SAN FRANCISCO—At two years, in patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery, transcatheter aortic valve implantation remained superior to standard therapy with incremental benefit from one to one years, reducing the rates of all-cause mortality, cardiovascular mortality and repeat hospitalization, based on the PARTNER B data presented Nov. 10, as a late-breaking clinical trial at TCT.11. However, there were more neurologic events in TAVI patients versus standard therapy with five new events between one and two years in TAVI patients.
Cohort B of the PARTNER trial, which included patients with severe aortic stenosis who were not candidates for surgery, randomized 358 patients to transfemoral TAVR with an early generation balloon-expandable bovine pericardial valve or standard therapy (including balloon valvuloplasty) at 21 centers, emphasizing a multi-disciplinary heart team approach.
After two years, the rate of all-cause mortality was 18.2 percent in the TAVI group and 35.1 percent in the standard therapy group. The rate of cardiovascular mortality was 13.2 percent in the TAVR group and 32.1 percent in the standard therapy group.
The rate of repeat hospitalization was 35 percent in the TAVI group and 72.5 percent in the standard therapy group. The rate of stroke at two years was higher–13.8 percent in the TAVI group and 5.5 percent in the standard therapy group.
At two years, in the landmark analysis of patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery, TAVI, compared with with standard therapy, showed marked reduction in the rates of all-cause mortality (18.2 vs. 35.1 percent), cardiovascular mortality (13.2 vs. 32.1 percent) and repeat hospitalization (35 vs. 72.5 percent).
“Some of these patients have died by the two-year point, but not just from their valvular disease, and instead from the comorbidities in this very sick, elderly population,” said study investigator of PARTNER, Raj R. Makkar, MD, director of interventional cardiology and the cardiac cath lab at Cedars-Sinai Medical Center and associate director of the Cedars-Sinai Heart Institute in New York City, during a press conference.
Overall, there were more neurologic events in TAVI patients compared to standard therapy (16.2 vs. 5.5 percent) with five new events (three strokes and two transient ischemia attacks) between one to two years in TAVI patients.
“After 30 days, differences in stroke frequency were largely due to increased hemorrhagic strokes in TAVI patients,” said site principal investigator of PARTNER, Raj R. Makkar, MD, director of interventional cardiology and the cardiac cath lab at Cedars-Sinai Medical Center and associate director of the Cedars-Sinai Heart Institute in New York City.
“The ultimate value of TAVI in ‘inoperable’ patients will depend on careful selection of patients who are not surgical candidates, and yet do not have extreme co-morbidities that overwhelm the benefits of TAVI,” he added.
"Two-year data continue to support the role of TAVR as the standard-of-care for symptomatic patients with aortic stenosis who are not surgical candidates.
Edwards Lifescience is funding both cohorts of the PARTNER trial.
How should physicians convey these complicated results to their patients? As panelist Samir Kapadia, MD, of Cleveland Clinic, explained: If a patient falls within this population and chooses to undergo this procedure, he or she has a 20 percent chance of having a stroke but also has 50 percent chance of dying if he or she does not undergo the procedure.