Table 2.
Primary and secondary effectiveness and safety outcome in READAPT, CHANCE, POINT, and THALES.
| Outcome | READAPT* | CHANCE 6 | POINT 7 | THALES 8 |
|---|---|---|---|---|
| Sample size | 1920 | 2584 | 2432 | 5493 |
| Primary outcomes | ||||
| Primary effectiveness outcome†, N (%) | 74 (3.9) | 212 (8.2) | 121 (5.0) | 303 (5.5) |
| Primary safety outcome§ N (%) | 12 (0.6) | 7 (0.3) | 23 (0.9) | 28 (0.5) |
| Key secondary outcomes | ||||
| Ischemic event, N (%) | 64 (3.3) | 243 (9.4) | 112 (4.6) | 276 (5.0) |
| Ischemic stroke | 38 (2.0) | 204 (7.9) | 112 (4.6) | 276 (5.0) |
| TIA | 26 (1.3) | 39 (1.5) | NA | NA |
| Hemorrhagic transformation, N (%) | 19 (1.0) | NA | NA | NA |
| Symptomatic | 2 (0.1) | |||
| Asymptomatic | 17 (0.9) | |||
| Intracranial hemorrhage, N (%) | 3 (0.2) | 8 (0.3) | 5 (0.2) | 22 (0.4) |
| Subarachnoid hemorrhage, N (%) | 2 (0.1) | NA | NA | NA |
| Other intracranial hemorrhage, N (%) | 2 (0.1) | NA | NA | NA |
| Myocardial infarction, N (%) | 3 (0.2) | 3 (0.1) | 10 (0.4) | NA |
| Death, N (%) | 8 (0.5) | 10 (0.4) | 18 (0.7) | 36 (0.7) |
| Vascular | 3 (0.2) | 6 (0.2) | 6 (0.2) | |
| Non-vascular | 5 (0.3) | 4 (0.2) | 12 (0.5) | |
| Severe bleeding, N (%) | 9 (0.5) | 4 (0.2) | 17 (0.7) | 28 (0.5) |
| Moderate bleeding, N (%) | 3 (0.2) | 3 (0.1) | NA | 36 (0.7%) a |
| Mild bleeding, N (%) | 40 (2.1) | 30 (1.2) | 40 (1.6) | 36 (0.7%) a |
| Any bleeding, N (%) | 52 (2.7) | 60 (2.3) | NA | NA |
| Hospitalization, N (%) | 63 (3.3) | NA | NA | NA |
| mRS, median (IQR) | 0 (0–1) | NA | NA | NA |
mRS: modified Rankin scale; NA: not available; N: Number; TIA: transient ischemic attack.
a
Moderate or mild bleeding.
*
All patients were evaluable for the analysis.
†
Primary efficacy outcome in CHANCE was new stroke event (ischemic or hemorrhagic), in POINT was the composite of ischemic stroke, myocardial infarction, or death from ischemic vascular causes, and in THALES was the composite of stroke (ischemic stroke, hemorrhagic stroke) or death.
§
Primary safety outcome in CHANCE was moderate-severe bleeding event, in POINT was major hemorrhage, and in THALES was severe bleeding event.