Table 2.
Outcome measures
| Total | IV-IA | IA only | P-value | |
|---|---|---|---|---|
| Primary measure outcome | ||||
| Successful revascularization (assigned as TICI >= 2b up to 3 passes) as per core lab on available data* | 84.2% (160/190)** | 84.5% (93/110) | 83.8% (67/80) | 1.000 |
| Successful revascularization (assigned as TICI >= 2b up to 3 passes) as per site investigator on available data* | 91.1% (173/190)** | 91.8% (101/110) | 90.0% (72/80) | 0.798 |
| Successful revascularization (assigned as TICI > 2b up to 3 passes) as per core lab*** | 79.2% (160/202) | 78.2% (93/119) | 80.7% (67/83) | 0.726 |
| Use of rescue treatment after study device | 8.9% (18/202) | 9.2% (11/119) | 8.4% (7/83) | 1.000 |
| Final revascularization (after rescue therapy) as per core lab**** | 88.1% (171/194) | 87.6% (99/113) | 88.9% (72/81) | 0.826 |
| Study device TICI revascularization as per core laboratory | ||||
| 0 | 4.7% (9/190) | 4.5% (5/110) | 5.0% (4/80) | 0.989 |
| 1 | 0.5% (1/190) | 0.9% (1/110) | 0.0% (0/80) | |
| 2a | 10.5% (20/190) | 10.0% (11/110) | 11.3% (9/80) | |
| 2b | 29.5% (56/190) | 29.1% (32/110) | 30.0% (24/80) | |
| 3 | 54.7% (104/190) | 55.5% (61/110) | 53.8% (43/80) | |
| Clinical outcome | ||||
| 90 day good outcome (mRS 0–2) | 57.9% (117/202) | 62.2% (74/119) | 51.8% (43/83) | 0.150 |
kappa value: 0.59
Core lab missing primary endpoint data rated as TICI 0
Core lab missing primary endpoint data of eight subjects