Outcomes compared between treatments
Outcomes | Groups | No.(%) of events or median difference | Unadjusted | Adjusted* | Pint† value | |||
DAPT | Alteplase | Treatment difference (95% CI) | P value | Treatment difference (95% CI) | P value | |||
Primary outcome | ||||||||
mRS 0–1 at 90 days‡ § | ACS | 256/272 (94.1) | 266/290 (91.7) | 2.4 (−1.8 to 6.6) | 0.27 | 1.8 (−1.2 to 4.9) | 0.23 | 0.56 |
PCS | 62/68 (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‡ § | ACS | 261/272 (96.0) | 277/290 (95.5) | 0.4 (−2.9 to 3.8) | 0.80 | 0.4 (−2.1 to 2.9) | 0.75 | 0.97 |
PCS | 62/68 (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‡¶ | ACS | NA | NA | 1.12 (0.77 to 1.62) | 0.55 | 1.10 (0.85 to 1.42) | 0.49 | 0.48 |
PCS | NA | NA | 0.78 (0.36 to 1.65) | 0.51 | 0.65 (0.38 to 1.09) | 0.10 | ||
Early neurological deterioration within 24 hours** | ACS | 13/274 (4.7) | 23/292 (7.9) | −3.1 (−7.1 to 0.9) | 0.12 | −2.7 (−5.4 to 0.1) | 0.06 | 0.79 |
PCS | 4/68 (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‡‡ | ACS | 37/274 (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 |
PCS | 10/68 (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§§ | ACS | 0.00 (−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 |
PCS | 0.00 (−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¶¶ | ACS | 1/272 (0.4) | 1/290 (0.3) | 1.06 (0.07 to 16.96) | 0.97 | 1.35 (0.08 to 23.84) | 0.84 | 0.94 |
PCS | 0/68 (0.0) | 1/85 (1.2) | 0.02 (0.00 to NA) | 0.63 | 0.00 (0.00 to NA) | 0.98 | ||
All-cause death at 90 days§ | ACS | 2/272 (0.7) | 1/290 (0.3) | 0.4 (−0.8 to 1.6) | 0.53 | 0.3 (−0.5 to 1.2) | 0.42 | 0.99 |
PCS | 0/68 (0.0) | 2/85 (2.4) | −2.4 (NA to NA) | 0.20 | −2.5 (NA to NA) | 0.05 | ||
Safety outcomes | ||||||||
sICH§ *** | ACS | 0/274 (0.0) | 3/292 (1.0) | −1.0 (NA to NA) | 0.09 | −1.1 (NA to NA) | <0.01†† | 0.99 |
PCS | 0/68 (0.0) | 1/85 (1.2) | −1.2 (NA to NA) | 0.37 | −1.3 (NA to NA) | 0.16 | ||
Bleeding events§††† | ACS | 1/274 (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 |
PCS | 1/68 (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.