Table 2.
Procedural and outcomes data.
|
Tonbridge group
(n = 104) |
Solitaire group
(n = 104) |
P | |
|---|---|---|---|
| Bridging intravenous fibrinolysis, no. (%) | 18 (17.3%) | 19 (18.3%) | 0.856 |
| Retriever in conjunction with aspiration, no. (%) | 4 (3.8%) | 7 (6.7%) | 0.353 |
| Number of passes by retriever, median | 1.5 | 1 | 0.641 |
| Balloon and/or stent angioplasty, no. (%) | 26 (25.0%) | 16 (15.4%) | 0.084 |
| Primary outcome:Final successful reperfusion, no. (%) |
96 (92.3%) |
88 (84.6%) |
<0.0001a |
| mTICI 2b/3 with a first pass, no. (%) | 50 (48.1%) | 46 (44.2%) | 0.578b |
| mTICI 3 with a first pass, no. (%) | 19 (18.3%) | 20 (19.2%) | 0.859b |
| mTICI 2b/3 before angioplasty, no. (%) | 90 (86.5%) | 85 (81.7%) | 0.343b |
|
Secondary outcomes: Time from groin puncture to successful reperfusion—min, median (IQR) NIHSS at 24 h, median (IQR)c NIHSS at 7 days, median (IQR)d mRS 0–2 at 90 days, no. (%) mRS at 90 days, median (IQR) |
67.5 (46.5–95.5) 10 (4–15) 6 (2–13) 61 (58.7%) 2 (1–4) |
67 (44.0–99.0) 8 (4–16) 4 (1–13) 64 (61.5%) 2 (1–4) |
0.970 0.993 0.777 0.671 1.000 |
| Postprocedure mTICI, no. (%) | |||
| 0 1 2a 2b 3 |
1 (1.0%) 3 (2.9%) 4 (3.8%) 64 (61.5%) 32 (30.8%) |
4 (3.8%) 3 (2.9%) 9 (8.7%) 58 (55.8%) 30 (28.8%) |
0.3138 |
|
Major safety outcomes: Symptomatic intracranial hemorrhage within 24 h, no. (%)e Death within 90 days, no. (%) |
2 (1.9%) 14 (13.5%) |
5 (5.0%) 17 (16.3%) |
0.238 0.559 |
mTICI, the modified thrombolysis in cerebral infarction score; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale.
a
The p-value was for noninferiority and calculated by the CMH chi-square test.
b
The p-value was for difference and calculated by the chi-square test.
c
Data were missing for one patient in the Tonbridge group and four patients in the Solitaire group.
d
Data were missing for seven patients in the Tonbridge group and 11 patients in the Solitaire group.
e
Data were missing for one patient in the Tonbridge group and three patients in the Solitaire group.