Article Figures & Data
Figures
- Figure 1
Study flowchart for patients with carotid artery stenosis at high risk of hyperperfusion. CAS, carotid artery stenting; ITT, intent-to-treat; mRS, modified Rankin Scale; PP, per-protocol; SAP, staged angioplasty.
Tables
- Table 1
Characteristics of patients at baseline
Characteristics Overall
(n=64)Treatment P value SAP
(n=33)Regular CAS
(n=31)Age, year, median (IQR) 66±7.4 65±7.1 67±1.6 0.32 Female, n (%) 12 (18.8) 7 (21.2) 5 (16.1) 0.60 Risk factors, n (%) Hypertension 48 (75.0) 23 (69.7) 25 (80.6) 0.31 Diabetes 23 (35.9) 15 (45.5) 8 (25.8) 0.10 Dyslipidaemia 27 (42.2) 13 (39.4) 14 (45.2) 0.64 Previous ischaemic stroke 19 (29.7) 9 (27.3) 10 (32.3) 0.66 Coronary heart disease 12 (18.8) 6 (18.2) 6 (19.4) 0.90 Current or previous smoking 35 (54.7) 15 (45.4) 20 (64.5) 0.12 Moderate to heavy alcohol 24 (37.5) 11 (33.3) 13 (41.9) 0.48 Index events, n (%) 0.07 Ischaemic stroke 44 (68.8) 26 (78.8) 18 (58.1) TIA 20 (31.3) 7 (21.2) 13 (41.9) Duration from last symptom to randomisation, day, median (IQR) 17 (5-35) 19 (6–40) 17 (5-34) 0.77 mRS, n (%) 0.35 0 23 (35.9) 9 (27.3) 14 (45.2) 1 25 (39.1) 14 (42.4) 11 (35.5) 2 14 (21.9) 8 (24.2) 6 (19.3) 3 1 (1.6) 1 (3.0) 0 (0.0) 4 1 (1.6) 1 (3.0) 0 (0.0) Systolic pressure, mm Hg, mean±SD 138±21.0 137±20.0 140±22.0 0.65 Mean systolic pressure during the operation, mm Hg, mean±SD 129±12.8 130±14.1 128±11.5 0.51 NIHSS, median (IQR) 0 (0–2) 1 (0–3) 0 (0–1) 0.16 Stenosis degree, %, mean±SD 92.3±4.1 92.4±4.0 91.6±4.2 0.43 Lesion length, mm 15.9±7.6 14.9±8.5 17.0±6.6 0.28 CT perfusion, n (%) 49 (76.6) 27 (81.8) 22 (71.0) 0.31 Concentricity, n (%) 0.43 Concentric 12 (18.8) 8 (24.2) 4 (12.9) Moderately eccentric 29 (45.3) 15 (45.5) 14 (45.2) Extremely eccentric 23 (35.9) 10 (30.3) 13 (41.9) CAS, carotid artery stenting; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SAP, staged angioplasty; TIA, transient ischaemic attack.
- Table 2
Characteristics of patients during perioperative period
Variable SAP (n=26) Regular CAS (n=30) P value First stage Periprocedural BP, mm Hg, mean±SD Preprocedural SBP 141.46±18.33 138.97±22.36 0.74 Preprocedural DBP 80.31±10.66 76.80±11.85 0.32 Postprocedural SBP 130.00±22.09 115.43±20.49 0.01 Postprocedural DBP 73.54±10.01 67.13±14.64 0.15 Max balloon diameter in mm, median (IQR) 3.00 (2.50–3.00) 4.00 (4.00–4.50) <0.01 MLD, %, mean±SD Preprocedure 89.48±17.09 92.32±2.98 0.85 Postprocedure 61.80±19.72 23.42±16.16 <0.01 Preprocedural time of DSA agent from carotid to capillary, mean±SD 4.61±2.19 4.96±1.74 0.26 Postprocedural time of DSA agent from carotid to capillary, mean±SD 3.55±1.51 3.60±1.62 0.78 Second stage Periprocedural BP, mm Hg, mean±SD Preprocedural SBP 136.48±13.78 – – Preprocedural DBP 81.12±10.65 – – Postprocedural SBP 113.35±20.61 – – Postprocedural DBP 67.69±14.69 – – Max balloon diameter in mm, median (IQR) 4.00 (4.00–5.00) – – MLD, %, mean±SD Preprocedure 61.80±19.72 – – Postprocedure 18.11±14.56 – – Preprocedural time of DSA agent from carotid to capillary, mean±SD 3.88±1.66 – – Postprocedural time of DSA agent from carotid to capillary, mean±SD 3.42±1.37 – – BP, blood pressure; DBP, diastolic blood pressure; DSA, digital subtraction angiography; MLD, minimum lumen diameter; SAP, staged angioplasty; SBP, systolic blood pressure.
- Table 3
Characteristics of patients with hyperperfusion syndrome or intracerebral haemorrhage
Variable Case no. 1 2 3 Index event Stroke Stroke Stroke Duration from quality event to randomisation, day 30 47 76 Baseline mRS 2 2 1 Baseline NIHSS 3 4 0 Lesion Characteristics Stenosis degree, % 93.1 90.7 92.0 Length, mm 10.4 19.2 22.5 Concentricity Extremely eccentric Extremely eccentric Extremely eccentric Residual stenosis degree, % 21.3 28.9 22.1 Time of symptom onset 11 hours after the procedure 24 hours after the procedure 12 hours after the procedure Symptoms Headache, confusion, left limb weakness Headache, nausea Headache, right limb weakness HPS or ICH HPS HPS ICH Treatment Strict control of blood pressure, sedation, administration of mannitol mRS at 30 days 4 2 1 HPS, hyperperfusion syndrome; ICH, intracerebral haemorrhage; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
- Table 4
Outcomes of primary endpoint and secondary endpoints from the treatment groups in ITT population
Outcomes Treatment Risk difference (95% CI) Relative risk (95% CI) P value SAP (n=33) Regular CAS (n=31) Primary endpoint 0 (0.0) 3 (9.7) −9.7 (−20.1 to 0.7) NA 0.11 Secondary endpoints HPP 0 (0.0) 7 (22.6) −22.6 (−36.8 to −10.2) NA 0.04 Procedure-related adverse events 1 (3.0) 2 (6.5) −3.5 (−13.9 to 6.9) 0.64 (0.13 to 3.21) 0.61 Myocardial infarction 1 (3.0) 1 (3.2) −0.2 (−0.86 to 0.82) 0.97 (0.24 to 3.96) 1.00 Haemorrhage 30 days to 1 year 0 (0.0) 0 (0.0) NA NA 1.00 Death at 30 days 0 (0.0) 0 (0.0) NA NA 1.00 Stroke resulting in deformity 0 (0.0) 0 (0.0) NA NA 1.00 CAS, carotid artery stenting; HPP, hyperperfusion phenomenon; ITT, intent-to-treat; SAP, staged angioplasty.
Supplementary data
