Table 2

Clinical Outcomes

30-Day Clinical OutcomesControl ArmSafety + Device Armp Value
Any MACCE9.9 (11/111)7.3 (17/234)0.40
 Death (all cause)1.8 (2/111)1.3 (3/234)0.65
 Stroke9.1 (10/110)5.6 (13/231)0.25
 Disabling0.9 (1/109)0.9 (2/231)1.00
 Nondisabling8.2 (9/110)4.8 (11/231)0.22
 AKI (stage 3)0.00.4 (1/231)1.00
TIA0.00.4 (1/231)1.00
Major vascular complication5.9 (7/119)8.6 (21/244)0.53
 Radial/brachialNA0.4 (1/244)
 Femoral5.9 (119)8.2 (20/244)

Values are % (n/N).

AKI = acute kidney injury; MACCE = major adverse cardiac and cerebrovascular events; other abbreviations as in Table 1.

  • MACCE defined as death (any cause), stroke (any), AKI (stage 3).