14
Table 6:
Patient Demographics and Baseline Characteristics –
PIIS3HR VI Population
Characteristic
SAPIEN 3
Valve
Overall
(N= 583)
SAPIEN 3
Valve
Access
(N= 491)
Valve
Non-
Access
New York Heart Association (NYHA) class, no. (%):
Coronary artery disease, no. (%)
Previous myocardial infarction, no. (%)
Previous intervention, no. (%)
Coronary-artery bypass grafting (CABG)
Percutaneous coronary intervention (PCI)
Prior aortic valvuloplasty
Cerebral vascular accident (CVA), no. (%)
Peripheral vascular disease, no. (%)
Chronic obstructive pulmonary disease (COPD),
no. (%):
Atrial fibrillation, no. (%)
Permanent pacemaker, no. (%)
Severe pulmonary hypertension, no. (%)
Chest deformities that preclude an open chest
procedure, no. (%)
Echocardiographic findings
Effective Orifice Area (EOA), cm
2
Mean aortic-valve gradient, mmHg
Mean left ventricular ejection fraction (LVEF), %
Moderate or severe mitral regurgitation, no./total
no. (%)
Safety and Effectiveness Results
Primary Endpoint
The composite rate of all-cause mortality, all stroke, and AI ≥ moderate at 30 days was 6.7% in the
SAPIEN 3 cohort and 15.6% in the SAPIEN cohort, as shown in Table 7. The resulting proportion
difference in the average treatment effect on the treated (ATT; [2]) was -6.9% (90% CI: [-13.3%, -0.5%]).
Since the upper limit of the CI was < 7.5%, the non–inferiority was met.
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