Table 3. Safety and Secondary Outcomes.
| Outcome | No. (%) of Patients | Difference, % (95% CI) | ||
|---|---|---|---|---|
| All (n = 198) |
3-D Stent Retriever With Aspiration (n = 98) |
Aspiration Alone (n = 100) |
||
| Device-related SAE at 24 h | 9/198 (4.5) | 4/98 (4.1) | 5/100 (5.0) | −0.92 (−6.71 to 4.88) |
| Procedure-related SAE at 24 h | 24/198 (12.1) | 10/98 (10.2) | 14/100 (14.0) | −3.80 (−12.86 to 5.27) |
| All-cause mortality at 90 d | 45/198 (22.7) | 19/98 (19.4) | 26/100 (26.0) | −6.61 (−18.24 to 5.01) |
| Symptomatic ICH within 24 h | 8/198 (4.0) | 3/98 (3.1) | 5/100 (5.0) | −1.94 (−7.40 to 3.53) |
| 30-d Good clinical outcomea | 113/197 (57.4) | 58/97 (59.8) | 55/100 (55.0) | 4.79 (−9.00 to 18.59) |
| 90-d mRS score 0-2 | 83/182 (45.6) | 39/86 (45.3) | 44/96 (45.8) | −0.48 (−14.98 to 14.01) |
| 90-d Good neurologic outcomeb | 111/182 (61.0) | 56/86 (65.1) | 55/96 (57.3) | 7.82 (−6.30 to 21.94) |
Abbreviations: ICH, intracranial hemorrhage; mRS, modified Rankin Scale; SAE, serious adverse event; 3-D, 3-dimensional.
a
Indicates a National Institutes of Health Stroke Scale (NIHSS) score of no more than 1 or at least a 10.0-point improvement at discharge (range, −28 to 27, with positive values indicating less impairment at discharge), or a 30-d mRS score of no more than 2 (range, 0 to 6, with higher scores indicating greater functional disability).
b
Indicates an mRS score of no more than 2 or at least a 10.0-point improvement on the NIHSS score.