Table 2.
Primary and main secondary outcomes at days 4 and 90 in participants diagnosed with a stroke mimic. Data are number (%), median [IQR], or mean (standard deviation)
| N | GTN | Sham | aOR/aMD (95% CI), adjusted | p-value | |
|---|---|---|---|---|---|
| Day 90 mRS (/6) | |||||
| All | 274 | 3 [1,4] | 3 [1,4] | 0.5 (0.3, 0.9) | 0.008 |
| Sensitivity analyses | |||||
| Per-protocol | 245 | 3 [1,4] | 3 [1,4] | 0.6 (0.4, 0.9) | 0.026 |
| With multiple imputation | 297 | 3 [1,4] | 3 [1,4] | 0.6 (0.4, 0.9) | 0.013 |
| mean mRS | 274 | 2.5 (1.7) | 2.8 (1.9) | −0.5 (− 0.8, − 0.1) | 0.012 |
| mRS, unadjusted | 274 | 3 [1,4] | 3 [1,4] | 0.8 (0.5, 1.2) | 0.27 |
| mRS > 2 (%) | 274 | 72 (58.1) | 91 (60.7) | 0.6 (0.3, 1.2) | 0.18 |
| mRS > 2, unadjusted (%) | 274 | 72 (58.1) | 91 (60.7) | 0.9 (0.6, 1.5) | 0.66 |
| mRS, Received thrombolysis | 8 | 1 [1,2] | 1 [0,1] | – | – |
| mRS, No thrombolysis | 266 | 3 [1,4] | 3 [1,4] | 0.6 (0.4, 0.9) | 0.013 |
| Admission | |||||
| NIHSS (/42) | 176 | 5.7 (6.2) | 5.3 (5.3) | −0.2 (−1.8, 1.4) | 0.82 |
| FAST (hospital admission) [/3] | 186 | 1.4 (1.1) | 1.5 (1.0) | −0.2 (− 0.5, 0.1) | 0.19 |
| OCSP, TACS (%) | 224 | 15 (15.8) | 25 (19.4) | 0.8 (0.4, 1.7) | 0.57 |
| GCS admission | 241 | 14.4 (1.4) | 14.2 (1.8) | 0.3 (−0.1, 0.7) | 0.13 |
| Day 4 (or discharge) | |||||
| Death (%) | 279 | 2 (1.6) | 1 (0.6) | 2.2 (0.2, 29.8) | 0.56 |
| Patients with an SAE (%) | 279 | 6 (4.8) | 10 (6.5) | 0.8 (0.3, 2.5) | 0.73 |
| Infection (%) | 275 | 11 (8.9) | 17 (11.3) | 0.5 (0.2, 1.2) | 0.13 |
| Neurological deterioration (%) | 52 | 2 (7.7) | 3 (11.5) | 0.1 (0.0, 10.4) | 0.27 |
| Neurological deterioration, clinical (%) | 275 | 6 (4.8) | 4 (2.6) | 2.3 (0.6, 9.4) | 0.25 |
| Headache (%) | 274 | 8 (6.5) | 8 (5.3) | 1.4 (0.5, 4.1) | 0.54 |
| Hypotension, SBP < 90 mmHg (%) | 274 | 3 (2.4) | 0 (0) | – | – |
| Hypertension, SBP > 180 mmHg (%) | 274 | 17 (13.8) | 15 (9.9) | 2.1 (0.9, 4.9) | 0.090 |
| Feeding: non-oral (%) | 243 | 7 (6.4) | 7 (5.3) | 1.1 (0.4, 3.5) | 0.87 |
| Glasgow coma scale (/15) | 114 | 14.2 (2.5) | 14.2 (2.7) | 0.1 (−0.9, 1.1) | 0.79 |
| NIHSS (/43) | 57 | 4.5 (10.9) | 4.9 (9.7) | −0.6 (−6.4, 5.3) | 0.85 |
| Hospital events | |||||
| Length of stay (days) | 279 | 4.8 (8.5) | 5 (6.9) | −0.6 (−2.4, 1.1) | 0.48 |
| Died in hospital (%) | 279 | 6 (4.8) | 3 (1.9) | 3.7 (0.8, 17.1) | 0.098 |
| Died or discharged to institution (%) | 271 | 13 (10.8) | 19 (12.6) | 0.8 (0.3, 1.7) | 0.49 |
| Day 90 | |||||
| Death (%) | 281 | 8 (6.3) | 19 (12.3) | 0.5 (0.2, 1.2) | 0.11 |
| Disposition (%) | 260 | 1 [1,1] | 1 [1,1] | 0.6 (0.3, 1.2) | 0.14 |
| EQ-5D HUS (/1) | 257 | 0.5 (0.4) | 0.5 (0.4) | 0.1 (0.0, 0.2) | 0.031 |
| Quality of life, EQ-VAS (/100) | 240 | 57.3 (25.8) | 51.9 (30.3) | 6.5 (−0.2, 13.3) | 0.057 |
| Barthel Index (/100) | 253 | 75.2 (35.1) | 71.7 (39.2) | 6.3 (−1.4, 14.0) | 0.11 |
| Disability, Barthel index < 60 (%) | 253 | 27 (23.9) | 33 (23.6) | 0.9 (0.4, 1.9) | 0.73 |
| TICS-M | 112 | 19.3 (10.5) | 15 (11.0) | 3.3 (−0.0, 6.5) | 0.052 |
| tMMSE | 116 | 15.5 (8.0) | 12.7 (9.0) | 2.4 (−0.1, 4.9) | 0.061 |
| Animal naming | 114 | 14.7 (9.5) | 11.8 (10.1) | 1.7 (−1.3, 4.7) | 0.26 |
| Zung Depression Scale (/100) | 139 | 62.5 (24.3) | 62.4 (27.1) | −2.3 (−9.9, 5.3) | 0.55 |
| Home time (days) | 221 | 91 (36.2) | 85.7 (39.7) | 6.3 (−3.0, 15.7) | 0.19 |
| Global analysis | 112 | – | – | −0.1 (−0.2, 0.0) | 0.15 |
aMD adjusted mean difference, aOR adjusted odds ratio, CI confidence interval, EQ-5D HUS EuroQol EQ-5D Health utility scores, FAST face-arm-speech test, GCS Glasgow Coma Scale, GTN glyceryl trinitrate, mmHg millimetres of mercury, MI multiple imputation, mRS modified Rankin Scale, NIHSS National Institutes of Health Stroke Scale, OCSP Oxford Community Stroke Project classification, PP per protocol analysis, SAE serious adverse event, TACS total anterior circulation stroke, TICS-M Telephone Interview for Cognitive Status -Modified, t-MMSE modified telephone Mini-Mental State Examination