TAVR matches surgery in intermediate-risk patients

Registries of patients who have undergone transcatheter aortic-valve replacement in Europe and the United States show that this procedure has already been frequently used in selected patients with Society of Thoracic Surgeons operative-risk scores of 4%-8%. Even though regulatory approval specifies using the procedure in high-risk patients with risk scores of at least 8%, the labeling leaves the decision of which patients are at high risk up to local heart teams, and factors other than the risk score play into a patient’s overall risk assessment including frailty and comorbidities.

Despite the prior experience using TAVR in patients with STS risk scores of 4%-8% the results of PARTNER 2A are a game changer because they come from a prospective, randomized, controlled trial.

The PARTNER 2A results are also notable because this is the second randomized trial (in addition to the CoreValve high-risk trial) with results that show or suggest that transcatheter aortic-valve replacement (TAVR) produces better outcomes than surgery, especially in patients who undergo TAVR via a transfemoral approach. Other notable advantages of TAVR over surgery seen in PARTNER 2A include substantial reductions in disabling or life-threatening bleeding events and in new-onset atrial fibrillation, a statistically significant reduction in acute kidney injury, and no significant difference in the incidence of disabling strokes. In the past, we expected stroke rates to be higher with TAVR, but in PARTNER 2A, with neurologists adjudicating the strokes, we saw no difference in the TAVR and surgical stroke rates, a finding that was probably unexpected for many people.

Dr. Ajay J. Kirtane

The patients enrolled in PARTNER 2A were clearly at lower risk for all-cause mortality than the patients enrolled in the earlier TAVR trials. The operative risk score is just one of several ways to estimate patient risk. The data collected in PARTNER 2A provide a robust resource for finding new, additional ways to assess patients who are at intermediate risk and to match patients seen during routine practice to those who entered this trial.

Dr. Ajay J. Kirtane is an interventional cardiologist and director of the coronary catheterization laboratory at New York–Presbyterian/Columbia University in New York. He was a coinvestigator on prior Sapien TAVR studies but did not participate in PARTNER 2. His institution has received research support from Edwards and from Boston Scientific. He made these comments in an interview.