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PFO closure bested medical management alone for reduction of ischemic stroke

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Patients with a history of cryptogenic stroke had better outcomes with patent foramen ovale closure as compared with medical management alone, according to data from the RESPECT PFO trial.

Results from the overall trial, presented previously, demonstrated that PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical) reduced the frequency of recurrent ischemic strokes, in comparison with medical management alone consisting of antiplatelet medication or warfarin. The trial included 980 patients (mean age, 46 years). Researchers performed detailed patient screening to exclude cardioembolism, large artery arteriopathy, small artery disease and other non–PFO-related stroke causes.At the International Stroke Conference 2013, Jeffrey L. Saver, MD, director of the stroke and vascular neurology clinics at Geffen School of Medicine, University of California, Los Angeles, and colleagues presented data on qualifying and outcome ischemic strokes in the RESPECT PFO trial. All 25 primary endpoint events were recurrent ischemic strokes; 16 in the medical management group and nine in the device group. In the device group, three ischemic strokes occurred without a device in place and three occurred in a deep penetrator artery distribution, according to the study abstract.

 

Jeffrey L. Saver

According to time-to-event analyses, there was a trend for benefit associated with device therapy in the intention-to-treat population (HR=0.5; 95% CI, 0.22-1.13). There was significant benefit in the per-protocol (HR=0.37; 95% CI, 0.14-0.97) and as-treated (HR=0.28; 95% CI, 0.1-0.76) populations.

The middle cerebral artery was the most commonly involved vascular territory, in 54% of the medical management group and 57% of the device group.

“The event types particularly averted in the device group were those associated with paradoxical embolic stroke mechanism: infarcts of larger size and infarcts with a superficial or multiple penetrating artery topography,” Saver said.

For more information:

Saver JL. LB3. Presented at: International Stroke Conference 2013; Feb. 5-8, 2013; Honolulu.

Disclosure: Saver reports receiving funding and consulting from Covidien.