Sex-Specific TAVR Outcomes Studied in PARTNER II Trial

January 2, 2018—In the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Molly Szerlip, MD, et al published online an analysis of sex-specific outcomes of transcatheter aortic valve replacement (TAVR) with the Sapien 3 device (S3; Edwards Lifesciences) in the PARTNER II S3 high-risk and intermediate-risk cohorts.

According to the investigators, the study's background is that a difference in survival has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for TAVR. However, it is unknown if a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients.

As summarized in JACC: Cardiovascular Interventions, the PARTNER II S3 trial included high-risk (Society of Thoracic Surgeons [STS] risk score > 8% or heart team determination) and intermediate-risk (STS risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the S3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex.

The study was composed of 1,661 patients who were enrolled between October 2013 and December 2014. There were 583 high-risk patients (338 men, 245 women) and 1,078 intermediate-risk patients (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs 13%; P < .001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤ 23-mm valves (74.1% vs 11.1%; P < .001) and were less likely to receive 29-mm valves (1.4% vs 35.1%; P < .001).

The investigators reported that in the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2% vs 1.2%; P = .2) or 1 year (9.3% vs 10.2%; P = .59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs 0.7%; P = .01).

Female sex was associated with increased major vascular complications (7.9% vs 4.4%; P = .003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the high-risk and intermediate-risk cohorts.

The study concluded that there were no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographics of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques advised the investigators in JACC: Cardiovascular Interventions.