Table 5

Major Outcomes at 30 Days and 1 Year in Cohort B of the PARTNER Trial

Characteristic30 Days1 Year
TAVR (N=179)Standard Rx (N=179)p ValueTAVR (N=179)Standard Rx (N=179)p Value
All-cause death (%)5.02.80.4130.749.7<0.001
All-cause death or rehospitalization (%)11.212.30.7443.670.4<0.001
Event-free MACCE (%)90.594.4NR65.447.10.003
All stroke (%)7.31.70.0211.24.50.03
Major stroke (%)5.61.10.048.43.90.12
All-cause death or major stroke (%)8.43.90.1233.050.30.001
Major vascular complications (%)16.81.1<0.000117.32.2<0.0001
Major bleeding (%)20.63.9<0.000128.414.4<0.001
Pacemaker insertion (%)3.45.00.604.57.80.27
Echocardiographic Endpoints
AV area (EOA) (cm2)1.5 ± 0.40.8 ± 0.2<0.00011.6 ± 0.50.7 ± 0.32<0.0001
Mean AV gradient (mm Hg)11.1 ± 6.633.0 ± 12.5<0.000112.5 ± 10.344.4 ± 15.7<0.0001

Data are based on 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.

AV indicates aortic valve; EOA, effective orifice area; MACCE, major adverse cardiac and cerebrovascular events; NR, not reported; Rx, therapy; and TAVR, transcatheter aortic valve replacement.

  • All-cause death or major stroke was not a predefined endpoint.