Table 2.
Secondary outcomes at days 7 and 90
|
Glyceryl trinitrate vs no glyceryl trinitrate analysis |
Continue vs stop analysis |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Glyceryl trinitrate (n=2000) | No glyceryl trinitrate (n=2011) | OR or MD (95% CI) | Two-sided p value | N | Continue (n=1053) | Stop (n=1044) | OR or MD (95% CI) | Two-sided p value | |
| Day 7 (or discharge) | ||||||||||
| Death, all cause | 4001 | 61 (3%) | 58 (3%) | 1·12 (0·76–1·64) | 0·57 | 2095 | 34 (3%) | 27 (3%) | 1·18 (0·69–2·00) | 0·55 |
| SSS score (out of 58) | 3991 | 39·1 (16) | 38·5 (16) | 0·62 (−0·38 to 1·61)* | 0·46 | 2088 | 37·1 (17) | 38·4 (16) | −1·25 (−2·65 to 0·16)* | 0·28 |
| Neurological deterioration† | 3991 | 177 (9%) | 194 (10%) | 0·88 (0·71–1·10) | 0·28 | 2088 | 107 (10%) | 105 (10%) | 1·00 (0·74–1·34) | 0·99 |
| Recurrent stroke‡ | 3997 | 42 (2%) | 31 (2%) | 1·37 (0·85–2·20) | 0·19 | 2093 | 30 (3%) | 18 (2%) | 1·64 (0·90–3·00) | 0·10 |
| Symptomatic intracranial haemorrhage‡ | 4000 | 22 (1%) | 18 (1%) | 1·20 (0·63–2·29) | 0·59 | 2095 | 12 (1%) | 11 (1%) | 1·03 (0·43–2·44) | 0·95 |
| Headache‡ | 4000 | 360 (18%) | 170 (9%) | 2·39 (1·96–2·92) | <0·0001 | 2095 | 123 (12%) | 117 (11%) | 1·11 (0·84–1·47) | 0·46 |
| Hypotension‡ | 4000 | 53 (3%) | 15 (1%) | 3·55 (1·99–6·35) | <0·0001 | 2095 | 24 (2%) | 16 (2%) | 1·58 (0·82–3·02) | 0·17 |
| Hypertension‡ | 4000 | 138 (7%) | 155 (8%) | 0·87 (0·68–1·11) | 0·26 | 2095 | 60 (6%) | 94 (9%) | 0·65 (0·46–0·92) | 0·015 |
| Serious adverse event | 4011 | 271 (14%) | 261 (13%) | 1·05 (0·88–1·26) | 0·59 | 2097 | 147 (14%) | 155 (15%) | 0·93 (0·73–1·19) | 0·56 |
| Discharge data | ||||||||||
| Median hospital stay (days) | 3985 | 11 (7–25) | 11 (7–25) | −0·34 (−1·81 to 1·12)* | 1·00 | 2086 | 12 (7–28) | 11 (7–26) | 1·20 (−0·88 to 3·28)* | 0·32 |
| Death or institution | 3986 | 716 (36%) | 761 (38%) | 1·08 (0·94–1·25) | 0·29 | 2086 | 450 (43%) | 389 (37%) | 0·76 (0·62–0·93) | 0·008 |
| Day 90 | ||||||||||
| Death | 3996 | 233 (12%) | 263 (13%) | 0·89 (0·72–1·10) | 0·27 | 2091 | 167 (16%) | 146 (14%) | 1·09 (0·83–1·42) | 0·54 |
| Death or institution | 3980 | 554 (28%) | 604 (30%) | 0·88 (0·75–1·03) | 0·11 | 2083 | 365 (35%) | 323 (31%) | 0·85 (0·69–1·06) | 0·15 |
| Barthel index (out of 100) | 3970 | 66 (38) | 63 (39) | 2·18 (−0·23 to 4·59)* | 0·11 | 2076 | 58 (41) | 62 (39) | −3·83 (−7·29 to 0·38)* | 0·098 |
| Barthel index <60 | 3970 | 654 (33%) | 699 (35%) | 0·90 (0·76–1·06) | 0·19 | 2076 | 425 (41%) | 365 (35%) | 1·28 (1·02–1·59) | 0·031 |
| t-MMSE score | 2506 | 11 (7) | 11 (7) | 0·33 (−0·22 to 0·88)* | 0·13 | 1272 | 9 (7) | 10 (7) | −0·91 (−1·70 to 0·12)* | 0·013 |
| TICS-M score | 2322 | 22·43 (14·93) | 22·1 (15·49) | 0·33 (−0·91 to 1·57)* | 0·85 | 1179 | 19·1 (15·23) | 21·11 (15·.08) | −2·11 (−3·84 to 0·37)* | 0·044 |
| Verbal fluency score | 2366 | 9·31 (7·73) | 9·21 (7·93) | 0·1 (−0·53 to 0·73)* | 0·82 | 1201 | 7·82 (7·48) | 8·66 (7·54) | −0·84 (−1·7 to 0·01)* | 0·15 |
| Health utility status | 3952 | 0·49 (0·32) | 0·48 (0·33) | 0·01 (−0·01 to 0·03)* | 0·87 | 2063 | 0·44 (0·33) | 0·47 (0·33) | −0·03 (−0·06 to 0·00)* | 0·24 |
| EQ-VAS | 3440 | 56·5 (30.8) | 55·7 (31·6) | 0·79 (−1·29 to 2·88)* | 0·70 | 1759 | 51·8 (32·4) | 54·2 (31·6) | −2·42 (−5·41 to 0·57)* | 0·15 |
| ZDS | 3253 | 58·3 (23.7) | 58·8 (24·6) | −0·50 (−2·15 to 1·16)* | 0·82 | 1659 | 62·0 (24·9) | 61·1 (24·6) | 0·94 (−1·44 to 3·32)* | 0·43 |
| Serious adverse event | 4011 | 510 (26%) | 499 (25%) | 1·04 (0·90–1·20) | 0·62 | 2097 | 308 (29%) | 286 (27%) | 1·10 (0·91–1·33) | 0·35 |
Data are number of patients (%) or mean (SD). OR=odds ratio. MD=mean difference. SSS=Scandinavian stroke scale. mRS: modified Rankin scale. t-MMSE=modified telephone mini-mental state examination. TICS-M=modified telephone interview for cognitive status. EQ=EuroQol. VAS=visual analogue scale. ZDS=Zung depression scale.
*
Values are MD.
†
Neurological deterioration was a decrease in SSS by more than 5 points and decrease in consciousness on SSS by more than 2 points.
‡
Clinical events determined by the investigator.