Table 2. Change in Ambulatory, Home, and Office Blood Pressure Levels at 2 Months Compared With Baseline.
| Observed data | Baseline-adjusted for observed data | Baseline-adjusted with multiple imputations for missing data | Median between-group difference (95% CI)c | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ultrasound renal denervation, mean (SD) | Sham procedure, mean (SD) | ||||||||||
| At baseline | At 2 mo | Difference | At baseline | At 2 mo | Difference | Mean between-group difference (95% CI)a | P valueb | Mean between-group difference (95% CI)a | P valueb | ||
| Systolic blood pressure, mm Hg | |||||||||||
| Daytime ambulatoryd | 150.2 (8.6) | 142.3 (13.4) | −7.9 (11.6) | 151.3 (9.0) | 149.5 (11.1) | −1.8 (9.5) | −6.3 (−9.4 to −3.2) | <.001 | −6.3 (−9.3 to −3.2) | <.001 | −7.0 (−9.0 to −4.0)e |
| 24-h ambulatoryf | 143.2 (9.0) | 135.6 (13.0) | −7.7 (10.7) | 144.5 (9.7) | 142.9 (10.5) | −1.7 (9.3) | −6.3 (−9.2 to −3.4) | <.001 | −6.2 (−9.1 to −3.4) | <.001 | |
| Nighttime ambulatoryf | 132.1 (12.6) | 125.5 (15.0) | −6.6 (12.8) | 133.8 (13.3) | 132.4 (12.2) | −1.3 (11.3) | −5.9 (−9.1 to −2.6) | <.001 | −5.8 (−9.0 to −2.6) | <.001 | −6.0 (−9.0 to −3.0)e |
| Homeg | 152.4 (9.5) | 143.4 (12.3) | −9.0 (9.5) | 149.7 (10.3) | 148.8 (12.3) | −0.9 (7.9) | −7.8 (−10.4 to −5.1) | <.001 | −7.6 (−10.1 to −5.0) | <.001 | |
| Officeh | 156.8 (13.3) | 145.8 (15.9) | −11.0 (13.5) | 156.7 (12.9) | 151.2 (16.4) | −5.5 (12.9) | −5.5 (−9.2 to −1.8) | .004 | −5.4 (−9.0 to −1.8) | .004 | |
| Diastolic blood pressure, mm Hg | |||||||||||
| Daytime ambulatoryd | 93.8 (5.2) | 88.4 (7.4) | −5.4 (6.5) | 93.2 (5.6) | 91.8 (6.7) | −1.3 (5.7) | −3.9 (−5.6 to −2.2) | <.001 | −3.9 (−5.6 to −2.2) | <.001 | |
| 24-h ambulatoryf | 88.4 (5.8) | 83.1 (7.6) | −5.3 (6.4) | 88.2 (5.8) | 87.0 (6.3) | −1.2 (5.4) | −4.1 (−5.7 to −2.4) | <.001 | −4.1 (−5.7 to −2.4) | <.001 | |
| Nighttime ambulatoryf | 79.8 (8.3) | 75.1 (9.7) | −4.7 (8.2) | 80.2 (8.0) | 79.6 (7.5) | −0.5 (6.7) | −4.3 (−6.3 to −2.2) | <.001 | −4.2 (−6.3 to −2.2) | <.001 | −5.0 (−7.0 to −3.0)e |
| Homeg | 97.8 (6.3) | 92.7 (7.4) | −5.1 (6.0) | 95.7 (7.6) | 95.5 (8.1) | −0.3 (4.5) | −4.4 (−6.0 to −2.9) | <.001 | −4.3 (−5.9 to −2.8) | <.001 | |
| Officeh | 101.9 (7.8) | 96.0 (10.2) | −5.9 (9.4) | 101.4 (7.5) | 98.1 (11.2) | −3.3 (9.2) | −2.4 (−5.1 to 0.2) | .07 | −2.3 (−4.9 to 0.2) | .08 | |
Estimate of treatment difference used baseline-adjusted analysis of covariance.
Calculated using baseline-adjusted analysis of covariance.
Data provided because change from baseline in either cohort was not normal. These data were calculated using the Hodges-Lehmann estimator of location shift without adjustment for baseline data or multiple imputations.
There were 145 patients in the ultrasound renal denervation group and 73 patients in the sham procedure group with data.
The P value comparison for these data yielded a value of P<.001 and was calculated using baseline-adjusted analysis of covariance based on ranks and using observed data without multiple imputations.
There were 144 patients in the ultrasound renal denervation group and 72 patients in the sham procedure group with data.
There were 140 patients in the ultrasound renal denervation group and 69 patients in the sham procedure group with data.
There were 137 patients in the ultrasound renal denervation group and 71 patients in the sham procedure group with data.