title: Meta-analysis of randomized controlled trials of renal denervation in treatment-resistant hypertension.
abstract: OBJECTIVE
  The blood pressure (BP)-lowering effect of renal sympathetic nervous denervation (RDN) in resistant hypertension (rHT) shows large variation among studies.
  
  
  METHODS
  We meta-analyzed summary statistics of randomized clinical trials on RDN in rHT. For continuous outcomes, we assessed heterogeneity by Cochran's Q 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.
  
  
  RESULTS
  Of 5652 patients screened in seven trials, 985 (17.4%) qualified and were randomized to control (n = 397) or RDN with SYMPLICITY(™) catheters (n = 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 (p = 0.24).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Departments of Cardiology, Internal Medicine and Medical Biochemistry, Oslo University Hospital , Ullevaal, Oslo , Norway.
authors.forename: Fadl Elmula M
authors.initials: FE
authors.lastname: Fadl Elmula
authors.forename: Yu
authors.initials: Y
authors.lastname: Jin
authors.forename: Wen-Yi
authors.initials: WY
authors.lastname: Yang
authors.forename: Lutgarde
authors.initials: L
authors.lastname: Thijs
authors.forename: Yi-Chao
authors.initials: YC
authors.lastname: Lu
authors.forename: Anne C
authors.initials: AC
authors.lastname: Larstorp
authors.forename: Alexandre
authors.initials: A
authors.lastname: Persu
authors.forename: Marc
authors.initials: M
authors.lastname: Sapoval
authors.forename: Ján
authors.initials: J
authors.lastname: Rosa
authors.forename: Petr
authors.initials: P
authors.lastname: Widimský
authors.forename: Lotte
authors.initials: L
authors.lastname: Jacobs
authors.forename: Jean
authors.initials: J
authors.lastname: Renkin
authors.forename: Ondřej
authors.initials: O
authors.lastname: Petrák
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.forename: Jiři
authors.initials: J
authors.lastname: Widimský
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.forename: Michel
authors.initials: M
authors.lastname: Azizi
authors.forename: Sverre E
authors.initials: SE
authors.lastname: Kjeldsen
authors.forename: Jan A
authors.initials: JA
authors.lastname: Staessen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D005260:Female; D006801:Humans; D006973:Hypertension / Q000503:physiopathology / Q000601:surgery* / Q000628:therapy; D007668:Kidney / Q000294:innervation* / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D013562:Sympathectomy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents
keywords: Blood pressure-lowering treatment; meta-analysis; randomized clinical trial; renal sympathetic nervous denervation; resistant hypertension