Results from the RESPECT trial suggest that closure with the AMPLATZER Patent Foramen Ovale (PFO) Occluder over medical management alone may reduce stroke risks in carefully selected patients with history of cryptogenic stroke and PFO.

The multi-center study, which was presented on Oct. 25 as part of TCT 2012, was based on 980 patients with PFO in the U.S. and Canada who had a cryptogenic stroke within 270 days. Data showed the primary endpoint (all recurrent strokes) was similar between the PFO closure and medical therapy arms (1.8 vs. 3.3 percent, relative risk [RR] 0.53, 95 percent confidence interval [CI] 0.23-1.22, p = 0.16). Results were similar on analyzing using time-to-event analysis given the unequal dropout rates (HR 0.49, 95 percent CI 0.22-1.11, p = 0.08). On per-protocol analysis, there was a benefit favoring PFO closure (HR 0.37, 95 percent CI 0.14-0.96, p = 0.03). On subgroup analysis, there were trends toward a benefit in patients with large shunts (p = 0.07), atrial septal aneurysms (p = 0.10), and those on concomitant antiplatelet medications (p = 0.19). The study investigators noted that the primary analysis using the raw count of the "Intend to Treat" cohort was deemed invalid because the exposure to the two treatment options was unequal due to a greater drop-out rate in the medical group.

The investigators also observed stroke risk reduction across the totality of analyses with rates ranging from 46.6 percent to 72.7 percent. In addition, they noted that "closure with the AMPLATZER PFO Occluder exposes patients to a very low risk of device- or procedure-related complications."

Additional Resources Clinical Trial Summary  Download the Presentation Slides

Looking ahead, the presenters stressed that the results could have "substantial import for the treatment of patients with a history of cryptogenic stroke and PFO." They noted that patient follow-up is on-going and will continue to provide "additional longer-term information regarding benefits, risks, and differential treatment effects in sub-populations."

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