麻豆传媒

Percutaneous closure of the patent foramen ovale (PFO) reduced risk of recurrent stroke compared to medical therapy alone, according to two separate meta-analyses pooling the PC, RESPECT, CLOSE, and REDUCE trials.

The first, by Ciro Indolfi, MD, of Italy's Magna Graecia University, and colleagues, found that PFO closure among those have suffered a cryptogenic stroke (TIA) to 3.36% over more than 3 year's follow-up compared with 8.94% with medical management (risk difference -0.029, 95% CI -0.050 to -0.007).

In fact, the larger the interatrial shunt, the more effective PFO closure appeared to be, according to the study published in the Annals of Internal Medicine. PFO closure did increase the risk of new-onset atrial fibrillation (Afib) or atrial flutter, however (4.62% versus 0.85%, risk difference 0.033, 95% CI 0.012-0.054).

"The results of this meta-analysis demonstrate that PFO closure prevents cardioembolic cerebrovascular events in patients with cryptogenic stroke and PFO. This finding represents a positive change in evidence, because three recent randomized trials [PC, RESPECT, CLOSURE I] failed to demonstrate superiority of PFO closure over medical therapy alone," the authors wrote. "Undersizing or inadequate sample sizes initially were blamed for the failure of these trials to demonstrate benefit, but the reasons are probably multifactorial."

Altogether, almost 3,000 participants were included in the meta-analysis.

"We believe that the new evidence warrants a revision of current practice guidelines. In addition, we think this finding of efficacy of PFO closure for patients with cryptogenic stroke might ignite further discussion regarding extending this treatment to primary prevention," Indolfi's group added.

"However, diverging results among single studies suggest that candidates for PFO closure should be selected carefully by using cardiac imaging to maximize clinical benefit and to avoid unnecessary risks for complications," they noted.

A of the same trials, published in the same journal, also suggested that the risk of recurrent stroke fell with PFO closure (1.81% versus 4.57% for medical therapy alone, risk difference -0.032, 95% CI -0.050 to -0.014).

In this analysis, there was no uptick in TIA or major bleeding with either strategy, according to researchers led by Rahman Shah, MD, of University of Tennessee in Memphis. PFO closure was, however, again associated with more new-onset Afib.

"Because recurrent stroke rates are low even with medical therapy alone and PFO closure might affect Afib risk, shared decision making is crucial for this treatment," the authors said.

Shah and colleagues emphasized that the PC, RESPECT, CLOSE, and REDUCE trials differed widely in devices tested and antithrombotic strategy allowed.

FDA-approved in 2016, St. Jude Medical's Amplatzer PFO Occluder was the sole device tested in the PC and RESPECT trials and accounted for more than half of cases in the 11-device CLOSE trial. REDUCE had tested the Gore Helex Septal Occluder and Gore Cardioform Septal Occluder.