Table 1.
Summary of SYMPLICITY HTN‐1 and HTN‐2 Clinical Trials
| HTN‐1 [N = 153] | HTN‐2 [N = 106] | |
|---|---|---|
| Trial design | Multicenter, prospective, open‐label (pooled analysis of first‐in‐man and phase I studies) | Multicenter, open‐label, randomized trial; n = 52 randomized to immediate RDN, n = 54 controls |
| Patient age (mean ± SD), y | 57 ± 11 | 58 ± 12 |
| No. antihypertensive medications | 5.1 ± 1.5 | 5.2 ± 1.5 (RDN), 5.3 ± 1.8 (control) |
| Antihypertensive use by class at baseline | ||
| ACE inhibitor/ARB | 91% | 95% |
| β‐blocker | 82% | 75% |
| CCB | 75% | 81% |
| Diuretic | 95% | 89% |
| Mean baseline blood pressure (mean ± SD), mm Hg | 176/98 ± 17/14 | 178/96 ± 18/16 (RDN), 178/97 ± 17/16 (control) |
| Reduction in blood pressure | −25/−11 (at 6 months; n = 86), −32/−14 (at 24 months; n = 18) | −32/−12 (RDN group at 6 months; n = 49),a +1/0 (control group at 6 months; n = 51) |
Abbreviations: ACE, angiotensin‐converting enzyme; ARB, angiotensin‐receptor blocker; CCB, calcium channel blocker; RDN, renal denervation; SD = standard deviation.
a
P < 0.0001 for difference between RDN and control systolic and diastolic blood pressure reductions.