Sex-Specific Differences for Outcomes in TAVR
What are the sex-specific differences in patients undergoing transcatheter aortic valve replacement (TAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial?
This was a secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. Twenty-five hospitals in the United States, Canada, and Germany participated in the study. High-risk and inoperable patients (1,220 women and 1,339 men) were enrolled and underwent TAVR. Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters were measured. To assess the association between sex and all-cause mortality at 1 year, Cox multivariable regression analyses were performed.
At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease, but higher Society of Thoracic Surgeons (STS) Predicted Risk of Mortality scores (11.9% vs. 11.1%; p < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points; 95% confidence interval [CI], 4.63-9.95 percentage points; p < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points; 95% CI, 0.57-5.04 percentage points; p = 0.012), but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, −8.3 percentage points; 95% CI, −11.7 to −5.0 percentage points; p < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point; 95% CI, −1.29 to 2.45 percentage points; p = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point; 95% CI, −0.62 to 2.19 percentage points; p = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72; 95% CI, 0.61-0.85; p < 0.001).
The authors concluded that despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year.
The principal finding of this analysis was that women undergoing TAVR had a lower mortality at 1 year despite having higher 30-day incidence of vascular complications and major bleeding. Unadjusted and adjusted results showed that female sex was independently associated with lower 1-year mortality. This is in contrast to aortic valve surgery, in which female sex has been shown to be an established risk factor for adverse prognosis after surgical AVR, and is reflected in the STS risk model of aortic valve surgery. Furthermore, with newer devices requiring smaller sheath sizes for implantation, the incidence of vascular complications will probably decrease, making this modality even more attractive for appropriately selected women needing AVR.
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