Table 2.
Primary outcome and key secondary outcomes
| GTN | Sham | acOR/aOR/aDIM/aHR (95% CI) |
P value | ||
| Day 90 mRS, maximum score of 6 (primary outcome)* | 580 | 3 [2,5] | 3 [2,5] | 1.15 (0.85, 1.54) | 0.36 |
| Sensitivity analyses | |||||
| Unadjusted | 580 | 3 [2,5] | 3 [2,5] | 0.96 (0.72, 1.28) | 0.78 |
| Mean | 580 | 3.3 (1.9) | 3.4 (1.8) | 0.08 (−0.18, 0.35) | 0.54 |
| Per protocol | 498 | 3 [2,5] | 3 [2,5] | 1.08 (0.79, 1.5) | 0.63 |
| Imputation | 597 | 3 [2,5] | 3 [2,5] | 1.12 (0.83, 1.49) | 0.46 |
| Hospital admission | |||||
| NIHSS, maximum score of 42 | 550 | 10.4 (7.1) | 10.9 (7.3) | −0.10 (−1.13, 0.92) | 0.85 |
| GCS, maximum score of 15 | 588 | 13.7 (1.9) | 13.9 (1.7) | −0.27 (−0.55, 0.00) | 0.054 |
| FAST, maximum score of 3 | 581 | 2.4 (0.9) | 2.4 (0.9) | 0.01 (−0.11, 0.13) | 0.83 |
| OCSP, TACS (%) | 586 | 111 (37.8) | 110 (37.7) | 1.05 (0.73, 1.52) | 0.79 |
| Outcomes on day 4 (or discharge) | |||||
| Death (%) | 594 | 5 (1.7) | 6 (2) | 0.82 (0.24, 2.82) | 0.75 |
| Neurological deterioration (%) | 413 | 39 (19.2) | 42 (20) | 1.02 (0.62, 1.69) | 0.93 |
| Headache, clinical (%) | 592 | 28 (9.3) | 18 (6.2) | 1.40 (0.74, 2.67) | 0.30 |
| Hypotension, clinical (%) | 593 | 12 (4) | 9 (3.1) | 1.40 (0.56, 3.49) | 0.47 |
| Hypertension, clinical (%) | 593 | 49 (16.3) | 59 (20.1) | 0.71 (0.45, 1.10) | 0.13 |
| Feeding: non-oral (%) | 576 | 79 (27.1) | 90 (31.7) | 0.86 (0.58, 1.27) | 0.45 |
| Patients with an SAE | 597 | 83 (27.5) | 71 (24.1) | 1.26 (0.86, 1.85) | 0.23 |
| Hospital events | |||||
| Length of stay (days) | 592 | 17.8 (27.2) | 19.1 (25.8) | −0.56 (−4.77, 3.65) | 0.79 |
| Died (%) | 592 | 37 (12.3) | 39 (13.4) | 1.01 (0.60, 1.70) | 0.98 |
| Died or in an institution (%) | 579 | 120 (40.8) | 118 (41.4) | 1.09 (0.76, 1.56) | 0.64 |
| Day 90 | |||||
| Death (%) | 589 | 59 (19.9) | 53 (18.2) | 1.24 (0.85, 1.81) | 0.27 |
| Disposition, maximum score of 3† | 568 | 1 (1.2) | 1 (1.2) | 1.19 (0.81, 1.74) | 0.37 |
| EQ-5D-HSUV, maximum score of 1 ‡ | 561 | 0.4 (0.4) | 0.4 (0.4) | −0.01 (−0.08, 0.05) | 0.71 |
| EQ-VAS (/100)‡ | 515 | 47.7 (33.4) | 47.6 (32) | −0.39 (−5.50, 4.73) | 0.88 |
| Barthel Index, maximum score of 100† | 557 | 58.8 (44.3) | 59.2 (43.8) | −2.88 (−9.24, 3.48) | 0.37 |
| TICS-M, maximum score of 100 ‡§ | 300 | 13.5 (12.5) | 13.4 (11.8) | −0.65 (−2.91, 1.62) | 0.58 |
| tMMSE, maximum score of 21‡§ | 307 | 11.2 (9.9) | 11.5 (9.5) | −0.91 (−2.70, 0.88) | 0.32 |
| Animal naming‡§ | 301 | 9.1 (9.6) | 9.4 (9.6) | −0.95 (−2.76, 0.86) | 0.30 |
| ZDS, maximum score of 102.5§ | 342 | 66.3 (28.5) | 65.4 (28.6) | 2.63 (−2.61, 7.86) | 0.33 |
| Global analysis, Wei-Lachin§ | 300 | – | – | 0.00 (−0.10, 0.09) | 0.92 |
| Global analysis, Wei-Lachin with imputation | 597 | – | – | −0.01 (−0.09, 0.07) | 0.82 |
| Home time (days) | 471 | 59.1 (48.3) | 55.4 (45.4) | 1.93 (−5.69, 9.54) | 0.62 |
Data are number (%), mean (SD) or median [IQR]. Comparison by binary logistic regression, Cox proportional hazards regression, ordinal logistic regression or multiple linear regression, with adjustment for age, sex, premorbid mRS, FAST, pretreatment systolic BP, index event (haemorrhagic stroke, ischaemic stroke, TIA, mimic) and time to randomisation (unless stated). The effect of treatment for GTN versus sham is shown as acOR, aOR, aHR, or aDIM, with 95% CIs.
*Increased OR, that is, >1, indicates a shift to worse functional outcome.
†Disposition: home (score of 1), institution or in hospital (score of 2), died (score of 3) by day 90.
‡Death assigned: BI −5, animal naming −1, EQ-VAS −1, home time −1, tMMSE −1, TICS-M −1, EQ-5D HUS 0, GCS 2, NIHSS 43, ZDS 102.5.
§Some participants with poor outcomes or dysphasia could not answer cognition and mood questions.
acOR, adjusted common OR; aDIM, adjusted difference in means; aHR, adjusted HR; aOR, adjusted OR; BI, Barthel Index; BP, blood pressure; EQ-5D, EuroQoL-5 dimension 3 level; FAST, Face-Arm-Speech-Time; GCS, Glasgow Coma Scale; GTN, glyceryl trinitrate; HSUV, health status utility value; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; OCSP, Oxfordshire community stroke project; SAE, serious adverse event; TACS, total anterior circulation syndrome; TIA, transient ischaemic attack; TICS-M, Telephone Interview Cognition Scale-Modified; t-MMSE, telephone modified Mini-Mental State Examination; VAS, Visual Analogue Scale; ZDS, Zung Depression Scale.