PARTNER IIA 2-Year Intermediate-Risk Data Presented for Edwards Sapien XT TAVR Device

April 2, 2016—Two-year results from the PARTNER IIA trial of Edwards Sapien XT transcatheter aortic valve replacement (TAVR) device were presented by Craig Smith, MD, in a late-breaking trial session at the American College of Cardiology’s (ACC) 65th annual scientific session, held April 2–4 in Chicago, Illinois. The study was simultaneously published online in The New England Journal of Medicine.

According to ACC, the data from this noninferiority trial demonstrated that intermediate-risk patients with severe aortic stenosis receiving TAVR had similar rates of death and disabling strokes after 2 years compared with those patients undergoing surgical aortic valve replacement. Patients receiving TAVR also experienced shorter hospital stays and lower incidence of some major complications compared with those undergoing surgery. 

The data suggest that TAVR is at least as safe and effective as surgery in these intermediate-risk patients. Overall, the primary endpoint of all-cause death and disabling strokes was comparable at 2 years (19.3% for TAVR and 21.1% for surgery). Among TAVR patients with transfemoral placement of the valve, the combined rate of death and disabling stroke was lower (16.8% for TAVR and 20.4% for surgery; P = .05).

The randomized controlled PARTNER IIA trial was composed of 2,032 intermediate-risk patients treated between December 2011 and November 2013 at 57 sites, all but two in the United States. Patients were randomly assigned to TAVR (n = 1,011) and to surgery (n = 1,021). Of those patients in the TAVR group, 76% underwent transfemoral placement, and the others had transthoracic placement. The heart team discussed each individual case to determine if patients were indeed at intermediate risk. Baseline characteristics were comparable. All patients were followed for at least 2 years and will continue to be followed for 5 years. 

Martin. B. Leon, MD, who is Coprincipal Investigator of the PARTNER trials, commented in the ACC announcement, “For the past 5 years, TAVR has been growing in use and acceptance largely based upon clinical evidence from multiple randomized controlled trials, but these have been limited to patients at the highest risk for surgery. Here, we demonstrate outcomes related to death and stroke, which are equivalent in these patients and may be superior in the transfemoral group.” Dr. Leon is professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center-New York Presbyterian Hospital in New York, New York.

He added, “When we compare transthoracic TAVR patients to those having surgery, they are about the same, so whatever benefit achieved related to lower rates of death and strokes was clearly in the transfemoral group.” 

The PARTNER IIA investigators also reported significant differences in secondary clinical endpoints looking at time in the hospital, valve function, and major complications, some favoring TAVR, some surgery. TAVR patients spent less time in the hospital overall; the average time in the intensive care unit was 2 days with TAVR versus 4 days with surgery, and the average hospitalization for TAVR was 6 days compared to 9 days with surgery. TAVR also appeared to improve the aortic valve areas more than surgery as measured by echocardiography during follow-up points through 2 years. 

Compared to surgery, TAVR yielded significantly lower rates of acute kidney injury, severe bleeding events, and new onset atrial fibrillation. The surgery group had fewer major vascular complications and fewer incidents of paravalvular regurgitation. 

“The 2-year follow-up allows enough time to accurately assess the relative performance of these two valve replacement therapies,” stated Dr. Leon, adding that he suspects these findings will potentially affect clinical guidelines for TAVR in the future. “We know surgery is good, but it is still a major procedure and for many patients, a less-invasive approach may be the preferred alternative. As we continue to evolve the procedure and technology, it’s important to know whether TAVR is an effective alternative in these lower risk patients.” 

Also at ACC.16, Vinod Thourani, MD, is presenting findings comparing Edwards’ next-generation Sapien 3 TAVR device to surgery. Dr. Thourani is Professor of Surgery and Medicine and Chief of Cardiothoracic Surgery at Emory Hospital Midtown and Co-Director of the Structural Heart and Valve Center at Emory University School of Medicine in Atlanta, Georgia.