The effect of catheter-based sham renal denervation in hypertension: systematic review and meta-analysis

BMC Cardiovascular Disorders

Research

Fausto J Pinto¹  Adriana Fernandes²  Daniel Caldeira³  Joaquim J Ferreira⁴  João Costa⁴  Cláudio David⁵ 

[1] Faculdade de Medicina, Centro Cardiovascular da Universidade de Lisboa (CCUL@RISE), Universidade de Lisboa, Lisbon, Portugal;Cardiology Department, Hospital Santa Maria, Centro Hospitalar Univesitário Lisboa Norte (CHULN), Centro Académico de Medicina de Lisboa (CAML), Lisbon, Portugal;Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal;Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal;Faculdade de Medicina, Centro Cardiovascular da Universidade de Lisboa (CCUL@RISE), Universidade de Lisboa, Lisbon, Portugal;CNS – Campus Neurológico Sénior, Torres Vedras, Portugal;CEMBE (Centro de Estudos de Medicina Baseada na Evidência, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal;Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal;Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal;Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal;Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal;Faculdade de Medicina, Centro Cardiovascular da Universidade de Lisboa (CCUL@RISE), Universidade de Lisboa, Lisbon, Portugal;

关键词: Hypertension;    Placebo;    Renal denervation;    Renal sympathetic denervation;    Sham;   

DOI  :  10.1186/s12872-023-03269-w

 received in 2022-12-13, accepted in 2023-04-27,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundRenal denervation (RDN) has emerged in recent years as a possible treatment for hypertension. The first sham-controlled trial showed a small magnitude and non-significant in the blood pressure (BP) lowering effect, also due to a substantial decrease of BP in sham arm. Considering this, we aimed to quantify the magnitude of BP decrease within the sham arm of Randomized Controlled Trials (RCT) with RDN in patients with hypertension.MethodsElectronic databases were searched since inception until January 2022 for randomized sham-controlled trials which assessed the efficacy in lowering BP of the sham intervention for catheter-based RDN in adult patients with hypertension. The outcomes were change in ambulatory/office systolic and diastolic BP.ResultsA total of 9 RCT were included in the analysis enrolling a total of 674 patients. Sham intervention showed a decrease in all evaluated outcomes. Office systolic BP had a reduction of -5.52 mmHg [95%CI -7.91, -3.13] and office diastolic BP of -2.13 mmHg [95%CI -3.08, -1.17]. Sham procedure for RDN also showed a reduction of -3.41 mmHg [95%CI -5.08, -1.75] in ambulatory systolic BP and − 2.44 mmHg [95%CI -3.31, -1.57] in ambulatory diastolic BP.ConclusionDespite recent data indicating that RDN might be an effective treatment for patients with resistant hypertension when compared to a sham intervention, our results indicate that the sham intervention for RDN also has a significant effect on lowering Office and Ambulatory (24-h) Blood Pressure in adult patients with hypertension. This highlights that BP itself might be sensitive to placebo-like effect and also brings further difficulties in establishing the BP lowering efficacy of invasive interventions due to the magnitude of the sham effect.

【 授权许可】

CC BY   
© The Author(s) 2023

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