Table 2. Efficacy Outcomes at 3 Months in the Modified Intention-to-Treat Cohorta.
| Outcome | Xuesaitong group (n = 1487) | Control group (n = 1479) | OR or HR (95% CI) | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| Functional independenceb | 1328 (89.3) | 1218 (82.4) | 1.95 (1.56 to 2.44) | <.001 |
| Secondary outcomes | ||||
| Recurrent stroke | 14 (0.9) | 17 (1.1) | 0.82 (0.40 to 1.66) | .58 |
| No or minimal disability | 1102 (74.1) | 1025 (69.3) | 1.27 (1.08 to 1.49) | .004 |
| NIHSS score change from baseline to 3 mo, median (IQR)c | −4 (−5 to −3) | −4 (−5 to −3) | NA | .02 |
| Composite cerebrovascular events | 15 (1.0) | 18 (1.2) | 0.83 (0.42 to 1.65) | .59 |
| EQ-5D score, median (IQR)d | 90 (80 to 95) | 90 (80 to 95) | NA | .03 |
| Barthel Index change from baseline to 3 mo, median (IQR)e | 15 (5 to 35) | 15 (5 to 30) | NA | .006 |
| Platelet counts and coagulation indicators, median (IQR)f | ||||
| Platelet counts, ×103/μL | 216 (175 to 256) | 215 (177 to 258) | NA | .94 |
| PT, s | 11.4 (10.7 to 12.4) | 11.3 (10.6 to 12.4) | NA | .71 |
| APTT, s | 28.5 (24.5 to 32.9) | 27.9 (24.7 to 33.1) | NA | .72 |
Abbreviations: APTT, activated partial thromboplastin time; EQ-5D, EuroQoL Group 5-Dimension; HR, hazard ratio; NA, not applicable; NIHSS, National Institutes of Health Stroke Scale; PT, prothrombin time; OR, odds ratio.
SI conversion factors: To convert platelet counts to ×109/L, multiply by 1.
Data are presented as number (percentage) of patients unless otherwise indicated.
Twenty-eight patients (1.9%) in the Xuesaitong group and 26 patients (1.8%) in the control group were lost to the 3-month follow-up; the last observed follow-up data were used to replace the 3-month follow-up data based on the last-observation-carried-forward approach.
Data of NIHSS score change from baseline to 3 months were missing in 59 patients.
Data of EQ-5D score at 3 months were missing in 57 patients.
Data of Barthel Index change from baseline to 3 months were missing in 57 patients.
Data of platelet counts, PT, and APTT at 3 months were missing in 353, 402, and 414 patients, respectively. The number of missing data were similar between the 2 groups.