Author + information
- Received July 25, 2019
- Revision received September 24, 2019
- Accepted October 15, 2019
- Published online February 17, 2020.
- Michael A. Weber, MDa,∗ (, )
- Ajay J. Kirtane, MD, SMb,c,
- Matthew R. Weir, MDd,
- Jai Radhakrishnan, MDb,
- Tony Das, MDe,
- Martin Berk, MDe,
- Farrell Mendelsohn, MDf,
- Alain Bouchard, MDf,
- German Larrain, MDg,
- Michael Haase, MDg,
- Juan Diaz-Cartelle, MDh and
- Martin B. Leon, MDb,c
- aState University of New York, Downstate Medical Center, Brooklyn, New York
- bColumbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York
- cCardiovascular Research Foundation, New York, New York
- dUniversity of Maryland School of Medicine, Baltimore, Maryland
- eTexas Health Presbyterian Hospital, Dallas, Texas
- fBaptist Medical Center Princeton, Cardiology PC Research, Birmingham, Alabama
- gAspirus Heart and Vascular Institute, Wausau, Wisconsin
- hBoston Scientific, Marlborough, Massachusetts
- ↵∗Address for correspondence:
Dr. Michael A. Weber, Division of Cardiovascular Medicine, SUNY Downstate College of Medicine, 450 Clarkson Avenue, Brooklyn, New York 10021.
Objectives The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline.
Background A blood pressure–reducing effect of renal denervation has been difficult to isolate in clinical investigations.
Methods REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension) was a randomized, sham-controlled multicenter trial. Patients with office systolic blood pressure (SBP) of 150 to 180 mm Hg and average 24-h ambulatory SBP of 135 to 170 mm Hg after medication washout underwent bipolar radiofrequency renal denervation or a sham procedure. The planned outcome was 8-week change in 24-h ambulatory SBP. Enrollment was terminated for apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Safety assessments included all-cause death, renal failure, severe hypotension or syncope, hypertensive crisis, and renal artery stenosis.
Results Baseline 24-h blood pressure was 148.3 ± 10.9/85.7 ± 9.1 mm Hg for the denervation group (n = 34, mean age 58.5 ± 10.1 years, 47% women) and 149.1 ± 7.2/86.4 ± 9.8 mm Hg for the control group (n = 17, mean age 58.2 ± 9.8 years, 24% women). At 8 weeks, mean 24-h SBP reductions for the renal denervation and control groups were −5.3 mm Hg (95% confidence interval [CI]: −8.8 to −1.8 mm Hg) and −8.5 mm Hg (95% CI: −13.3 to −3.8 mm Hg), respectively (difference 3.3 mm Hg; 95% CI: −2.8 to 9.3 mm Hg; p = 0.30). Antihypertensive medications could then be added. By 6 months, decreases in SBP were greater for the denervation group, yielding between-group differences of −7.2 mm Hg (95% CI: −15.2 to 0.8 mm Hg; p = 0.08), −9.7 mm Hg (95% CI: −17.7 to −1.7 mm Hg; p = 0.02), and −11.4 mm Hg (95% CI: −19.2 to −3.7 mm Hg; p < 0.01) for 24-h, daytime ambulatory, and office measurements, respectively. Through 12 months, 1 patient (renal denervation group) had a hypertensive urgency requiring immediate management, and 1 experienced progression of renal artery stenosis.
Conclusions Future studies of radiofrequency renal denervation must anticipate delayed treatment effects. (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension [REDUCE HTN: REINFORCE]; NCT02392351)
This study was funded by Boston Scientific. Dr. Weber is a consultant for Boston Scientific, Medtronic, Ablative Solutions, ReCor, Novartis, Johnson & Johnson, and Abbvie; and has conducted research for Medtronic, Boston Scientific, ReCor, Ablative Solutions, Novartis, Boehringer Ingelheim, Johnson & Johnson, and Astellas. Dr. Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical. Dr. Weir is a scientific adviser to Boston Scientific, Janssen, AstraZeneca, Boehringer-Ingelheim, Merck Sharp & Dohme, Relypsa, Vifor, AbbVie, and Akebia; and has received grants R01DK066013, U01DK106102, U01DK116095, R01HL127422, and R01HL132732 from the National Institutes of Health (NIH). Dr. Das is an adviser to Boston Scientific. Dr. Mendelsohn has received research grant support from Boston Scientific; and held equity in Vessix prior to its acquisition by Boston Scientific. Dr. Diaz-Cartelle is an employee of and owns stock in Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 25, 2019.
- Revision received September 24, 2019.
- Accepted October 15, 2019.
- 2020 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.