Late Quality-of-Life Outcomes Are Similar for TAVR and SAVR in PARTNER II Analysis

November 1, 2016—Findings from the PARTNER II QUALITY OF LIFE study were presented at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The study demonstrated that patients with severe aortic stenosis at intermediate surgical risk and who are treated with transcatheter aortic valve replacement (TAVR) had improved health status at 1 month compared with patients treated with surgical aortic valve replacement (SAVR), but 2-year quality-of-life (QoL) outcomes were similar. 

The background of the study is that previous studies have shown that TAVR provides an early QoL benefit in patients with severe aortic stenosis at high surgical risk; however, the effect of TAVR versus SAVR on QoL in intermediate-risk patients was unknown.

As summarized in the TCT announcement, 2,032 intermediate-risk patients with severe aortic stenosis were randomized to TAVR (n = 1,011) with the Sapien XT device (Edwards Lifesciences) or SAVR (n = 1,021) in the PARTNER II trial between 2011 and 2013. QoL was assessed for all patients at baseline, as well as at 1, 12, and 24 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36, and EQ-5D.

The study found that at 2-year follow-up, both TAVR and SAVR were associated with clinically and statistically significant improvements in disease-specific and generic QoL measures compared with baseline. 

The 2-year change in KCCQ Overall Summary Score was 19.2 points with TAVR compared with 18.3 points for SAVR. Similarly, the 2-year change in the SF-36 Physical Component Summary Score was 3 points with TAVR versus 2.7 points with SAVR. In contrast, at 1 month, TAVR was associated with significantly better QoL than SAVR, but this difference was restricted to patients who were treated via transfemoral access and was not seen in patients who were treated via alternative (transapical or transaortic) access (P < .01 for interaction). There were no significant differences between TAVR and SAVR in any QoL measure at 1 or 2 years.

The study’s Lead Investigator David J. Cohen, MD, commented in the TCT announcement, “This study shows that among intermediate-risk patients with severe aortic stenosis, QoL improved significantly and to a similar extent with TAVR and SAVR through 2 years. However, transfemoral (but not transthoracic) TAVR was associated with a substantial and clinically important early health status benefit compared with SAVR.” 

Dr. Cohen added, “We believe that these early differences in QoL may be important to many patients who are suitable candidates for both procedures. Longer-term follow-up is needed to assess the durability of QoL improvement with TAVR versus SAVR in this intermediate-risk population.”