryptogenic stroke
In patients with cryptogenic stroke and patent foramen ovale, the rate of recurrent stroke appears to be reduced with percutaneously implanted device closure plus medical therapy vs. medical therapy alone, according to a pooled analysis of three trials.
David M. Kent, MD, of Tufts Medical Center, and colleagues evaluated individual patient data on 2,303 participants in three randomized trials that addressed percutaneous PFO closure devices vs. medical therapy in patients with cryptogenic stroke: CLOSURE I, PC and RESPECT. The three trials included data on two devices, the STARFlex umbrella occluder (NMT Medical) and the Amplatzer PFO Occluder (AGA Medical/St. Jude Medical).
The primary outcome was the composite of ischemic stroke, transient ischemic attack or death from any cause. Stroke was defined as the secondary outcome.
Overall, there were 108 composite endpoint events, including 58 ischemic strokes, 54 TIAs and seven deaths. The rate of stroke was 0.98/100 person-years and the composite event rate was 1.8/100 person-years.
For the primary composite outcome, closure did not reach statistical significance in unadjusted analysis (stratified log-rank P = .052; HR = 0.69; 95% CI, 0.47-1.01; P = .053), according to Kaplan-Meier analysis. However, the effects of closure on the composite outcome reached statistical significance in adjusted analyses (HR = 0.68; 95% CI, 0.46-1; P = .049). Similar effects were seen in terms of the secondary composite outcome, with the log-rank test and adjusted Cox analyses showing statistical significance (P = .049 for log-rank test and P = .047 for adjusted Cox regression analysis), and the unadjusted Cox model showing borderline significance (P = .05).
In all analyses of the stroke outcome, the researchers found that device closure plus medical treatment was significantly more effective compared with medical therapy alone, with identical HR estimates revealed in the unadjusted (HR = 0.58; 95% CI, 0.34-0.98) and adjusted analyses (HR = 0.58; 95% CI, 0.34-0.99), according to the researchers.
When analysis was restricted to the two trials involving disc occluder devices, the researchers observed no significant effect of closure for the composite outcome, but a significant difference was observed in the stroke outcome (unadjusted HR = 0.39; P = .013). There was no significant heterogeneity of treatment effects, according to the results.
The HR for atrial fibrillation among patients who underwent closure was threefold higher compared with patients who underwent medical therapy (HR = 3.22; 95% CI, 1.76-5.9). When analysis was limited to the occluder device trials, the HR for AF was 1.85 (95% CI, 0.86-3.98).
The researchers noted that patients with PFO who experience cryptogenic stroke have generally low rates of recurrent cerebral ischemic events with or without closure, but percutaneously implanted device closure yields lower rates of stroke vs. medical therapy alone.
“Longer-term follow-up of ongoing and completed trials will improve our understanding of the comparative effectiveness of closure vs. medical therapy, but comparative studies of various antithrombotic treatment regimens, including those in patients undergoing PFO closure, are needed to address important knowledge gaps,” the researchers wrote. – by Jennifer Byrne
Disclosure: Kent reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.