Cardiovascular revascularization medicine : including molecular interventions | 2021
Randomized blinded placebo-controlled trials of renal sympathetic denervation for hypertension: A meta-analysis.
Abstract
BACKGROUND\nThe efficacy of renal denervation has been controversial, but the procedure has now undergone several placebo-controlled trials. New placebo-controlled trial data has recently emerged, with longer follow-up of one trial and the full report of another trial (which constitutes 27% of the total placebo-controlled trial data). We therefore sought to evaluate the effect of renal denervation on ambulatory and office blood pressures in patients with hypertension.\n\n\nMETHODS\nWe systematically identified all blinded placebo-controlled randomized trials of catheter-based renal denervation for hypertension. The primary efficacy outcome was ambulatory systolic blood pressure change relative to placebo. A random-effects meta-analysis was performed.\n\n\nRESULTS\n6 studies randomizing 1232 patients were eligible. 713 patients were randomized to renal denervation and 519 to placebo. Renal denervation significantly reduced ambulatory systolic blood pressure (-3.52\xa0mmHg; 95% CI -4.94 to -2.09; p\xa0<\xa00.0001), ambulatory diastolic blood pressure (-1.93\xa0mmHg; 95% CI -3.04 to -0.83, p\xa0=\xa00.0006), office systolic blood pressure size (-5.10\xa0mmHg; 95% CI -7.31 to -2.90, p\xa0<\xa00.0001) and office diastolic pressure (effect size -3.11\xa0mmHg; 95% CI -4.43 to -1.78, p\xa0<\xa00.0001). Adverse events were rare and not more common with denervation.\n\n\nCONCLUSIONS\nThe totality of blinded, randomized placebo-controlled data shows that renal denervation is safe and provides genuine reduction in blood pressure for at least 6\xa0months post-procedure. If this effect continues in the long term, renal denervation might provide a life-long 10% relative risk reduction in major adverse cardiac events and 7.5% relative risk reduction in all-cause mortality.