Comparison of efficacy and safety outcomes according to first pass effect in the ASTER trial
| Outcomes | FPE (n=97) | Non-FPE (n=239) | RR (95% CI)* | P value* | RR (95% CI)† | P value† |
| Efficacy outcomes | ||||||
| ∆ NIHSS at 24 hours, mean (95% CI)‡ | 7.6 (5.8 to 9.3) | 4.0 (2.8 to 5.1) | 3.6 (1.5 to 5.7)§ | <0.001 | 3.5 (1.5 to 5.6)§ | <0.001 |
| Favorable outcome | 56/93 (60.2) | 100/229 (43.7) | 1.38 (1.22 to 1.56) | <0.001 | 1.31 (1.18 to 1.45) | <0.001 |
| Excellent outcome | 41/93 (44.1) | 84/229 (36.7) | 1.18 (0.94 to 1.49) | 0.14 | 1.11 (0.90 to 1.38) | 0.32 |
| 90-Day mortality | 12/93 (12.9) | 50/229 (21.8) | 0.58 (0.37 to 0.92) | 0.019 | 0.56 (0.35 to 0.88) | 0.011 |
| Safety outcomes | ||||||
| Any ICH | 38/96 (39.6) | 120/234 (51.3) | 0.77 (0.66 to 0.90) | <0.001 | 0.84 (0.71 to 1.00) | 0.044 |
| Parenchymal hematoma | 7/96 (7.3) | 45/234 (19.2) | 0.38 (0.22 to 0.64) | <0.001 | 0.28 (0.13 to 0.56) | <0.001 |
| sICH | 5/96 (5.2) | 14/234 (6.0) | 0.87 (0.39 to 1.92) | 0.74 | 0.82 (0.27 to 2.46) | 0.72 |
| Procedural complications | 10/97 (10.3) | 49/239 (20.5) | 0.51 (0.26 to 0.99) | 0.046 | 0.58 (0.32 to 1.04) | 0.067 |
Values expressed as no/total no (%), unless otherwise stated
*Calculated using the non-FPE group as reference, after prespecified adjustment for center, first-line MT strategy and intravenous rtPA.
†Calculated using the non-FPE group as reference after adjustment for center, first-line MT strategy, intravenous rtPA, significant baseline differences (except clot length) and onset to groin puncture time.
‡Mean change (95% CI) adjusted on baseline NIHSS score, center, first-line MT strategy and intravenous rtPA.
§Adjusted mean difference (FPE vs non-FPE).
FPE, first pass effect; ICH, intracranial hemorrhage; MT, mechanical thrombectomy; NIHSS, National Institutes of Health Stroke Scale; RR, risk ratio; rtPA, recombinant tissue plasminogen activator; sICH, symptomatic intracranial hemorrhage.