Table 3.
Outcomes of patients enrolled in the NITRATE-CIN study
| Treatment group | Unadjusted | Covariate adjusteda | ||||
|---|---|---|---|---|---|---|
| Placebo | Inorganic nitrate | |||||
| CIN | n = 282 | n = 274 | Odds Ratio (95% CI) | P value | Odds Ratio (95% CI) | P value |
| CIN n (%) | 86 (30.50) | 25 (9.12) | 0.23 (0.14 to 0.37) | <.001 | 0.21 (0.13 to 0.34) | <.001 |
| Creatinine (mmol/L) | 112.7 (49.6) | 110.1 (43.0) | ||||
| eGFR (mL/min/1.73 m2) | 59.6 (21.1) | 60.3 (20.8) | ||||
| 3 month | n = 215 | n = 206 | Difference (95% CI) | P value | Difference (95% CI) | P value |
|---|---|---|---|---|---|---|
| Creatinine (mmol/L) Mean ± SD | ||||||
| Baseline | 97.3 (32.2) | 107.3 (38.3) | ||||
| 3-month | 109.6 (41.8) | 108.8 (41.5) | −0.74 (−8.72 to 7.24) | .855 | −10.42 (−14.98 to −5.86) | <.001 |
| Change | 12.3 (25.8) | 1.5 (20.9) |
| 3 month | n = 210 | n = 205 | Difference (95% CI) | P value | Difference (95% CI) | P value |
|---|---|---|---|---|---|---|
| eGFR Mean ± SD (mL/min/1.73 m2) | n = 210 | n = 205 | ||||
| Baseline | 66.4 (18.1) | 60.6 (18.1) | ||||
| 3-month | 59.9 (18.5) | 60.5 (17.8) | 0.62 (−2.89 to 4.12) | .730 | 5.17 (2.94 to 7.39) | <.001 |
| Change | −6.58 (12.9) | −0.12 (11.1) |
| 1 Year MACE | n = 320 | n = 318 | Odds Ratio (95% CI) | P value | Odds Ratio (95% CI) | P value |
|---|---|---|---|---|---|---|
| MACE | 58 (18.13) | 29 (9.12) | 0.45 (0.28 to 0.73) | .001 | 0.45 (0.28 to 0.73) | .001 |
| All-cause mortality | 35 (10.94) | 17 (5.35) | 0.46 (0.25 to 0.84) | .011 | 0.46 (0.25 to 0.84) | .011 |
| Cardiovascular mortality | 12 (3.75) | 8 (2.52) | 0.66 (0.27 to 1.64) | .374 | 0.66 (0.27 to 1.64) | .375 |
| Non-fatal MI | 25 (7.81) | 10 (3.14) | 0.38 (0.18 to 0.81) | .031 | 0.38 (0.18 to 0.81) | .012 |
| Unscheduled revascularisation | 15 (4.69) | 5 (1.57) | 0.32 (0.12 to 0.90) | .031 | 0.32 (0.12 to 0.90) | .031 |
| 1 year MAKE | n = 320 | n = 318 | Odds Ratio (95% CI) | P value | Odds Ratio (95% CI) | P value |
|---|---|---|---|---|---|---|
| MAKE | 91 (28.44) | 34 (10.69) | 0.30 (0.20 to 0.46) | <.001 | 0.30 (0.19 to 0.46) | <.001 |
| All-cause mortality | 35 (10.94) | 17 (5.35) | 0.46 (0.25 to 0.84) | .011 | 0.46 (0.25 to 0.84) | .011 |
| New-onset RRT | 5 (1.56) | 3 (0.94) | 0.60 (0.14 to 2.53) | .487 | 0.60 (0.14 to 2.55) | .490 |
| Persistent Renal Dysfunction | 62 (19.38) | 18 (5.66) | 0.25 (0.14 To 0.43) | <.001 | 0.25 (0.14 To 0.43) | <.001 |
Kidney function at 3 months and 1-year Major adverse cardiac events (MACE) [excluding procedural mis] and Major adverse kidney events (MAKE) are listed. Data is shown as odds ratio with 95% confidence interval (CI) or mean value ± standard deviation (SD) or a number (percentage). MI, Myocardial Infarction; RRT, Renal replacement therapy.
aAdjusted differences are corrected for diabetes status with 3-month renal function measures also adjusting for baseline measures.