Table 1

Baseline Characteristics and Procedural Details

Control Arm (n = 119)Device Arm (n = 121)Safety Arm (n = 123)Total Randomized (n = 363)p Value
Age, yrs85.0 (78.4–89.4)83.1 (77.2–87.2)82.5 (76.4–87.5)83.4 (78.0–88.2)0.1371
Male51.3 (61/119)47.9 (58/121)44.7 (55/123)47.9 (174/363)0.6062
BMI, kg/m227.0 (23.8–30.5)27.0 (23.7–32.1)26.2 (22.7–30.4)26.7 (23.4–30.8)0.3103
STS PROM Score6.6 (4.5–8.6)5.6 (3.9–8.0)5.8 (3.9–8.0)6.0 (4.2–8.1)0.0860
History of atrial fibrillation30.3 (36/119)34.7 (42/121)30.1 (37/123)31.7 (115/363)0.6932
History of PVD15.1 (18/119)14.0 (17/121)16.3 (20/123)15.2 (55/363)0.9003
History of CAD55.5 (66/119)50.4 (61/121)53.7 (66/123)53.2 (193/363)0.7341
Previous CABG21.0 (25/119)18.2 (22/121)14.6 (18/123)17.9 (65/363)0.4289
Previous PCI16.8 (20/119)17.4 (21/121)15.4 (19/123)16.5 (60/363)0.9367
History of diabetes37.8 (45/119)40.5 (49/121)26.8 (33/123)35.0 (127/363)0.0577
Previous stroke5.0 (6/119)4.1 (5/121)8.1 (10/123)5.8 (21/363)0.4376
Previous TIA6.7 (8/119)7.4 (9/121)8.1 (10/123)7.4 (27/363)0.9678
Heavily calcified aorta2.5 (3/119)1.7 (2/121)3.3 (4/123)2.5 (9/363)0.7791
NYHA functional class III/IV82.8 (96/116)84.9 (101/119)81.7 (98/120)83.1 (295/355)0.8077
Lesion volume as calculated on FLAIR, mm37,916.7 (3,865.4–17,315.3)7,377.5 (2,562.9–19,181.5)N/A7,847.9 (3,243.2–17,854.5)0.4306
Echocardiographic findings
 Valve area, cm20.7 ± 0.20 (118)0.7 ± 0.17 (119)0.7 ± 0.18 (122)0.7 ± 0.18 (359)0.6603
 Mean aortic valve gradient, mm Hg41.0 (33.0–47.0)42.7 (33.6–52.0)41.0 (31.9–49.0)41.0 (33.0–49.0)0.3334
Procedural details
 Sentinel device access0.4918
 RadialNA91.2 (104/112)95.0 (114/119)93.2 (218/231)
 BrachialNA7.0 (8/112)4.2 (5/119)5.6 (13/231)
 Both filters deployedNA92.0 (103/112)96.6 (115/119)94.4 (218/231)0.1570
 At least 1 filter deployedNA99.1 (111/112)100.0 (119/119)99.6 (230/231)0.4848
 Procedure time§68.0 (41.0–96.0)83.5 (54.0–118.0)78.0 (52.0–101.0)74.0 (52.0–106.0)0.0050
 Fluoroscopy time15.0 (9.0–20.0)18.0 (12.0–29.0)14.0 (10.0–27.0)15.0 (10.0–26.0)0.0402
 TAVR device used0.7176
 SAPIEN XT16.9 (20/118)17.5 (21/120)19.0 (23/121)17.8 (64/359)
 SAPIEN 353.4 (63/118)55.8 (67/120)47.9 (58/121)52.4 (188/359)
 CoreValve5.9 (7/118)2.5 (3/120)3.3 (4/121)3.9 (14/359)
 CoreValve Evolut R23.7 (28/118)24.2 (29/120)29.8 (36/121)25.9 (93/359)

Values are median (interquartile range), % (n/N), or mean ± SD (n).

ANOVA = analysis of variance; BMI = body mass index; CABG = coronary artery bypass graft; CAD = coronary artery disease; FLAIR = fluid-attenuated inversion recovery; NA = not applicable; NYHA = New York Heart Association; PCI = percutaneous coronary intervention; PVD = peripheral vascular disease; STS PROM = Society of Thoracic Surgeons predicted risk of operative mortality; TAVR = transcatheter aortic valve replacement; TIA = transient ischemic attack.

  • p values are testing for statistical differences across randomized arms; continuous data are compared using ANOVA for mean, nonparametric ANOVA for median; categorical data are compared using the Fisher exact test.

  • Defined as neurological deficit lasting >24 h confirmed by imaging.

  • The basis is the 2-sided Wilcoxon test.

  • § Defined as time from first vascular access puncture to achievement of hemostasis at the TAVR access site.