Table 2

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)§<0.0013.5 (1.5 to 5.6)§<0.001
 Favorable outcome56/93 (60.2)100/229 (43.7)1.38 (1.22 to 1.56)<0.0011.31 (1.18 to 1.45)<0.001
 Excellent outcome41/93 (44.1)84/229 (36.7)1.18 (0.94 to 1.49)0.141.11 (0.90 to 1.38)0.32
 90-Day mortality12/93 (12.9)50/229 (21.8)0.58 (0.37 to 0.92)0.0190.56 (0.35 to 0.88)0.011
Safety outcomes
 Any ICH38/96 (39.6)120/234 (51.3)0.77 (0.66 to 0.90)<0.0010.84 (0.71 to 1.00)0.044
 Parenchymal hematoma7/96 (7.3)45/234 (19.2)0.38 (0.22 to 0.64)<0.0010.28 (0.13 to 0.56)<0.001
 sICH5/96 (5.2)14/234 (6.0)0.87 (0.39 to 1.92)0.740.82 (0.27 to 2.46)0.72
 Procedural complications10/97 (10.3)49/239 (20.5)0.51 (0.26 to 0.99)0.0460.58 (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.