Two recent editorials discuss the somewhat unsatisfying results from the RESPECT trial. The study enrolled patients with cryptogenic stroke and a PFO to optimal medical therapy or to PFO closure with the Amplatzer PFO occluder device. Discussion points include patient selection, endpoints, efficacy and P-values.
The RESPECT Trial: What Will the FDA Do?
by Ziyad M. Hijazi, MD, MPH
One of the many shortcomings of comparative observational studies examining patent foramen ovale (PFO) closure versus medical management included in meta-analysis is failure to adjust for potential confounders; therefore, the need for randomized studies is very obvious since they provide the best scientific evidence……..
A Respectable Result? Or Do We Need More Closure?
by Steven L. Goldberg, MD
I was reminded of this image of hell when I listened to the results of the RESPECT randomized trial. It is full of some compelling data regarding benefit of PFO closure to prevent recurrent stroke, but because the primary endpoint had a P-value of 0.08, I am anxious that we will not be able to make use of that delicious data……