Table 4

Demographic and Other Baseline Characteristics of the PARTNER Trial (Cohort B Data First)

CharacteristicCohort BCohort A
TAVR (N=179)Standard Rx (N=179)p ValueTAVR (N=348)AVR (N=351)p Value
Demographics
Age (y)83.1 ± 8.683.2 ± 8.30.9583.6 ± 6.884.5 ± 6.40.07
Male (%)45.846.90.9257.856.70.82
STS score11.2 ± 5.811.9 ± 4.80.2111.8 ± 3.311.7 ± 3.50.61
Logistic EuroSCORE26.4 ± 17.230.4 ± 19.10.0429.3 ± 16.529.2 ± 15.60.93
NYHA functional class III or IV (%)92.293.90.6894.394.00.79
O2-dependent COPD (%)21.225.70.389.27.10.34
Frailty (%)18.1280.0915.617.60.58
Porcelain aorta (%)1911.20.050.61.10.69
Chest wall radiation (%)8.98.41.000.90.91.00
Chest wall deformity (%)8.45.00.2900.31.00
Echocardiographic Characteristics
AV area (cm2)0.6 ± 0.20.6 ± 0.20.970.7 ± 0.20.6 ± 0.20.13
Mean AV gradient (mm Hg)44.5 ± 15.743.0 ± 15.30.3942.7 ± 14.643.5 ± 14.30.45
Mean LV EF (%)53.9 ± 13.151.1 ± 14.30.0652.5 ± 13.553.3 ± 12.80.45

Data are derived from the Edwards Lifesciences' briefing document for the U.S. FDA Circulatory Devices Advisory Panel meeting on TAVR on July 21, 2011 (http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041b.pdf) and may show some discrepancies compared with the published manuscripts.

Cohort B includes only nonsurgical candidates in whom “inoperability” was formally defined as greater than 50% predicted probability of mortality or serious irreversible complication by 30 days by 1 cardiologist and 2 cardiothoracic surgeons.

Cohort A includes patients determined to be at high operative risk defined as predicted operative mortality of ≥15% and/or an STS risk score of ≤10%. The STS risk algorithm is based on the presence of coexisting illnesses in order to predict 30-day operative mortality.

AV indicates aortic valve; AVR, aortic valve replacement; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; Rx, therapy; STS, Society of Thoracic Surgeons; and TAVR, transcatheter aortic valve replacement.