PFO closure equivalent to medical management in prevention of recurrent stroke [PC and RESPECT trials]

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Image: PD

1. For patients with a previous cryptogenic stroke and found to have a patent foramen ovale (PFO), there is no benefit to PFO closure vs. medical-therapy alone in secondary prevention and mortality. 

2. In both the PC and RESPECT trials, the rates of major adverse events did not differ between the two randomized groups. 

Published today: For patients with cryptogenic stroke and later found to have a patent foramen ovale (PFO), PFO closure is equivalent to medical therapy in secondary prevention. Furthermore, in both studies, the major adverse events including atrial fibrillation, myocardial infarction and bleeding were also similar in both randomized groups.

Previous studies have shown that PFO closure provides a risk reduction in recurrent strokes, however, another meta-analysis suggested that adverse events from PFO closure leads to worse outcomes than medical therapy alone. These two studies do not provide any additional evidence in support of PFO closure for patients with cryptogenic stroke or peripheral embolism.

Although common risk factors for cardiovascular disease were well controlled among the groups in both studies, the average age of patients in both studies was young (44 in the PC trial, 45.9 in the RESPECT trial). Therefore, a major limitation of this study is that these conclusions cannot be generalized to elderly patients (over the age of 65).  The effect sizes, although not statistically significant, favor closure, suggesting that the studies might have been underpowered to detect a true difference. Future analyses are required to study long-term outcomes and further inform the debate over PFO management.

Click here to read about the PC trial in NEJM

Click to read about the RESPECT trial in NEJM

Click to read an accompanying editorial in NEJM

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1. For patients with a previous cryptogenic stroke and found to have a PFO, there is no benefit to PFO closure versus medical-therapy only (using antiplatelet agents and/or anticoagulants) in secondary prevention and mortality as shown by the PC and RESPECT trials.

2. In both the PC and RESPECT trials, the rates of major adverse events did not differ between the two randomized groups.

These [randomized] trials: The PC trial was a [multi-center, randomized control] study comparing the outcome in 414 patients with a prior crytogenic stroke or embolism and a patent foramen ovale (PFO). Participants were randomized to either PFO closure with the Amplatzer PFO occluder or medical therapy (ie. a combination of antiplatelet agents and/or anticoagulants left to the discretion the physician). The primary endpoint was a composite of death, nonfatal stroke, TIA or peripheral embolism at the end of a four year follow up period and there was no significance in this endpoint between the PFO closure vs. medical therapy group (3.4% vs. 5.2%, hazard ratio with closure 0.63, confidence interval 0.24 – 1.62, p=0.34).

The RESPECT trial was a [multi-center, randomized] control study comparing the outcome of 980 patients with cryptogenic stroke in 69 sites between the ages of 18 to 60 years. Participants were randomized to either PFO closure with the Amplatzer PFO occluder or one of four medical-therapy groups (aspirin, warfarin, clopidogrel, aspirin combined with clopidegrel). The primary end point was a composite of nonfatal ischemic stroke, fatal ischemic stroke or early death after randomization. Patients were consistently evaluated for a period of up to two years. All 25 primary end point events were nonfatal ischemic strokes and there was no significant between the PFO closure vs. medical therapy groups (1.8% vs. 3.3%, hazard ratio 0.49, confidence interval 0.22 – 1.11, p=0.08).

In sum:  For patients with cryptogenic stroke and later found to have a patent foramen ovale (PFO), PFO closure is equivalent to medical therapy in secondary prevention. Furthermore, in both studies, the major adverse events including atrial fibrillation, myocardial infarction and bleeding were also similar in both randomized groups.

Previous studies have shown that PFO closure provides a risk reduction in recurrent strokes, however, another meta-analysis suggested that adverse events from PFO closure leads to worse outcomes than medical therapy alone. These two studies do not provide any additional evidence in support of PFO closure for patients with cryptogenic stroke or peripheral embolism.

Although common risk factors for cardiovascular disease were well controlled among the groups in both studies, the average age of patients in both studies was young (44 in the PC trial, 45.9 in the RESPECT trial). Therefore, a major limitation of this study is that these conclusions cannot be generalized to elderly patients (over the age of 65).  The effect sizes, although not statistically significant, favor closure, suggesting that the studies might have been underpowered to detect a true difference. Future analyses are required to study long-term outcomes and further inform the debate over PFO management.

Click here to read about the PC trial in NEJM

Click to read about the RESPECT trial in NEJM

Click to read an accompanying editorial in NEJM

By Jonathan Liu and Mitalee Patil

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