Table 2.
Characteristics of responders (dASBP drop ≥ 5 mmHg).
| Renal denervation | Sham procedure | |||||
|---|---|---|---|---|---|---|
| Characteristics | Responder (N = 44) |
Non-Responder (N = 20) |
p value | Responder (N = 15) |
Non-Responder (N = 43) |
p value |
| Age (years) | 52.3 ± 10.0 | 58.7 ± 8.7 | 0.017 | 51.1 ± 9.7 | 55.0 ± 10.2 | 0.202 |
| Male | 68.2% (30/44) | 50.0% (10/20) | 0.164 | 60.0% (9/15) | 62.8% (27/43) | 0.848 |
| Black Race | 13.6% (6/44) | 15.0% (3/20) | 0.884 | 20.0% (3/15) | 16.3% (7/43) | 0.743 |
| BMI (kg/m2) | 30.0 ± 5.8 | 29.5 ± 6.7 | 0.733 | 29.8 ± 6.8 | 29.7 ± 4.4 | 0.953 |
| Abdominal obesitya | 59.1% (26/44) | 47.4% (9/19) | 0.390 | 53.3% (8/15) | 69.8% (30/43) | 0.249 |
| Baseline eGFR (ml/min/1.73 m2)a | 82.2 ± 13.3 | 86.4 ± 16.9 | 0.288 | 86.3 ± 17.4 | 82.1 ± 13.7 | 0.343 |
| Sleep apnea | 11.4% (5/44) | 5.0% (1/20) | 0.418 | 13.3% (2/15) | 11.6% (5/43) | 0.861 |
| Hemoglobin A1c (%)a | 5.4 ± 0.7 | 5.5 ± 0.4 | 0.641 | 5.6 ± 0.9 | 5.5 ± 0.5 | 0.699 |
| Antihypertensive Medications at Screening (yes vs. no) | 86.4% (38/44) | 75.0% (15/20) | 0.264 | 66.7% (10/15) | 79.1% (34/43) | 0.334 |
| Baseline orthostatic hypertension | 27.3% (12/44) | 5.0% (1/20) | 0.040 | 20.0% (3/15) | 16.3% (7/43) | 0.743 |
| Baseline office systolic BP (mmHg) | 153.6 ± 11.9 | 157.0 ± 15.1 | 0.341 | 146.0 ± 14.1 | 154.6 ± 15.8 | 0.068 |
| Baseline office diastolic BP (mmHg) | 99.8 ± 7.2 | 100.3 ± 9.8 | 0.827 | 94.2 ± 8.5 | 99.6 ± 9.8 | 0.062 |
| Baseline daytime systolic ABP (mmHg) | 150.5 ± 7.7 | 150.5 ± 6.5 | 0.995 | 148.0 ± 8.6 | 150.1 ± 10.3 | 0.472 |
| Baseline daytime diastolic ABP (mmHg) | 93.9 ± 4.7 | 92.5 ± 3.5 | 0.262 | 93.0 ± 4.8 | 93.3 ± 5.6 | 0.855 |
| Baseline nighttime systolic ABP (mmHg)a | 130.5 ± 12.7 | 130.9 ± 11.7 | 0.909 | 130.8 ± 15.6 | 131.7 ± 13.2 | 0.828 |
| Baseline nighttime diastolic ABP (mmHg)a | 78.7 ± 8.4 | 78.4 ± 7.4 | 0.918 | 80.0 ± 7.8 | 80.0 ± 7.4 | 0.997 |
| 24-H systolic ABP (mmHg) | 142.5 ± 8.4 | 143.6 ± 6.9 | 0.638 | 141.7 ± 10.3 | 143.7 ± 10.8 | 0.534 |
| 24-H diastolic ABP (mmHg) | 87.9 ± 5.1 | 87.4 ± 3.9 | 0.691 | 88.2 ± 4.7 | 88.6 ± 5.6 | 0.807 |
| Baseline office pulse pressure (mmHg) | 53.8 ± 10.0 | 56.7 ± 12.4 | 0.327 | 51.8 ± 10.0 | 55.0 ± 12.4 | 0.374 |
| Baseline 24-H ambulatory pulse pressure (mmHg) | 54.6 ± 7.3 | 56.1 ± 6.7 | 0.432 | 53.5 ± 9.3 | 55.1 ± 9.2 | 0.565 |
| Baseline office heart rate (bpm) | 71.8 ± 11.9 | 72.9 ± 14.2 | 0.757 | 68.1 ± 8.8 | 71.8 ± 12.9 | 0.315 |
| Baseline 24-H ambulatory heart rate (bpm) | 72.6 ± 7.7 | 73.1 ± 14.1 | 0.871 | 71.5 ± 10.2 | 70.5 ± 9.8 | 0.725 |
| Total number of ablations | 5.5 ± 1.0 | 5.5 ± 0.8 | 0.773 | |||
| Average main artery diameter left (mm) | 5.5 ± 0.7 | 5.4 ± 0.9 | 0.623 | |||
| Average main artery diameter right (mm) | 5.4 ± 0.7 | 5.0 ± 0.7 | 0.053 | |||
| Vessel length (left renal) (mm) | 38.0 ± 12.8 | 38.8 ± 11.6 | 0.807 | |||
| Vessel length (right renal) (mm) | 43.7 ± 11.7 | 47.0 ± 12.4 | 0.317 | |||
| Presence of any untreated accessory | 15.9% (7/44) | 45.0% (9/20) | 0.013 | |||
| Presence of side branches proximal to ablations | 15.9% (7/44) | 10.0% (2/20) | 0.528 | |||
| Farthest distance bilaterally from distal ablation to parenchyma | 19.2 ± 9.9 | 17.4 ± 8. | 0.487 | |||
| Operator case number | 1.9 ± 1.5 | 2.3 ± 1.3 | 0.332 | |||
| Contrast volume used (cc)a | 145.5 ± 64.3 | 119.8 ± 72.6 | 0.168 | |||
| Duration of procedure (min) | 72.0 ± 21.1 | 65.9 ± 25.3 | 0.320 | |||
| Fluoro time (min)a | 13.0 ± 4.3 | 14.1 ± 8.8 | 0.589 | |||
| Paradise catheter time (min) | 32.9 ± 18.1 | 33.0 ± 17.0 | 0.985 | |||
| Number of different balloon sizes used in patient | 1.8 ± 0.8 | 1.5 ± 0.6 | 0.114 | |||
Data displayed as % (n/N) and mean ± standard deviation.
ABP ambulatory blood pressure, BMI body mass index, BP blood pressure, eGFR estimated glomerular filtration rate.
aContrast volume was missing from one patient and flouro time was missing from three patients in the renal denervation responder group. Abdominal obesity status and contrast volume each had one patient with missing data in the renal denervation non-responder group. eGFR, Nighttime SBP and Nighttime DBP each had one patient with missing data and hemoglobin A1C had two patients with missing data in the sham non-responder group.
Statistically significant p-values are in bold.