The Placement of Aortic Transcatheter Valve (PARTNER) Trial

Trial is a very well-designed, meticulously executed, prospective randomized trial that demonstrated that transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve was superior to medical therapy in the treatment of inoperable patients with aortic stenosis (cohort B) and that it was not inferior to standard surgical aortic valve replacement in patients with advanced symptomatic aortic stenosis who are high risk for surgical therapy (cohort A). Every patient enrolled in the trial was discussed by conference call before enrollment was accepted. Enrolling sites were centers of excellence in surgical valve replacement and in interventional cardiology. The trial demonstrated a 20% survival advantage in the nonoperable cohort A patients at 1 year. This level of benefit is rare in medical device therapy. In the high-risk surgical patients, TAVR and surgical valve replacement each demonstrated equivalent 1-year mortality (TAVR, 24.2%; surgical aortic valve replacement, 26.8%) and equivalent 1-year relief of symptoms. The results of the trial led to approval by the Food and Drug Administration of the device for commercial use in inoperable patients. Use of the device in the United States for high-risk surgical patients is under consideration. This therapy is of great benefit to patients who are similar to those enrolled in the trial. Certainly, this is cause for celebration.