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RESPECT, PC trials examine outcomes with PFO closure device

Issue: December 2012

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MIAMI — Using an investigational patent foramen ovale closure device was superior to medical management alone for the prevention of recurrent stroke, according to data from the RESPECT trial.

The prospective, randomized, multicenter RESPECT trial was designed to evaluate outcomes with the Amplatzer PFO Occluder (St. Jude Medical) as compared with current standard medical treatment in the prevention of recurrent stroke. Made of wire mesh, the device is inserted into the PFO through a catheter to seal the passageway between the left and right aorta, according to a press release.

John D. Carroll, MD, presented data on 980 patients (mean age, 46 years) diagnosed with a cryptogenic stroke enrolled during 8 years. The patients were randomly assigned to the Amplatzer PFO Occluder or medical management within 270 days of experiencing the stroke.

According to results, 2-year event rates were low in both the device and medical management groups (1.6% vs. 3%).

Depending on the analysis population assessed, the clinical risk reduction of stroke using the device ranged from 46.6% to 72.7% compared with medical management alone. This was borderline significant in the intent-to-treat analysis population and significant in the per-protocol and as-treated analyses.

Serious adverse events were similar between the device and medical management groups (23% vs. 21.6%). The total incidence of atrial fibrillation was not statistically different between the device and medical management groups (3% vs. 1.5%). The researchers observed no device-related thrombus, erosion, embolization or study-related deaths.

“The optimal secondary prevention strategy following a cryptogenic ischemic stroke in patients who are found to have a PFO has been unknown. This need to know is particularly intense for young stroke patients who have no or minimal traditional risk factors for ischemic stroke, yet face a risk of recurrent stroke for many decades.

“RESPECT makes progress in both removing the ‘unknown’ or cryptogenic cause of some strokes and providing high quality data from a large, long-term randomized trial,” Carroll, professor of medicine, co-director of the Cardiac and Vascular Center and director of interventional cardiology at University of Colorado, stated in a press release.

In this study, medical management included one of four regimens: warfarin (25.2%); clopidogrel (14%); aspirin (46.5%); or aspirin plus dipyridamole (8.1%).

Stephan Windecker, MD, professor and head of interventional cardiology at the Swiss Cardiovascular Center in Bern, presented results of the PC Trial during a late-breaking clinical trials session.

The trial compared the efficacy of the Amplatzer PFO Occluder with medical management in 414 patients with cryptogenic stroke with peripheral embolism. Patients were randomized at 29 centers in Europe, Brazil, Canada and Australia. Enrollment was completed in February 2009.

Windecker reported a relative risk reduction of 37% (HR=0.63; 95% CI, 0.24-1.62) for the primary endpoint of death from any cause, nonfatal stroke, transient ischemic attack and peripheral embolism. Results also indicated no significant reduction in ischemic and bleeding events in patients who underwent PFO closure compared with those who received medical therapy (2.9% vs. 5.7%; HR=0.49; 95% CI, 0.19-1.32). The relative risk reduction of stroke with the device was 80% (P=.14), with a number needed to treat of 40, according to a press release.

“The observed difference in stroke may be clinically relevant if confirmed in further studies,” Windecker said during his presentation.

For more information:

Carroll JD. Plenary session XVI. Late breaking trials II.

Windecker S. Plenary session XVI. Late breaking trials II. Both presented at: TCT 2012; Oct. 22-26, 2012; Miami.

Disclosure: Carroll reports grant/research support and consultant fees from AGA Medical Corporation/St. Jude Medical. Windecker reports grant/research support and equity from Abbott Vascular, Biosensors, Biotronik, Boston Scientific, Cordis, Medtronic, CardioVascular and St. Jude Medical.