Table 2. Delivery of IMP, procedural and clinical outcomes.
| Nitrite (n=40) | Placebo (n = 40) | P value | |
|---|---|---|---|
| IMP Delivery | |||
| Systolic BP drop (Median (IQR) | 8.8 (0.5-30.1) | 11.0 (2.1-21.4) | 0.90 |
| Systolic BP drop >10% | 18 (45%) | 23 (57.5%) | 0.37 |
| MetHb (Median (IQR) | 0.1 (0-0.13) | 0 (0-0.2) | 0.66 |
| Angiographic AAR | |||
| APPROACH (Mean (95% CI)) | 30.89 (28.30-33.47) | 26.63 (23.28-29.99) | 0.05 |
| BARI (Mean (95% CI)) | 27.41 (24.02-30.80) | 25.17 (22.20-28.13) | 0.32 |
| Contrast | 261.20±15.61 | 236.30±12.05 | 0.21 |
| ST segment resolution (>70%) | 5 (88.5%) | 5 (88.5%) | 0.99 |
| Manual Thrombectomy | 33 (82.5%) | 31 (77.5%) | 0.78 |
| Procedural Success | 37 (92.5%) | 38 (95.0%) | 0.62 |
| Clinical events | |||
| 48 hour | 3 (7.5) | 7 (17.5) | 0.31 |
| Death | 0 (0) | 0 (0) | |
| Recurrent Ischaemia | 0 (0) | 1 (2.5) | |
| Heart failure | 2 (5) | 3 (7.5) | |
| CIN | 1 (2.5) | 3 (7.5) | |
| 6 month | N=40 | n=40 | |
| MACE | 0 (0) | 4 (10.0) | 0.04 |
| Death | 0 (0) | 0 (0) | |
| Repeat revascularisation | 0 (0) | 2 (5.0) | |
| Recurrent myocardial infarction | 0 (0) | 1 (2.5) | |
| Hospitilisation for heart failure | 0 (0) | 1 (2.5) | |
| 1 year | N=38 | N=38 | |
| MACE | 1 (2.6%) | 6 (15.8%) | 0.04 |
| Death | 0 (0) | 0 (0) | |
| Repeat revascularisation | 1 (2.6%) | 3 (7.9) | |
| Recurrent myocardial infarction | 0 (0) | 1 (2.6) | |
| Hospitilisation for heart failure | 0 (0) | 2 (5.3) | |
| Medication at 1 year | |||
| Beta-blocker | 33 (91.7%) | 32 (88.9%) | 0.69 |
| ACE-i | 33 (91.7%) | 31 (86.1%) | 0.45 |
| ARB | 3 (8.3%) | 5 (13.9%) | 0.45 |
| Statin | 36 (100%) | 36 (100%) | 1.00 |
| Aspirin | 36 (100%) | 35 (97.2%) | 0.31 |
| ADP antagonist | 30 (83.3%) | 29 (80.6%) | 0.76 |
Values shown as number (%) unless otherwise stated.
Abbreviations: AAR, area at risk; MACE, major adverse cardiac events; CIN, contrast-induced nephropathy; IMP, investigational medicinal product