Preliminary results showed a significant interaction between treatment effect and access site used for TAVR – transfemoral vs. transapical – and trial outcomes, according to Dr. Cohen, who is director of cardiovascular research at Saint Luke’s Mid-America Heart and Vascular Institute, University of Missouri–Kansas City. Therefore, analyses considered these subgroups separately.
Patients undergoing transfemoral TAVR had better scores on the Kansas City Cardiomyopathy Questionnaire at 1 month than their surgical counterparts (difference, 9.9 points; P less than .001). But there was no longer a significant difference at 6 or 12 months.
Patients undergoing transapical TAVR had worse scores than their surgical counterparts at 6 months (difference, 7.9 points; P = .04). But there was no significant difference at 1 or 12 months.
The findings were much the same for the individual subscales of the Kansas City Cardiomyopathy Questionnaire, and for additional, generic measures of health and quality of life assessed in the trial (the Short Form-12 Health Survey and the EQ-5D questionnaire), according to Dr. Cohen.
Furthermore, the findings held up in sensitivity analyses that were restricted to only patients who actually had attempted valve replacement, that used worst-case values for patients with missing data, and that instead categorized outcomes dichotomously.
The trial was sponsored by Edwards Lifesciences. Dr. Cohen reported that he receives research or grant support from Abbott Vascular, Boston Scientific, Medtronic, AstraZeneca, and Edwards Lifesciences; and is a consultant to, is a speaker for, or receives honoraria from Daiichi-Sankyo/Eli Lilly and Medtronic. Dr. Mack reported that he had no relevant conflicts of interest.