Efficacy endpoints and procedure details
| Catfish group (n=113) | Solitaire group (n=114) | Rate difference (95% CI) | Non-inferiority P value | |
| Primary efficacy endpoint | ||||
| Successful recanalisation at the end of the procedure | ||||
| Per-treatment | 100 (88.5) | 100 (87.7) | 0.78 (–7.64 to 9.20) | 0.001 |
| Per-protocol | 98 (90.7; n=108) | 98 (89.9; n=109) | 0.83 (–7.03 to 8.70) | <0.001 |
| Secondary efficacy endpoints | ||||
| Time from arterial puncture to final reperfusion, min | 81.6 (46.2) | 82.2 (58.8) | NA | NA |
| mTICI 2b/3 after first pass | 58 (51.8; n=112) | 61 (54.0; n=113) | NA | NA |
| 2b | 16 (14.2) | 27 (23.9) | NA | NA |
| 3 | 42 (37.5) | 34 (30.0) | NA | NA |
| Successful recanalisation with study device | ||||
| Per-treatment | 87 (88.8; n=98) | 85 (89.5; n=95) | –0.70 (–9.48 to 8.08) | 0.004 |
| Per-protocol | 86 (91.5; n=94) | 84 (92.3; n=91) | –0.82 (–8.68 to 7.04) | 0.002 |
| Use of rescue treatment | NA | NA | ||
| Balloon angioplasty | 8 (53.3; n=15) | 7 (36.8; n=19) | ||
| Stent implantation | 4 (26.7; n=15) | 9 (47.4; n=19) | ||
| Balloon angioplasty+stent implantation | 3 (20.0; n=15) | 3 (15.8; n=19) | ||
| NIHSS score at 24 hours | 15.8 (11.3; n=109) | 13.8 (9.3; n=111) | NA | NA |
| NIHSS score at 7 days | 13.4 (12.0; n=111) | 11.5 (10.3; n=113) | NA | NA |
| Good neurological outcome at 90 days (mRS score of 0–2) | ||||
| Per-treatment | 54 (47.8) | 57 (50.0) | NA | NA |
| Per–protocol | 53 (49.1; n=108) | 55 (50.5; n=109) | NA | NA |
Data are mean (SD), n (%) or median (IQR).
The successful recanalisation rate after procedure completion in the Catfish group was non-inferior to that of the Solitaire group for per-treatment analysis; the common OR was 0.78 (95% CI, –7.64 to 9.20; p=0.001).
mRS, modified Rankin Scale; mTICI, modified thrombolysis in cerebral infarction; NIHSS, National Institutes of Health Stroke Scale; Per-protocol, per-protocol analysis; Per-treatment, per-treatment analysis.