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Closure may benefit patients with high-risk PFO
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ORLANDO, Fla. — Among patients with recent cryptogenic stroke likely due to a patent foramen ovale deemed by echocardiography as high risk, PFO closure plus medical therapy conferred better outcomes than medical therapy alone, according to the results of the DEFENSE-PFO study.
“We sought to determine whether the benefit from device closure of a PFO can be determined on the basis of the morphologic characteristics of the PFO,” Jae Kwan Song, MD, a cardiologist at Asan Medical Center in Seoul, South Korea, said during a presentation at the American College of Cardiology Scientific Session.
Song and colleagues defined a high-risk PFO as at least 2 mm in diameter as determined by transesophageal echocardiography, atrial septal aneurysm or hypermobility, defined as septal excursion of at least 10 mm.
They assigned 120 patients (mean age, 52 years; 56% men) to standard medical treatment alone or standard medical treatment plus PFO closure with a device (Amplatzer PFO Occluder, Abbott/St. Jude Medical). The trial was terminated early in fall 2017 when three studies were published linking PFO closure to reduced risk for recurrent stroke in this population.
The primary endpoint was a composite of stroke, vascular death or TIMI major bleeding. Median follow-up was 2.8 years.
Of the 60 patients assigned PFO closure, seven declined to undergo the procedure, Song said, noting that the other 53 patients had their PFO successfully closed without fatal complications. Four patients from the medication group ended up having their PFO closed, he said.
The medication-only group was assigned warfarin, single antiplatelet therapy or dual antiplatelet therapy at the discretion of the local investigator, whereas the closure group was advised to take DAPT for at least 6 months, which could be modified by the attending neurologist, Song said.
Two patients in the closure group had nonfatal procedural complications: one had pericardial effusion and one had pseudoaneurysm, both of which led to atrial fibrillation, according to the researchers.
During the study period, the primary endpoint occurred in no patients from the closure group but in six patients from the medication group (2-year event rate, 0% vs. 12.9%; log-rank P = .013), Song said.
Five of the six patients from the medication group who achieved the primary endpoint had an ischemic stroke (2-year event rate, 0% vs. 10.5%; log-rank P = .023), he said.
The primary endpoint did not occur in any of the patients who changed treatment arms, so the as-treated and per-protocol analyses were similar for the primary endpoint, according to the researchers.
“The benefit of closing a PFO for secondary prevention in patients with cryptogenic stroke can be determined on the morphologic characteristics of the PFO and the adjacent interarterial septum,” Song said during the presentation.
The study was simultaneously published in the Journal of the American College of Cardiology. – by Erik Swain
References:
Song JK, et al. Late-Breaking Clinical Trials V: Interventional. Presented at: American College of Cardiology Scientific Session; March 10-12, 2018; Orlando, Fla.
Lee PH, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.02.046.
Disclosures: The authors report no relevant financial disclosures.
Perspective
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Gregg W. Stone, MD
This was small study that was underpowered and prematurely terminated. There was a high rate of crossover in both arms, but fortunately, the study was still positive. Unfortunately, we can’t draw any conclusions about the utility of using high-risk vs. low-risk PFO morphologic criteria from this study because there was not a randomized arm of low-morphologic-risk PFO. Maybe the investigators would have found that PFO closure wouldn’t have been beneficial in cases of low-risk PFO, but perhaps the same relative risk reduction would have been seen. I tend to believe Dr. Song’s conclusions, but this study does not support a morphologic-based decision-making process to determine which PFOs to close.
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Dipti Itchhaporia, MD, FACC
I’d like to congratulate Dr. Song and colleagues for taking on the issue of closing a PFO after cryptogenic stroke. There has been some controversial data out there, so tackling this was important. The study suggests that benefits of PFO closure may be determined based on morphologic characteristics of the PFO. That point was initially illustrated by the CLOSE study and is now reinforced by this study.
An interesting point is that while standard medical therapy was supposed to be prescribed, only 25% of patients were on anticoagulants. This suggests some variation in the definition of standard medical therapy. There needs to be more work done to define optimal medical therapy for these patients, probably in a larger study. However, in my mind, this study made it clear that we do have to look at the morphologic characteristics before we do a PFO closure to help confirm our instincts about who would benefit.
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