Trial finds PFO closure more effective at preventing strokes than medical therapy

RESPECT — From the hallowed vocals of Aretha Franklin’s 1967 rendition to yesterday’s Transcatheter Cardiovascular Therapeutics (TCT) conference in Miami, it’s a word that never ceases to arrest.

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A universal demand for fair regard and treatment, RESPECT now also represents a large scale, randomized clinical trial which found patent foramen ovale (PFO) closure to be potentially superior to medical therapy in preventing recurring strokes.

"In contrast to a previously reported randomized trial for the treatment of cryptogenic stroke, the RESPECT trial enrolled only patients with documented cryptogenic embolic strokes and excluded patients with other potential causes of stroke and/or TIA. The period of follow-up approached nine years and was not restricted to only events within the initial two years of follow-up," said Richard Smalling, MD, PhD, James D. Wood Distinguished Chair in Cardiovascular Medicine at The University of Texas Health Science Center at Houston (UTHealth) in a news release covering the TCT event.

"As a result, the trial enrolled patients at high risk for recurrent events and followed them for a long period of time, enabling the detection of relatively infrequent recurrent stroke," Smalling continued."The totality of evidence in the RESPECT trial clearly demonstrates the superiority of device closure…in patients with the above entry criteria compared to standard medical therapy."

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A total of 980 patients, hailing from 69 sites over the span of eight years (amounting to 2,300 patient years of data), were involved in the trial. Antiplatelet medications or warfarin were utilized as medical regimens within the study; five of the patients in the closure group suffered from an ischemic stroke, whereas 16 in the medically treated group endured the same ordeal.

National Institutes of Health statistics find that approximately one in four people will have PFOs that will not close unless treated, which they seldom are unless there are other heart issues or the patient suffers a stroke as the result of a blood clot. Moreover, PFOs have been held suspect as a possible perpetrator of cryptogenic stroke in those under the age of 55.

"These patients with cryptogenic stroke are typically young and in the height of the productive period of their lives. Preventing a recurrent, potentially devastating, stroke by implanting a small device with very little risk is a huge potential benefit," Smalling said. [See also: ACP joins national effort to prevent heart attacks and strokes]

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