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.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.