Five-Year PARTNER IIA Data Show Similar Outcomes for TAVR and SAVR in Intermediate-Risk Patients

September 28, 2019—The Cardiovascular Research Foundation (CRF) announced that the 5-year results from the PARTNER IIA trial were presented by Vinod H. Thourani, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.

The trial sought to compare the key 5-year clinical outcomes, bioprosthetic valve function, and quality-of-life measures in patients with severe aortic stenosis (AS) and intermediate surgical risk who were treated with transcatheter aortic valve replacement (TAVR) using the Sapien XT device (Edwards Lifesciences) versus those patients treated with surgical aortic valve replacement (SAVR).

The 2-year primary endpoint from the PARTNER IIA trial was all-cause death or disabling stroke in the intention-to-treat (ITT) population. In April 2016, the 2-year results were presented and demonstrated that TAVR was similar to surgery for the primary endpoint of death or disabling stroke in patients with severe AS and intermediate surgical risk.

As summarized by CFR, the PARTNER IIA investigators randomly assigned 2,032 intermediate-risk patients with severe AS to either TAVR or SAVR at 57 centers. At 5 years, all primary and secondary clinical and echo endpoints were analyzed in both ITT and prespecified as-treated populations. The results showed that the patients treated with TAVR had similar rates of death and disabling stroke compared to those who had SAVR. However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR.

The results presented at TCT 2019 included the following:

• Event rates for the primary endpoint of death or disabling stroke were 47.9% after TAVR and 43.4% after SAVR (hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.95–1.25; P = .21).
• In the transfemoral cohort, there also was no difference at 5 years (44.5% TAVR vs 42% SAVR; HR, 1.02; 95% CI, 0.87–1.2; P = .8).
• In the transthoracic cohort, the rate of death or disabling stroke was significantly higher after TAVR compared to SAVR (59.3% vs 48.3%; HR, 1.32; 95% CI, 1.02–1.71; P = .03).
• Early improvements in functional status and quality of life were maintained through 5 years for both TAVR and SAVR patients.

Dr. Thourani commented in the CRF announcement, “In the longest follow-up for intermediate-risk patients with severe AS, TAVR and SAVR had similar rates of death or disabling stroke. Therefore, TAVR should be considered as an alternative to surgery in intermediate-risk patients with severe aortic stenosis. However, in patients without acceptable transfemoral access, surgery may be the preferred alternative.”