Table 2. Primary and Secondary Trial Outcomes.
| Outcomes | ICC | No. of cases/total No. (%) | Primary analysisa | Covariate-adjusted analysisb | |||
|---|---|---|---|---|---|---|---|
| Intervention | Control | ARD (95% CI) | AOR (95% CI) | ARD (95% CI) | AOR (95% CI) | ||
| Primary outcome | |||||||
| Reperfusion therapy among patients who arrived within 3.5 or 4.5 h of symptom onset | 0.28 | 3046/5689 (53.5) | 2830/6443 (43.9) | 7.8 (−7.3 to 23.0) | 1.37 (0.74 to 2.52) | 5.5 (−8.0 to 19.0) | 1.26 (0.72 to 2.21) |
| Secondary outcomes | |||||||
| IV rtPA among patients who arrived within 3.5 h of symptom onset | 0.28 | 2830/5540 (51.1) | 2612/6316 (41.4) | 8.9 (−6.4 to 24.2) | 1.43 (0.77 to 2.66) | 6.7 (−7.0 to 20.5) | 1.33 (0.75 to 2.36) |
| EVT among patients who arrived within 4.5 h of symptom onset | 0.36 | 270/739 (36.5) | 236/772 (30.6) | 0.8 (−11.7 to 13.4) | 1.05 (0.57 to 1.95) | 0.4 (−10.1 to 11.0) | 0.99 (0.57 to 1.71) |
| DNT within 60 min | 0.22 | 2018/2830 (71.3) | 1701/2612 (65.1) | 7.5 (−6.0 to 21.0) | 1.44 (0.76 to 2.75) | 7.1 (−5.3 to 19.4) | 1.39 (0.77 to 2.54) |
| DPT within 90 min | 0.23 | 62/270 (23.0) | 86/236 (36.4) | −25.6 (−40.6 to −10.7) | 0.26 (0.12 to 0.57) | −18.4 (−29.4 to −7.3) | 0.27 (0.14 to 0.52) |
| In-hospital death | 0.14 | 146/5689 (2.6) | 165/6443 (2.6) | −0.2 (−1.3 to 0.9) | 0.92 (0.58 to 1.45) | −0.3 (−1.2 to 0.6) | 0.93 (0.61 to 1.41) |
| Disability at 90 dc | 0.02 | 1215/4687 (25.9) | 1439/5711 (25.2) | −1.3 (−5.4 to 2.9) | 0.94 (0.75 to 1.16) | −0.9 (−5.1 to 3.2) | 0.96 (0.77 to 1.20) |
Abbreviations: AOR, adjusted odds ratio; ARD, adjusted risk difference; DNT, door-to-needle time; DPT, door-to-puncture time; EVT, endovascular thrombectomy; ICC, intracluster correlation; IV rtPA, intravenous recombinant tissue plasminogen activator.
Results were yielded from generalized estimating equation logistic regression models and adjusted for the hospital clustering effect and temporal trend (period).
Results were yielded from generalized estimating equation logistic regression models and adjusted for the hospital clustering effect, temporal trend (period), and imbalanced baseline covariates (medical history of stroke or transient ischemic attack, medication history of antiplatelet agent and statin, and hospital location).
A total of 1423 of 11 821 patients discharged alive (12.0%; 856 of 5543 [15.4%] in the intervention period vs 567 of 6278 [9.0%] in the control period) had missing modified Rankin Scale scores because of loss of follow-up.