Courtesy of Dr. José Álvarez.

This is a multicenter randomized study on patients with patent foramen ovale (PFO) and a first episode of cryptogenic stroke. It only included patients with moderate to large shunt based on the number of bubbles observed in the left atrium within the first three beats after being noticed in the right atrium: an absence of bubbles indicates an absence of shunt; 1 to 5 micro bubbles, a small shunt; 6 to 25 micro bubbles, a moderate shunt; more than 25 micro bubbles, a large or severe shunt.

Patients were assigned 2:1 to foramen closure with Helex Septal Occluder or Cardioform Septal Occluder (Gore & Associates) plus antiplatelet therapy (441 patients)  vs. antiplatelet therapy alone (aspirin or clopidogrel or aspirin plus dipyridamole) (223 patients). Minimum follow up was 2 years and maximum was 5. At 24 months, patients received an MRI and lesions larger than 3 mm on T2 sequence where considered silent ischemic episodes.

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Two primary end points were assessed: one was the incidence of ischemic stroke (recurrent stroke) and the other new brain infarction defined as a composite of ischemic stroke or ischemic brain infarction detected by imaging.

Of all 664 enrolled patients and during a mean follow up of 3.2 years, recurrent stroke was observed in 1.4% patients receiving the device + antiplatelet therapy and in  5.4% of patients receiving antiplatelet therapy alone (HR 0.23;95%CI0.09 to 0.62; p=0.002). The second primary end point (new ischemic brain infarction) was also less frequent in the group receiving the device + antiplatelet therapy (5.7% vs 11.3% RR0.51; 95% CI 0.29 to 0.91; p=0.04), but the incidence of silent brain infarction (only imaging) was similar in both groups (p=0.97). The incidence of adverse effects was similar in both groups. Adverse effects associated to device implantation occurred in 1.4% of patients undergoing the procedure.

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The authors concluded that patients with patent foramen ovale and cryptogenic stroke are at lower risk of recurrent stroke when treated with closure devices plus antiplatelet therapy compared to those undergoing antiplatelet therapy alone.

Editorial Comment

Despite the short follow up, the REDUCE trial shows clinical benefits of patent foramen ovale closure over antiplatelet therapy alone. However, we should bear in mind that 90% of patients in the device group were followed up 24 months, whereas in the medical treatment group only 78% were followed up at 24 months. In addition, 14 patients in the conservative group had PFO closure outside the study scheme.

Courtesy of Dr. José Álvarez.

Original title: Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke (REDUCE Trial).

Reference: N Engl J Med 2017;377:1033-42.

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