Table 2

Outcomes compared between treatments

OutcomesGroupsNo.(%) of events or median differenceUnadjustedAdjusted*Pint† value
DAPTAlteplaseTreatment difference (95% CI)P valueTreatment difference (95% CI)P value
Primary outcome
 mRS 0–1 at 90 days‡ §ACS256/272 (94.1)266/290 (91.7)2.4 (−1.8 to 6.6)0.271.8 (−1.2 to 4.9)0.230.56
PCS62/68 (91.2)78/85 (91.8)−0.6 (−9.5 to 8.3)0.90−2.8 (−9.0 to 3.5)0.39
Secondary outcomes
 mRS 0–2 at 90 days‡ §ACS261/272 (96.0)277/290 (95.5)0.4 (−2.9 to 3.8)0.800.4 (−2.1 to 2.9)0.750.97
PCS62/68 (95.6)81/85 (95.3)0.3 (−6.3 to 6.9)0.93−0.8 (−5.4 to 3.9)0.75
 mRS distribution at 90 days‡¶ACSNANA1.12 (0.77 to 1.62)0.551.10 (0.85 to 1.42)0.490.48
PCSNANA0.78 (0.36 to 1.65)0.510.65 (0.38 to 1.09)0.10
 Early neurological deterioration within 24 hours**ACS13/274 (4.7)23/292 (7.9)−3.1 (−7.1 to 0.9)0.12−2.7 (−5.4 to 0.1)0.060.79
PCS4/68 (5.9)9/85 (10.6)−4.7 (−13.3 to 3.9)0.28−4.9 (−10.9 to 1.2)0.11
 Early neurological improvement within 24 hours‡‡ACS37/274 (13.5)70/292 (24.0)−10.5 (−16.8 to -4.1)<0.01††−7.0 (−11.3 to -2.7)<0.01††0.71
PCS10/68 (14.7)19/85 (22.4)−7.6 (−19.9 to 4.6)0.22−2.7 (−11.1 to 5.6)0.52
 Change in NIHSS score at 24 hours§§ACS0.00 (−0.41 to 0.00)0.00 (−0.69 to 0.00)−0.10 (−0.19 to −0.01)0.03††−0.08 (−0.15 to −0.02)0.01††0.71
PCS0.00 (−0.38 to 0.00)0.00 (−0.69 to 0.00)−0.06 (−0.21 to 0.08)0.40−0.06 (−0.16 to 0.05)0.28
 Stroke or other vascular events within 90 days¶¶ACS1/272 (0.4)1/290 (0.3)1.06 (0.07 to 16.96)0.971.35 (0.08 to 23.84)0.840.94
PCS0/68 (0.0)1/85 (1.2)0.02 (0.00 to NA)0.630.00 (0.00 to NA)0.98
 All-cause death at 90 days§ACS2/272 (0.7)1/290 (0.3)0.4 (−0.8 to 1.6)0.530.3 (−0.5 to 1.2)0.420.99
PCS0/68 (0.0)2/85 (2.4)−2.4 (NA to NA)0.20−2.5 (NA to NA)0.05
Safety outcomes
 sICH§ ***ACS0/274 (0.0)3/292 (1.0)−1.0 (NA to NA)0.09−1.1 (NA to NA)<0.01††0.99
PCS0/68 (0.0)1/85 (1.2)−1.2 (NA to NA)0.37−1.3 (NA to NA)0.16
 Bleeding events§†††ACS1/274 (0.4)16/292 (5.5)−5.1 (−7.8 to −2.4)<0.01††−5.3 (−7.2 to −3.3)<0.01††0.51
PCS1/68 (1.5)7/85 (8.2)−6.8 (−13.3 to −0.3)0.04††−3.7 (−7.9 to −0.5)0.03††
  • *Adjusted for participating centres and covariates compared between DAPT and alteplase treatments with p value<0.1 in each group in table 1.

  • †P value for interaction was calculated by adjusting covariates compared between ACS and PCS group with p value<0.1 in table 1.

  • ‡mRS scores ranged from 0 to 6.

  • §Calculated using generalised linear model and presented by risk difference.

  • ¶Calculated using ordinal regression analysis and presented by OR.

  • **Early neurological deterioration was defined as an increase between baseline and 24 hours of 2 on the NIHSS score, but not as a result of cerebral haemorrhage.

  • ††P value<0.05.

  • ‡‡Early neurological improvement was defined as a decrease between baseline and 24 hours of 2 on the NIHSS score.

  • §§NIHSS scores range from 0 to 42. Log (NIHSS+1) was analysed using generalised linear model and presented by geometric mean ratio.

  • ¶¶Calculated using Cox regression model and presented by HR.

  • ***Symptomatic intracranial haemorrhage was defined as any evidence of bleeding on head CT associated with neurological deterioration (NIHSS ≥4 point increase).

  • †††Bleeding events included symptomatic and asymptomatic intracerebral haemorrhage and gingival bleeding during the ARAMIS trial.

  • ACS, anterior circulation stroke; DAPT, dual antiplatelet therapy; mRS, modified Rankin Scale; N/A, not applicable; NHSS, National Institute of Health Stroke Scale; PCS, posterior circulation stroke; sICH, symptomatic intracranial haemorrhage.