Table 2.

Target lesion and procedural information

VariableDrug-Coated Balloon, n=141Control, n=144Total, n=285P Valuea
Target lesion location, n/total (%)
 Anastomotic6/139 (4)5/142 (4)11/281 (4)
 Cephalic arch26/139 (19)32/142 (23)58/281 (21)
 Cannulation zone6/139 (4)14/142 (10)20/281 (7)
 Inflow47/139 (34)42/142 (30)89/281 (32)
 Outflow34/139 (24)32/142 (23)66/281 (23)
 Swing point20/139 (14)17/142 (12)37/281 (13)
Tandem lesion (≤2 cm apart), n/total (%)4/141 (3)10/143 (7)14/284 (5)
Vessel, n/total (%)
 Subclavianb1/141 (1)01/285 (0·4)
 Brachial1/141 (1)1/144 (1)2/285 (1)
 Cephalic97/141 (69)97/144 (67)194/285 (68)
 Basilic36/141 (26)41/144 (28)77/285 (27)
 Median cubital2/141 (1)1/144 (1)3/285 (1)
 Other4/141 (3)4/144 (3)8/285 (3)
De novo lesion, n/total (%)43/141 (31)39/144 (27)82/285 (29)0.60
Lesion length, mm, mean±SD28·4±15·129·5±18·728·9±170.77
Balloon fully effaced, n/total (%)0.84
 Yes121/141 (86)126/143 (88)247/284 (87)
 No10/141 (7)8/143 (6)18/284 (6)
 Unable to assess10/141 (7)9/143 (6)19/284 (7)
Reference vessel diameter, mm, mean±SD7.85±27.68±27.77±20.38
 Range, mm2.4–12.04.0–12.02.4–12.0
Nontarget lesion treated, n/total (%)28/141 (20)35/144 (24)63/285 (22)0.39
Preprocedure percentage stenosis (Core Lab),  mean±SD64±964±1064±90.92
 Range, %41–8841.0–8641–88
Adjunctive procedure (e.g., angioplasty,  stent-graft, embolectomy) performed in  the AV access circuit, n/total (%)0.10
 Yes7/141 (5)2/144 (1)9/285 (3)
 No134/141 (95)142/144 (99)276/285 (97)
Any device deficiencies or malfunctions, n/total (%)0.06
 Yes4/141 (3)04/285 (1)
 No137/141 (97)144/144 (100)281/285 (99)
Periprocedural complication, n/total (%)2/141 (1)2/144 (1)4/285 (1)>0.99
Largest predilation balloon diameter, mm, mean±SD8.3±1.88.1±1.88.2±1.80.42
 Range, mm4–125–124–12
Predilation balloon length, mm, mean±SD44±1344±1344±130.99
 Range, mm20–8020–8020–80
Maximum pressure of predilation, atm, mean±SD21±822±822±80.56
 Range, atm8–406–406 40
After predilation stenosis (Core Lab) percentage ±SD22±1022±1122±100.43
 Range, %−2 to 50−9 to 50−9 to 50
No. of study devices, n/total (%)0.001
 1128/141 (91)143/144 (99)271/285 (95)
 213/141 (9)1/144 (1)14/285 (5)
Study balloon diameter, mm, mean±SD8.3±1.88.1±1.88.2±1.80.36
 Range, mm4–125–124–12
Study balloon length, mm, mean±SD51±1246±1249±13<0.001
 Range, mm40–10040–10040–100
Transit time, s, mean±SD18±3219±3919±350.97
 Range, s0–3201–4200–420
Maximum pressure of study balloon, atm, mean±SD9.7±2.112.1±511.0±4.1<0.001
 Range, atm4–143–353–35
Total duration of inflation, s, mean±SD115±3490±41101±40<0.001
 Range, s30–1805–2405–240
Operator able to deliver to intended site, inflate, and retrieve device, n/total (%)151/151 (100)171/171 (100)322/322 (100)NA
Final stenosis (Core Lab) percentage ±SD17±1117±1017±110.70
 Range, %−28 to 47−16 to 44−28 to 47
Adjunctive procedure performed after study device (e.g., angioplasty, embolectomy), patients/no. of procedures2/21/23/40.62
Reason, n/total (%)>0.99
 Residual stenosis 1/2 (50)01/4 (25)
 Other1/2 (50)2/2 (100)3/4 (75)
Treatment, n/total (%)0.33
 Angioplasty2/2 (100)02/4 (50)
 Thrombectomy02/2 (100)2/4 (50)
Procedure success, n/total (%)138/141 (98)143/144 (99)281/285 (99)0.37
Clinical success, n/total (%)140/141 (99)144/144 (100)284/285 (100)0.50
  • All comparisons were exploratory in nature. —, no P value determined; AV, arteriovenous; NA, not applicable.

  • a P value associated with the Wilcoxon rank sum test comparing drug-coated balloon and standard angioplasty groups or the Fisher exact test for categorical data.

  • b Protocol deviation.