Table 3.
Annualized event rates (percent) and hazard ratios for the composite outcome of cardiovascular and Kidney Events or all-cause mortality in a combined group from the ASTRAL trial and Salford observational cohort undergoing renal revascularization alongside standard of care, versus those only managed with medical standard of care. Findings are adjusted for baseline age, gender, kidney function, and other variables as per Table S1, and displayed according to subgroups of clinical phenotypes and stenosis severity.
| Population | N |
Any event (n, %) |
Annualized event rate (any event)a |
HR (95% CI) | P | P (interaction) | |||
|---|---|---|---|---|---|---|---|---|---|
| Medical | Revasc | Medical | Revasc | Medical | Revasc | ||||
| ASTRAL and Salford bilateral severe stenosis ≥ 70% | |||||||||
| All patients | 151 | 152 | 105 (69) | 84 (55) | 32.1 | 19.5 | 0.59 (0.44, 0.80) | 0.001 | 0.805 |
| All high-risk phenotypes | 119 | 121 | 86 (72) | 71 (58) | 34.8 | 21.5 | 0.60 (0.43, 0.82) | 0.002 | - |
| Heart failure including FPE | 16 | 20 | 15 (93) | 13 (65) | 85.8 | 27.2 | 0.62 (0.44, 0.88) | 0.008 | - |
| Rapid progressor | 17 | 27 | 11 (64) | 17 (62) | 27.6 | 19.8 | 0.39 (0.22, 0.71) | 0.002 | - |
| Coronary disease and diabetes | 21 | 23 | 14 (66) | 13 (56) | 23.0 | 18.2 | 0.66 (0.27, 1.60) | 0.361 | - |
| Refractory Hypertension | 60 | 70 | 44 (73) | 37 (52) | 28.7 | 17.9 | 0.59 (0.38, 0.94) | 0.025 | - |
| eGFR <30ml/min | 70 | 77 | 62 (88) | 45 (58) | 47.7 | 23.8 | 0.50 (0.34, 0.75) | 0.001 | - |
| Non-high risk | 32 | 31 | 19 (59) | 13 (41) | 23.7 | 12.8 | 0.41 (0.17, 0.96) | 0.04 | - |
| ASTRAL and Salford bilateral moderate or severe stenosis ≥ 50% | |||||||||
| All patients | 381 | 277 | 232 (60) | 157 (56) | 25.4 | 20.5 | 0.82 (0.67, 1.01) | 0.061 | 0.111 |
| All high-risk phenotypes | 298 | 212 | 195 (65) | 134 (63) | 27.9 | 24.4 | 0.86 (0.69, 1.08) | 0.187 | - |
| Heart failure including FPE | 39 | 32 | 35 (89) | 20 (62) | 75.0 | 29.7 | 0.80 (0.62, 1.02) | 0.076 | - |
| Rapid progressor | 54 | 41 | 34 (62) | 27 (65) | 22.0 | 24.4 | 0.77 (0.53, 1.12) | 0.176 | - |
| Coronary disease and diabetes | 65 | 45 | 43 (66) | 28 (62) | 25.3 | 22.1 | 0.83 (0.50, 1.36) | 0.451 | - |
| Refractory Hypertension | 145 | 113 | 89 (61) | 64 (56) | 23.5 | 19.6 | 0.86 (0.62, 1.19) | 0.357 | - |
| eGFR <30ml/min | 182 | 123 | 128 (70) | 84 (68) | 34.0 | 28.4 | 0.77 (0.58, 1.02) | 0.073 | - |
| Non-high risk | 83 | 62 | 40 (48) | 23 (37) | 17.6 | 10.6 | 0.73 (0.43, 1.25) | 0.251 | - |
| ASTRAL and Salford unilateral severe stenosis ≥70% with any disease <70% in the contralateral kidney | |||||||||
| All patients | 479 | 284 | 269 (56) | 157 (55) | 19.8 | 19.9 | 0.98 (0.81, 1.20) | 0.876 | 0.519 |
| All high-risk phenotypes | 367 | 189 | 228 (62) | 114 (60) | 22.8 | 23.0 | 0.98 (0.78, 1.23) | 0.834 | - |
| Heart failure including FPE | 51 | 19 | 43 (84) | 14 (73) | 60.3 | 33.6 | 0.90 (0.70, 1.17) | 0.446 | - |
| Rapid progressor | 67 | 26 | 46 (68) | 17 (65) | 25.5 | 25.5 | 0.87 (0.60, 1.26) | 0.463 | - |
| Coronary disease and diabetes | 70 | 55 | 49 (70) | 37 (67) | 28.3 | 26.3 | 1.02 (0.64, 1.62) | 0.941 | - |
| Refractory hypertension | 159 | 92 | 96 (60) | 49 (53) | 20.7 | 18.8 | 0.80 (0.57, 1.13) | 0.215 | - |
| eGFR <30 mL/min | 213 | 112 | 141 (66) | 76 (67) | 26.9 | 26.4 | 0.98 (0.73, 1.30) | 0.872 | - |
| Non-high risk | 112 | 92 | 41 (36) | 43 (46) | 11.4 | 14.5 | 1.18 (0.75, 1.83) | 0.476 | - |
| ASTRAL and Salford <70% stenosis both kidneys | |||||||||
| All patients | 454 | 119 | 236 (51) | 61 (51) | 17.2 | 16.5 | 1.11 (0.83, 1.48) | 0.476 | 0.642 |
| All high-risk phenotypes | 308 | 86 | 179 (58) | 48 (55) | 20.4 | 18.9 | 1.04 (0.75, 1.44) | 0.817 | - |
| Heart failure including FPE | 74 | 13 | 55 (74) | 8 (61) | 32.6 | 25.2 | 0.75 (0.5, 1.13) | 0.165 | - |
| Rapid progressor | 78 | 18 | 36 (46) | 9 (50) | 13.4 | 17.2 | 1.55 (0.95, 2.52) | 0.077 | - |
| Coronary disease and diabetes | 99 | 18 | 57 (57) | 14 (77) | 20.4 | 27.4 | 1.19 (0.64, 2.24) | 0.578 | - |
| Refractory Hypertension | 101 | 41 | 51 (50) | 20 (48) | 15.9 | 15.0 | 0.93 (0.55, 1.58) | 0.795 | - |
| eGFR <30 mL/min | 162 | 43 | 106 (65) | 26 (60) | 25.0 | 24.3 | 1.07 (0.69, 1.66) | 0.759 | - |
| Non-high risk | 146 | 33 | 57 (39) | 13 (39) | 11.4 | 11.3 | 1.38 (0.72,2.64) | 0.33 | - |
Abbreviations: eGFR, estimated glomerular filtration rate; FPE, flash pulmonary edema; HR, hazard ratio.
a
% per year.