Table 1

Baseline Patient and Lesion Characteristics

Control
(n = 34)
Ranger DCB
(n = 71)
p Value
Age, yrs67 ± 968 ± 80.999
Men23 (68)53 (75)0.605
Diabetes mellitus12 (35)28 (39)0.934
Hyperlipidemia requiring medication21 (62)49 (69)0.606
Hypertension requiring medication26 (76)58 (82)0.610
Smoking
 Current17 (50)29 (41)0.022
 Previous7 (21)32 (45)
History of renal insufficiency1 (3)8 (11)0.292
Coronary artery disease13 (38)24 (34)0.821
Calcification
 None5/32 (16)7/70 (10)0.236
 Mild9/32 (28)19/70 (27)
 Moderate11/32 (34)17/70 (24)
 Severe7/32 (22)25/70 (36)
 NA0/32 (0)2/70 (3)
Occlusions11/32 (34)24/70 (34)>0.999
Target lesion length, mm60 ± 4868 ± 460.731
Target lesion location
 Proximal SFA2/32 (6)12/70 (17)0.289
 Mid SFA12/32 (37)31/70 (44)
 Distal SFA17/32 (53)25/70 (36)
 Proximal popliteal1/32 (3)2/70 (3)
TASC II
 A22/32 (69)46/70 (66)0.620
 B7/32 (22)19/70 (27)
 C2/32 (6)5/70 (7)
 D0/32 (0)0/70 (0)
 NA1/32 (3)0/70 (0)
Reference vessel diameter, mm4.5 ± 0.835.0 ± 0.890.039

Values are mean ± SD, n (%), or n/N (%). Modified with permission from Bausback et al. (11).

DCB = drug-coated balloon; NA = not available; SFA = superficial femoral artery; TASC = Trans-Atlantic Inter-Society Consensus Document.

  • Renal failure with serum creatinine >2.0 mg/dl.

  • Calcium grading: none = no calcium on 2 orthogonal views; mild = calcium deposits <180° in circumference and <50% of lesion length; moderate = calcium deposits <180° in circumference and ≥50% of lesion length; severe = deposits ≥180° in circumference and ≥50% of lesion length.