Table 2.
BP During Screening and Prerandomization
| All Patients With Implantion(n=68) | Withdrawn at the End of Run‐in Because of BP Criterion (n=21) | All Randomized Following Run‐in (n=47) | P (Withdrawn vs Randomized) | Control (n=21) | Treatment (n=26) | P (Control vs Treatment) | |
|---|---|---|---|---|---|---|---|
| Screening | |||||||
| ISH | 57 (83.8) | 19 (90.5) | 38 (80.9) | 0.482 | 15 (71.4) | 23 (88.5) | 0.263 |
| oSBP, mm Hg | 162.6±14.5 | 161.3±14.4 | 163.1±14.6 | 0.654 | 165.2±15.3 | 161.4±14.1 | 0.381 |
| oDBP, mm Hg | 82.0±10.4 | 80.7±10.1 | 82.5±10.6 | 0.522 | 82.4±13.0 | 82.6±8.5 | 0.955 |
| oHeart rate, beats per min | 64.7±13.4 | 66.1±15.5 | 65.9±10.9 | 0.586 | 63.7±16.6 | 64.4±8.3 | 0.860 |
| aSBP, mm Hg (d) | 142.0±10.3 | 140.3±8.3 | 142.8±11.1 | 0.36 | 145.2±12.5 | 140.7±9.5 | 0.168 |
| aDBP, mm Hg (d) | 76.0±8.1 | 75.8±8.8 | 76.1±7.9 | 0.889 | 76.8±5.7 | 75.6±5.7 | 0.605 |
| aHeart rate, beats per min (d) | 67.3±10.6 | 69.9±9.7 | 66.1±10.9 | 0.17 | 66.3±12.8 | 65.9±9.3 | 0.886 |
| aSBP, mm Hg (night) | 132.1±17.1 | 122.3±13.0 | 136.6±16.9 | 0.001 | 138.2±17.3 | 135.2±16.9 | 0.558 |
| aDBP, mm Hg (night) | 68.8±9.4 | 65.3±9.5 | 70.4±9.0 | 0.037 | 71.5±11.2 | 69.4±6.6 | 0.438 |
| aHeart rate, beats per min (night) | 60.7±9.4 | 61.1±9.0 | 60.5±9.7 | 0.809 | 61.3±13.1 | 59.8±5.9 | 0.624 |
| aSBP, mm Hg (24 h) | 139.1±10.3 | 135.0±8.0 | 141.0±10.8 | 0.025 | 143.1±11.2 | 139.2±10.3 | 0.231 |
| aDBP, mm Hg (24 h) | 74.0±7.7 | 72.8±8.3 | 74.5±7.5 | 0.409 | 75.3±9.7 | 73.8±5.0 | 0.497 |
| aHeart rate, beats per min (24 h) | 65.4±9.9 | 67.4±9.2 | 64.5±10.2 | 0.275 | 65.0±12.6 | 64.1±8.0 | 0.775 |
| Three‐wk run‐in phase | |||||||
| aSBP, mm Hg (d) | 133.1±13.4 | 122.0±11.3 | 137.9±11.3 | <0.001 | 137.9±12.4 | 137.9±10.6 | 0.988 |
| aDBP, mm Hg (d) | 73.3±7.8 | 69.6±8.4 | 74.9±7.1 | 0.011 | 74.2±6.9 | 75.4±7.3 | 0.565 |
| aHeart rate, beats per min (d) | 70.2±9.2 | 69.7±6.5 | 70.5±10.2 | 0.756 | 69.6±9.4 | 71.2±10.9 | 0.614 |
| aSBP, mm Hg (night) | 126.9±14.2 | 114.5±10.5 | 132.2±12.2 | <0.001 | 132.0±14.5 | 132.4±10.1 | 0.919 |
| aDBP, mm Hg (night) | 67.5±8.2 | 63.4±7.9 | 69.3±7.7 | 0.006 | 68.1±7.6 | 70.2±7.8 | 0.367 |
| aHeart rate, beats per min (night) | 65.1±6.4 | 64.9±5.8 | 65.2±6.7 | 0.828 | 64.9±6.3 | 65.5±7.2 | 0.761 |
| aSBP, mm Hg (24 h) | 131.5±13.0 | 120.1±10.7 | 136.3±10.7 | <0.001 | 136.3±12.5 | 136.3±9.2 | 0.995 |
| aDBP, mm Hg (24 h) | 71.8±7.5 | 68.0±7.9 | 73.3±6.8 | 0.007 | 72.6±6.7 | 74.0±6.9 | 0.478 |
| aHeart rate, beats per min (24 h) | 68.9±8.2 | 68.5±6.2 | 69.1±9.0 | 0.786 | 68.4±8.5 | 69.6±9.5 | 0.670 |
| Four‐wk run‐in phase | |||||||
| oSBP, mm Hg | 150.2±16.5 | 141.0±15.5 | 153.7±15.6 | 0.005 | 154.4±15.5 | 153.1±15.9 | 0.773 |
| oDBP, mm Hg | 80.9±11.4 | 77.0±10.7 | 82.3±11.4 | 0.092 | 81.6±12.4 | 82.9±10.7 | 0.706 |
| oHeart rate, beats per min | 66.8±10.5 | 66.9±7.8 | 66.8±11.4 | 0.987 | 66.5±10.9 | 67.1±12.1 | 0.847 |
| Response to acute CNT activation, mm Hg | −15.0±10.2 | −15.2±9.6 | 0.955 | ||||
Values are mean±SD or number (percentage). aDBP indicates ambulatory diastolic blood pressure; aSBP, ambulatory systolic blood pressure; BP, blood pressure; CNT, cardiac neuromodulation therapy; ISH, isolated systolic hypertension; oDBP, office diastolic blood pressure; and oSBP, office systolic blood pressure.