PARTNER II: Lower-profile Sapien XT valve performs similar to original valve

Issue: May 2013

SAN FRANCISCO — Patients with severe aortic stenosis who were treated with the 18F Sapien XT transcatheter heart valve had similar outcomes when compared with those treated with the original 24F Sapien valve, according to 1-year results of the PARTNER II cohort B trial presented at the American College of Cardiology Scientific Sessions.

Perspective from Gary Mintz, MD

Martin B. Leon, MD, with the Columbia University Medical Center, presented first-time results from the randomized PARTNER II trial, which tested the new Sapien XT 18F valve (Edwards Lifesciences; n=284) against the standard Sapien 24F valve (n=276) in 560 inoperable patients with severe aortic stenosis. Previously, the 24F Sapien valve had been evaluated in the PARTNER trial and the 20% absolute reduction in 1-year mortality of the valve vs. standard therapy led to FDA approval of the device in November 2011.

“However, Sapien was associated with peri-procedural complications, including strokes, vascular events and paravalvular regurgitation,” Leon said during a presentation. “The new lower-profile Sapien XT, currently in general clinical use around the world, incorporates important enhancements to the valve support frame, the valve leaflet geometry and the delivery system, which may be associated with improved clinical outcomes.”

In the present trial, investigators enrolled patients (mean age, 84.4 years; 49.5% women), followed them for a minimum of 1 year, and performed noninferiority and superiority analyses on both intent-to-treat and as-treated cohorts. More than 96% of patients were classified with NYHA HF Class III or IV and 59% were determined to be clinically frail. The primary endpoint was defined as a composite of mortality, stroke and rehospitalization at 1 year.

Data at 30 days revealed that all-cause mortality (Sapien, 5.1% vs. Sapien XT, 3.5%) and disabling stroke (Sapien 3.0% vs. Sapien XT 3.2%) were similar between groups, while major vascular complications were lower in the Sapien XT arm (9.6% vs. 15.5%; P=.04), especially perforations, dissections and hematomas.

The primary endpoint at 1 year did not differ between groups (Sapien XT, 33.9% vs. Sapien, 34.7%; noninferiority P=.0034). Differences in each individual endpoint of all-cause mortality, disabling stroke and rehospitalization did not reach statistical significance.

“This leads us to conclude that Sapien XT represents a worthwhile advance with incremental clinical value and is the preferred balloon-expandable [transcatheter heart valve] system,” Leon said.

Upcoming, the results from PARTNER II cohort A trial will compare the Sapien XT valve with surgery in patients at intermediate risk. – by Brian Ellis

For more information:

Leon MB. Late-breaking clinical trials II: Interventional. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.

Disclosure: Leon reportsthat within the past 12 months he or his spouse has receivedgrant/research support from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic, and being major share stockholder/having equity in Apica, Claret, Sandra and Valve Medical. Edwards Lifesciences sponsored PARTNER II and provided research support to Columbia University for the trial.

Perspective

Gary Mintz, MD

I am not at all surprised by the data because the Sapien XT device is a better and easier device to use, but it is still fundamentally correcting the problem of severe aortic stenosis. If you look at the parallel history of surgical valves, very few change mortality compared with other surgical valves. These are just evolutionary technologies that are easier to use, have better hemodynamics and so on. I think the results in this trial are superb, especially for us in the United States where the rest of the world has this device and it is used clinically, and we have to go through the rigors of FDA-sanctioned trials to get access to something that the rest of the world has.

Gary Mintz, MD

Cardiology Today’s Intervention Editorial Board member

Disclosures: Mintz receives consulting fees/honoraria from Boston Scientific, LightLab, Medtronic and Volcano, and is on the speakers’ bureau for Pfizer.