Randomized Trials of Renal Denervation for Uncontrolled Hypertension: An Updated Meta‐Analysis

Abstract

Background Despite optimal medical therapy, a significant proportion of patients' blood pressure remains uncontrolled. Catheter‐based renal denervation (RDN) has been proposed as a potential intervention for uncontrolled hypertension. We conducted an updated meta‐analysis to assess the efficacy and safety of RDN in patients with uncontrolled hypertension, with emphasis on the differential effect of RDN in patients on and off antihypertensive medications. Methods and Results Online databases were searched to identify randomized clinical trials comparing efficacy and safety of RDN versus control in patients with uncontrolled hypertension. Subgroup analyses were conducted for sham‐controlled trials and studies that used RDN devices that have gained or are currently seeking US Food and Drug Administration approval. Fifteen trials with 2581 patients (RDN, 1723; sham, 858) were included. In patients off antihypertensive medications undergoing RDN, a significant reduction in 24‐hour ambulatory (−3.70 [95% CI, −5.41 to −2.00] mm Hg), office (−4.76 [95% CI, −7.57 to −1.94] mm Hg), and home (−3.28 [95% CI, −5.96 to −0.61] mm Hg) systolic blood pressures was noted. In patients on antihypertensive medications, a significant reduction was observed in 24‐hour ambulatory (−2.23 [95% CI, −3.56 to −0.90] mm Hg), office (−6.39 [95% CI, −11.49 to −1.30]), home (−6.08 [95% CI, −11.54 to −0.61] mm Hg), daytime (−2.62 [95% CI, −4.14 to −1.11]), and nighttime (−2.70 [95% CI, −5.13 to −0.27]) systolic blood pressures, as well as 24‐hour ambulatory (−1.16 [95% CI, −1.96 to −0.35]), office (−3.17 [95% CI, −5.54 to −0.80]), and daytime (−1.47 [95% CI, −2.50 to −0.27]) diastolic blood pressures. Conclusions RDN significantly lowers blood pressure in patients with uncontrolled hypertension, in patients off and on antihypertensive medications, with a favorable safety profile. The efficacy of RDN was consistent in sham‐controlled trials and contemporary trials using US Food and Drug Administration–approved devices.