Article Figures & Data
- Figure 1
Design and flow of the Clinical Registration Trial of Intracranial Stenting for Patients with Symptomatic Intracranial Artery Stenosis Study. BMS, balloon-mounted stent; mRS, modified Rankin Scale; SES, self-expanding stent.
- Table 1
Baseline characteristics and 30-day safety outcomes
Characteristics Patients
(n=1140)Therapy BMS
(n=375)SES
(n=714)Angioplasty
(n=51)P value* Age, mean (SD) 62.4 (9.2) 68.1 (6.3) 59.0 (8.9) 66.6 (9.5) <0.0001 Sex (male) 833 (73.1) 274 (73.1) 520 (72.8) 39 (76.5) 0.8518 Hypertension 878 (77.0) 313 (83.5) 525 (73.5) 40 (78.4) 0.0010 Diabetes mellitus 242 (21.2) 73 (19.5) 154 (21.6) 15 (29.4) 0.2481 Hyperlipidemia 367 (32.2) 122 (32.5) 228 (31.9) 17 (33.3) 0.9644 Smoking 550 (48.3) 167 (44.5) 346 (48.5) 37 (72.6) 0.0008 Coronary heart disease 225 (19.7) 103 (27.5) 115 (16.1) 7 (13.7) <0.0001 Alcohol 68 (6.0) 25 (6.7) 39 (5.5) 4 (7.8) 0.6152 Atrial fibrillation 44 (3.9) 18 (4.8) 22 (3.1) 4 (7.8) 0.1200 Postoperative anticoagulation 85 (7.5) 23 (6.1) 48 (6.7) 14 (27.5) <0.0001 Qualifying artery ICA 195 (17.1) 43 (11.5) 138 (19.3) 14 (27.5) <0.0001 MCA 312 (27.4) 83 (22.1) 208 (29.1) 21 (41.2) VA 352 (30.9) 226 (60.3) 125 (17.5) 1 (2.0) BA 281 (24.7) 23 (6.1) 243 (34.0) 15 (29.4) Mori classification A 578 (50.7) 303 (80.8) 239 (33.5) 36 (70.6) <0.0001 B 387 (34.0) 9 (2.52) 366 (50.2) 12 (22.2) C 175 (15.4) 30 (8.4) 143 (19.62) 2 (3.7) Baseline mRS≥3 23 (2.0) 7 (1.9) 16 (2.2) 0 <0.0001 Mean stenosis pre procedure, mean (SD), % 86.3 (5.0) 86.9 (4.7) 85.9 (5.2) 86.4 (4.8) <0.0001 Volume of study centre High 774 (67.9) 313 (83.5) 411 (57.6) 50 (98.0) <0.0001 Middle 294 (25.8) 56 (14.9) 237 (33.2) 1 (2.0) Low 72 (6.3) 6 (1.6) 66 (9.2) 0 Primary outcomes 111 (9.7) 47 (12.5) 62 (8.7) 2 (3.9) 0.0450 Secondary outcomes Ischaemic 53 (4.7) 23 (6.1) 28 (3.9) 2 (3.9) 0.2495 Perforator occlusion 41 (3.6) 17 (4.5) 22 (3.1) 2 (3.9) 0.4696 In-stent thrombosis 8 (0.7) 4 (1.1) 4 (0.6) 0 0.5267 Other 4 (0.4) 2 (0.5) 2 (0.3) 0 0.6753 Haemorrhagic 58 (5.1) 24 (6.4) 34 (4.8) 0 0.1207 SAH 28 (2.5) 15 (4.0) 13 (1.8) 0 0.0446 SICH 30 (2.6) 9 (2.4) 21 (2.9) 0 0.4223 Death 12 (1.1) 5 (1.3) 7 (1.0) 0 0.6499 Data are reported as No. (%) unless otherwise indicated.
*the null hypothesis was that characteristics were not different among three subgroups, the same hereinafter.
BA, Basilar artery; BMS, balloon-mounted stent; ICA, internal carotid artery; MCA, middle cerebral artery; mRS, modified Rankin Scale; SAH, subarachnoid haemorrhage; SES, self-expanding stent; SICH, symptomatic intracranial/intraparenchymal haemorrhage; VA, vertebral artery.
- Table 2
Analyses of 30-day safety endpoints by centre volume
Outcomes Patients (n=1140) Volume of study centre High (n=774) Middle (n=294) Low (n=72) P value Primary outcomes 111 (9.7) 42 (5.4) 62 (21.1) 7 (9.7) <0.0001 Ischaemic 53 (4.7) 21 (2.7) 29 (9.9) 3 (4.2) <0.0001 Perforator occlusion 41 (3.6) 18 (2.6) 21 (7.1) 2 (2.8) 0.0007 In-stent thrombosis 8 (0.7) 3 (0.4) 4 (1.4) 1 (1.4) 0.2567 Haemorrhagic 58 (5.1) 21 (2.7) 33 (11.2) 4 (5.6) <0.0001 SAH 28 (2.5) 12 (1.6) 13 (4.4) 3 (4.2) <0.0001 SICH 30 (2.6) 9 (1.2) 20 (6.8) 1 (1.4) <0.0001 Death 12 (1.1) 3 (0.4) 9 (3.1) 0 0.0004 SAH, subarachnoid haemorrhage; SICH, symptomatic intracranial/intraparenchymal haemorrhage.
- Table 3
Multivariate regression of 30-day safety outcomes
Factors P value OR (95% CI) Care provider-related factors Centre volume Low 0.8456 0.187 (0.056 to 0.627) Middle n/a 1 High <0.0001 0.044 (0.021 to 0.095) Patient-related factors Age <0.0001 1.179 (1.123 to 1.238) Baseline mRS 0.0015 2.619 (1.447 to 4.740) Qualifying artery ICA <0.0001 4.579 (1.539 to 13.625) MCA <0.0001 0.050 (0.016 to 0.158) VA 0.0167 1.453 (0.588 to 3.589) BA n/a 1 Mori classification A <0.0001 0.006 (0.002 to 0.018) B 0.5592 0.095 (0.036 to 0.254) C n/a 1 Therapy-related factors Technique BMS 0.0612 18.214 (7.196 to 46.103) Angioplasty <0.0001 0.591 (0.073 to 4.790) SES n/a 1 The bold values are all <0.05, which is considered as statistically significant.
ICA, internal carotid artery; MCA, middle cerebral artery; mRS, modified Rankin Scale; SES, self-expanding stent; VA, vertebral artery.
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