Meta-analysis of randomized controlled trials of renal denervation in treatment-resistant hypertension. (October 2015)

• Record Type: Journal Article
• Authors: Fadl Elmula, Fadl Elmula M.; Jin, Yu; Yang, Wen-Yi; Thijs, Lutgarde; Lu, Yi-Chao; Larstorp, Anne C.; Persu, Alexandre; Sapoval, Marc; Rosa, Ján; Widimský, Petr; Jacobs, Lotte; Renkin, Jean; Petrák, Ondřej; Chatellier, Gilles; Shimada, Kazuyuki; Widimský, Jiři; Kario, Kazuomi; Azizi, Michel; Kjeldsen, Sverre E.; Staessen, Jan A.; For The European Network Coordinating Research On Renal Denervation (ENCOReD) Consortium
• Is Part Of: Blood pressure. Volume 24:Number 5(2015)
• Page Start: 263
• Page End: 274
• Publication Date: 2015-10
• Subjects: Blood pressure -- Periodicals; Hypertension -- Periodicals; Hypertension -- Periodicals; Blood Pressure -- Periodicals; 612.14
• DOI: 10.3109/08037051.2015.1058595
• Languages: English
• ISSNs: 0803-7051

Abstract

<abstract> <title>Abstract</title> <p> <italic>Objective</italic>. The blood pressure (BP)-lowering effect of renal sympathetic nervous denervation (RDN) in resistant hypertension (rHT) shows large variation among studies. <italic>Methods.</italic> We meta-analyzed summary statistics of randomized clinical trials on RDN in rHT. For continuous outcomes, we assessed heterogeneity by Cochran's <italic>Q</italic> test and used random-effect models weighted for the inverse of the variance. We assessed safety by assessing the risk of major adverse events from stratified contingency tables. <italic>Results.</italic> Of 5652 patients screened in seven trials, 985 (17.4%) qualified and were randomized to control (<italic>n</italic> = 397) or RDN with SYMPLICITY<sup>™</sup> catheters (<italic>n</italic> = 588). Follow-up was 6 months. In both control and RDN patients, antihypertensive treatment was continued or optimized. At enrolment, age averaged 58.1 years, systolic/diastolic office and 24 h BP 168.5/93.3 mmHg and 151.8/86.1 mmHg, respectively, and estimated glomerular filtration rate (eGFR) 79.3 ml/min/1.73 m². For BP outcomes, there was heterogeneity among trials. Pooled effects (control minus RDN) were −4.9/−3.5 mmHg (95% confidence interval, −20.9 to 11.1/−8.9 to 1.9) for office BP, −2.8/−1.5 mmHg (−6.5 to 0.8/−3.3 to 0.4) for 24 h BP and 0.81 ml/min/1.73 m² (−1.69 to 3.30) for eGFR. Removing one trial at a time produced confirmatory results. Adverse events occurred in 7.4% and 9.9% of control and RDN patients, respectively (<italic>p</italic> = 0.24). <italic>Conclusion.</italic> In selected rHT patients maintained on antihypertensive drugs, RDN with the SYMPLICITY systems does not significantly decrease BP but is safe. Future trials with next-generation catheters should aim at identifying responders in patients with evidence of sympathetic nervous overactivity.</p> </abstract>