VDM Speaks with John F. Rhodes, MD, U.S. Cardiology Principal Investigator for the REDUCE Trial

Please give us an overview of the REDUCE clinical study.

The REDUCE clinical trial is a study designed to demonstrate that patent foramen ovale (PFO) closure with the GORE^® HELEX Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.

Could you discuss the differences between the REDUCE and CLOSURE I studies in terms of design, patient selection, follow up, primary and secondary outcomes?

There are several differences in the REDUCE and CLOSURE I studies including type of medical management in the device closure arm and medical therapy arm, inherent differences in the two devices and the risk profile of both devices, as well as the requirement of brain magnetic resonance imaging (MRI) and transesophageal echocardiography (TEE) imaging during follow up for the REDUCE patient population.

What do you anticipate the results of the REDUCE study will show?

We anticipate that the study will show that the freedom from recurrent ischemic stroke, imaging-confirmed TIA, or death due to stroke through 24 months post randomization will be superior in the device arm group.

How long will the patients be followed in the REDUCE clinical study? What does the follow-up protocol include?

Randomized subjects will be followed for 60 months with follow-up evaluations at 1, 6, 12, 18, 24, 36, 48 and 60 months. Change in MRI lesions from screening (prior to randomization) through 24 months will be assessed and the device arm subjects will have echocardiographic evaluations of the atrial device.

Is it likely that the FDA will establish an indication for PFO closure to reduce the incidence of recurrent stroke and TIA?

Only if the clinical trials are shown to be superior to standard medical therapy.

Tell us about the GORE HELEX septal occluder device and its applications. What makes this device unique? Will it be a game-changer in the treatment of PFO?

The Gore HELEX Septal Occluder (W.L. Gore & Associates, Inc., Flagstaff, Arizona) is a device made mostly of Gore Tex patch and minimal metal frame. It poses a much lower risk of thrombus formation on the disc, atrial arrhythmia complications from the device, and no reported cases of injury to the heart wall resulting in perforation, a potentially life-threatening complication.

What has been your experience thus far with the GORE HELEX device? T

he device works extremely well for closure of small- and moderate-sized atrial defects and is FDA-approved for this indication. The device has also been shown to work well in PFOs according to reports from Europe as well as in our experience at Duke.

What is the estimated incidence of cryptogenic stroke compared to strokes from identifiable causes?

For patients in the United States How often is PFO the cause of stroke? We do not know the answer to this question, but we do know that 40–60% of cryptogenic stroke patients are found to have a PFO, while the prevalence of PFO in the general population is around 20%.

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Dr. Rhodes is an Associate Professor in Pediatrics and Medicine at Duke University, Chief of the Children's Heart Center, and Director of the Pediatric and Adult Congenital Cardiac Catheterization Laboratory. He is also the National PI for W.L. Gore's REDUCE Trial, a study assessing patients with stroke and PFO.

VASCULAR DISEASE MANAGEMENT 2011;8(2):E50