Table 2.
Primary and secondary outcomes according to t48 pupillometry thresholds
| qPLR ≥ 4%, n = 494 |
qPLR < 4%, n = 46 |
P value | NPi > 2, n = 523 |
NPi ≤ 2, n = 20 |
P value | |
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| CPC 3–5, unfavorable outcome at follow-up, n (%)a | 172/494 (35) | 45/46 (98) | < 0.001 | 200/523 (38) | 20/20 (100) | < 0.001 |
| Median CPC at follow-up (IQR)a | 1 (1–5) | 5 (5–5) | < 0.001 | 1 (1–5) | 5 (5–5) | < 0.001 |
| CPC 3–5, unfavorable outcome at follow-up (extracerebral deaths excluded), n (%)a | 136/451 (30) | 42/43 (98) | < 0.001 | 164/480 (34) | 17/17 (100) | < 0.001 |
| Secondary outcomes | ||||||
| Death from any cause within 365 days, n (%) | 160/494 (33) | 43/46 (93) | < 0.001 | 186/523 (36) | 20/20 (100) | < 0.001 |
| mRS 3–6, unfavorable outcome at follow-up, n (%)b | 182/494 (37) | 45/46 (98) | < 0.001 | 210/523 (40) | 20/20 (100) | < 0.001 |
| Median mRS score at follow-up (IQR)b | 1 (0–6) | 6 (6–6) | < 0.001 | 1 (0–6) | 6 (6–6) | < 0.001 |
| Median MOCA score at follow-up (IQR)c | 27 (24–29) | NAd | NAd | 27 (24–29) | NAd | NAd |
| Median 48-h plasma NSE level (IQR), μg/liter | 18 (11–34) | 56 (34–127) | < 0.001 | 19 (11–39) | 45 (29–70) | 0.004 |
Occurrences of primary and secondary outcomes according to the specific qPLR and NPi thresholds measured at t48. Follow-up was after 90 days according to the detailed description in the methods section
qPLR percentage pupillary constriction in response to a calibrated light stimulus indicated as quantitatively assessed pupillary light reflex, NPi Neurological Pupil index, AUC area under the curve, CPC Cerebral Performance Category, mRS modified Rankin scale score, MOCA Montreal Cognitive Assessment, NSE neuron-specific enolase, IQR Interquartile range
aCPC ranges from 1 (no symptoms) to 5 (death); a category of 3 or 4 indicates severe disability or a coma or vegetative state
bmRS scores range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 death
cMOCA scores range from 0 to 30, with a score of 26 or higher being normal. For the score at 3 months (per protocol), the lowest score found in the trial population was assigned to patients unavailable for follow-up, including deceased patients
dOnly one patient with qPLR < 4, and no patients NPi ≤ 2, had MOCA score available