After one month, patients with severe aortic stenosis and intermediate surgical risk had improved health status if they underwent transcatheter aortic valve replacement (TAVR) rather than surgical aortic valve replacement (SAVR), according to an analysis of a randomized study.
The analysis also found that patients in both groups had similar quality of life outcomes at two years.
Lead researcher David A. Cohen, MD, MSc, presented the findings Nov. 1 in a late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C.
Edwards Lifesciences, which manufactures the Sapien XT valve used in the study, funded the trial. Cohen is a consultant to Edwards Lifesciences.
The FDA approved the Sapien XT in June 2014 for inoperable and high-risk patients with severe aortic stenosis. The agency then expanded the approval in October 2015 to include aortic valve-in-valve procedures and in March 2016 to include pulmonic valve replacement procedures.
Cohen said during a news conference that previous studies showed that patients undergoing TAVR had substantial and durable quality of life benefits in extreme risk and inoperable patients compared with SAVR. Those results were only found in early follow-up and in patients treated via a transfemoral approach.
During this trial, known as PARTNER 2A, the researchers randomized 2,032 intermediate risk patients with severe aortic stenosis to SAVR or TAVR with the Sapien XT valve. They measured the quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ), which includes 23 items that measure the following five clinically relevant domains from the patient’s perspective: symptoms, quality of life, self-efficacy, physical limitation and social limitation.
After two years, the KCCQ overall summary score increased 19.2 points in the TAVR group and 18.3 points in the SAVR group. At one month, patients in the TAVR group who were treated via transfemoral access had significant quality of life improvements compared with the SAVR group. However, at one month, patients in the TAVR group who were treated via alternative access (transapical or transaortic) had similar quality of life improvements compared with the SAVR group.
Cohen said that approximately 80 to 90 percent of patients undergo TAVR via transfemoral access.
“Taken together with previous data, these findings demonstrate that for intermediate risk patients suitable for a transfemoral approach, TAVR provides both early and late benefits compared with surgical AVR from the patient’s perspective,” Cohen said during a news conference. “The lack of benefits ineligible for a transfemoral approach suggest that a transthoracic approach may not be preferable to surgical AVR in such patients, at least in the short- and intermediate-term of the study. Further studies will be necessary to determine whether use of other alternative access sites like subclavian, carotid or transcaval can overcome these limitations of the transthoracic approach.”