Methods

The design and conduct of the trial have been previously described in detail. In brief, female patients with New York Heart Association (NYHA) class II or greater symptoms and severe aortic stenosis, defined as an aortic valve area ≤0.8 cm ² or aortic valve index ≤0.5 cm ² /m ² and either a mean aortic valve gradient >40 mm Hg or a peak aortic valve velocity >4.0 m/s, at rest or with a dobutamine stress test if the left ventricular ejection fraction was <50%, were eligible for randomization in the clinical trial. Patients were considered high risk if 2 cardiac surgeons and 1 interventional cardiologist at the clinical site estimated a 15% or greater risk of mortality at 30 days in the absence of extreme risk. Patient selection has been previously described in detail. Valve-related or preidentified events were adjudicated by an independent clinical events committee using standardized Valve Academic Research Consortium I criteria. Echocardiograms were evaluated by an independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota). Valvular regurgitation was determined using Valve Academic Research Consortium I criteria.

Categorical variables were compared with the use of the chi-square or Fisher exact test. Continuous variables are presented as mean ± SD and compared with the use of the Student t test for independent samples and the use of a paired t test for matched samples. Kaplan–Meier event estimates were used to construct the survival curves based on all available follow-up for the time-to-event analysis. The log-rank test was used to compare the time to events. All testing used a 2-sided alpha level of 0.05. All statistical analyses were performed with the use of SAS software, version 9.2 (SAS Institute, Cary, North Carolina).

Results

Women represented 353 of the 747 patients (47.3%) who underwent attempted treatment in the high-risk clinical trial. The as-treated TAVR cohort comprised 183 women of 390 total patients (46.9%), and the as-treated SAVR cohort comprised 170 women of 357 total patients (47.6%). Baseline characteristics in the cohort were well matched ( Table 1 ) with the only difference seen in diabetic status, where there were more women with diabetes in the surgical cohort than the TAVR cohort. Risk factors and frailty measurements ( Table 2 ) were also similar. As reported in Table 3 , baseline effective orifice area (EOA) and mean gradient were well matched between TAVR and SAVR (0.68 ± 0.20 vs 0.68 ± 0.24 cm ² , p = 0.77, and 51.16 ± 16.15 vs 50.82 ± 14.85 mm Hg, p = 0.84, respectively). Baseline left ventricular ejection fraction was also well matched between TAVR and SAVR (61.02% ± 10.30% vs 60.21% ± 10.24%, p = 0.46).

Clinical outcomes and echocardiographic results were collected for a mean 407.1 ± 195.6 days. As reported in Table 4 , at 30 days, there was no difference in cardiovascular (3.8% vs 4.7%; p = 0.70) or all-cause (3.8% vs 4.7%; p = 0.70) mortality in women undergoing TAVR or SAVR. Other clinical outcomes in women, including stroke (5.6% vs 6.5%; p = 0.73) and myocardial infarction (1.6% vs 0.6%; p = 0.35), were not different. However, there was a higher risk in TAVR of major vascular complications (7.7% vs 0.6%; p = 0.001), cardiac perforation (2.7% vs 0.0%; p = 0.03), and permanent pacemaker implantation (20.7% vs 7.2%; p <0.001). TAVR appeared to be protective for acute kidney injury (2.8% vs 17.6%; p <0.001).

At 1 year, women who underwent attempted treatment with TAVR had significantly lower all-cause mortality compared with those who underwent SAVR ( Figure 1 , 12.7% vs 21.8%; p = 0.03). Despite lower noncardiovascular mortality (3.6% vs 8.9%; p = 0.05; Table 4 ), there was no difference in cardiovascular (9.4% vs 14.2%; p = 0.19, Figure 1 ) or valve-related mortality (4.5% vs 2.7%; p = 0.33, Table 4 ). The composite end point of all-cause mortality or major stroke at 1 year ( Figure 1 ) was significantly lower in women undergoing TAVR (14.9% vs 24.2%, 0.04). When 1-year mortality, stroke, acute kidney injury, and major vascular complications outcomes were adjusted for baseline diabetes status (the only baseline characteristic different between the cohorts), this adjustment did not change the overall findings for most outcomes; however, non-cardiovascular mortality trended toward a significant difference before adjustment (hazard ratio 2.54, 0.96 to 6.68, p = 0.06) and was significantly different after adjustment for baseline diabetes (hazard ratio 3.01, 1.14 to 7.97, p = 0.03).

Kaplan–Meier curves depicting all-cause mortality (A) , cardiovascular mortality (B) , and the composite outcome of all-cause mortality or major stroke (C) .

In women, NYHA classification improved over time after both procedures ( Figure 2 ). At baseline, 86.9% of TAVR patients and 79.5% of SAVR patients were in NYHA class III/IV. At 1 year, this was reduced to 4.2% and 3.5%, respectively.

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