Author + information
- Received September 3, 2018
- Revision received December 14, 2018
- Accepted December 17, 2018
- Published online April 1, 2019.
- Partha Sardar, MDa,
- Deepak L. Bhatt, MD, MPHb,
- Ajay J. Kirtane, MDc,
- Kevin F. Kennedy, MSd,
- Saurav Chatterjee, MDe,
- Jay Giri, MDf,g,
- Peter A. Soukas, MDh,
- William B. White, MDi,
- Sahil A. Parikh, MDc and
- Herbert D. Aronow, MD, MPHa,∗ (, )@herbaronowMD
- aCardiovascular Institute, Warren Alpert Medical School at Brown University, Providence, Rhode Island
- bBrigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts
- cColumbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
- dMid America Heart and Vascular Institute, St. Luke’s Hospital, Kansas City, Missouri
- eDepartment of Cardiology, Saint Francis Hospital, Teaching Affiliate, University of Connecticut School of Medicine, Hartford, Connecticut
- fPenn Cardiovascular Outcomes, Quality and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- gCardiovascular Medicine Division, University of Pennsylvania, Philadelphia, Pennsylvania
- hDivision of Cardiology, The Miriam Hospital/Warren Alpert Medical School of Brown University, Providence, Rhode Island
- iCalhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut
- ↵∗Address for correspondence:
Dr. Herbert D. Aronow, Warren Alpert Medical School of Brown University, Cardiovascular Institute, 593 Eddy Street, RIH APC 730, Providence, Rhode Island 02903.
Background There are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension.
Objectives The purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials.
Methods Databases were searched through June 30, 2018. Randomized trials (RCTs) with ≥50 patients comparing catheter-based RSD with a sham control were included. The authors calculated summary treatment estimates as weighted mean differences (WMD) with 95% confidence intervals (CIs) using random-effects meta-analysis.
Results The analysis included 977 patients from 6 trials. The reduction in 24-h ambulatory systolic blood pressure (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD −3.65 mm Hg, 95% CI: −5.33 to −1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD −4.07 mm Hg, 95% CI: −6.46 to −1.68; p < 0.001), office systolic BP (WMD −5.53 mm Hg, 95% CI: −8.18 to −2.87; p < 0.001), 24-h ambulatory diastolic BP (WMD −1.71 mm Hg, 95% CI: −3.06 to −0.35; p = 0.01), daytime ambulatory diastolic BP (WMD −1.57 mm Hg, 95% CI: −2.73 to −0.42; p = 0.008), and office diastolic BP (WMD −3.37 mm Hg, 95% CI: −4.86 to −1.88; p < 0.001). Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p interaction = 0.04); however, this interaction was not significant for 24-h ASBP (4.85 mm Hg vs. 2.23 mm Hg; p interaction = 0.13).
Conclusions RSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension.
Dr. Bhatt has served on the Advisory Board of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; has served on the Board of Directors of Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; has served as Chair of the American Heart Association Quality Oversight Committee, NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; has served on Data Monitoring Committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, and Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (COMPASS clinical trial steering committee funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has served as Deputy Editor of Clinical Cardiology; has received research funding from Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic (including for his role as co-PI of SYMPLICITY HTN-3), PhaseBio, Pfizer, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has served as a site co-investigator for Biotronik, Boston Scientific, St. Jude Medical (now Abbott), and Svelte; is a Trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, Merck, PLx Pharma, and Takeda. Dr. Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical. Dr. Giri has served on the Board of Directors for PERT Consortium, a 501c3 not-for-profit organization; has served on the Clinical Events Committee for the BEST-CLI trial sponsored by the National Institutes of Health; has served as Site Primary Investigator for the Recor Medical renal denervation trial; and has served on the Advisory Board for AstraZeneca. Dr. Parikh has served on the Advisory Board for Medtronic; and has served on the Advisory Board and Data Safety Monitoring Board for Boston Scientific (no compensation). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received September 3, 2018.
- Revision received December 14, 2018.
- Accepted December 17, 2018.
- 2019 American College of Cardiology Foundation
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