An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems

Rolf Wachter; Marcel Halbach; George L Bakris; John D Bisognano; Hermann Haller; Joachim Beige; Abraham A Kroon; Mitra K Nadim; Eric G Lovett; Jill E Schafer; Peter W de Leeuw

doi:10.1016/j.jash.2016.12.003

An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems

J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.

Authors

Affiliations

¹ Clinic for Cardiology and Pneumology, German Center for Cardiovascular Research (DZHK), University of Göttingen, Göttingen, Germany. Electronic address: [email protected].
² Department of Internal Medicine III, Heart Center, University of Cologne, Cologne, Germany.
³ Department of Medicine, ASH Comprehensive Hypertension Center, Section of Endocrinology, Diabetes and Metabolism, University of Chicago, Chicago, IL, USA.
⁴ Division of Cardiology, Department of Internal Medicine, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, USA.
⁵ Department of Nephrology and Hypertension, Medizinische Hochschule Hannover, Hannover, Germany.
⁶ Department of Nephrology and KfH Renal Unit, Hospital St. Georg, Leipzig, Germany.
⁷ Department of Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, The Netherlands.
⁸ Division of Nephrology and Hypertension, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
⁹ Department of Research, CVRx, Inc., Minneapolis, MN, USA.
¹⁰ Department of Statistics, NAMSA, Inc., Minneapolis, MN, USA.

PMID: 28065708
DOI: 10.1016/j.jash.2016.12.003

Abstract

Baroreflex activation therapy (BAT) is a device-based therapy for patients with treatment-resistant hypertension. In a randomized, controlled trial, the first-generation system significantly reduced blood pressure (BP) versus sham. Although an open-label validation study of the second-generation system demonstrated similar BP reductions, controlled data are not presently available. Therefore, this investigation compares results of first- and second-generation BAT systems. Two cohorts of first-generation BAT system patients were generated with propensity matching to compare against the validation group of 30 second-generation subjects. The first cohort was drawn from the first-generation randomized trial sham group and the second cohort from the active therapy group. Safety and efficacy were compared for the second-generation group relative to the first generation. At 6 months, second-generation BAT outperformed first-generation sham systolic BP reduction by 20 ± 28 mm Hg (mean ± standard deviation, P = .008), while BP reduction in first- and second-generation active groups was similar. At 12 months, efficacy was comparable between all three groups after the sham group had received 6 months of therapy; 47% of second-generation patients achieved goal systolic BP of 140 mm Hg or less after 12 months, comparable to 50% of patients at goal in the first-generation group (P > .999). Implant procedure time, system/procedural safety, and pulse generator longevity improved with the second-generation system. Propensity-matched cohort analysis of the first- and second-generation BAT systems suggests similar therapeutic benefit and superior BP reduction of the second-generation system relative to sham control. Implantation procedure duration and perioperative safety were improved with the second-generation device. These findings should be validated in a prospective randomized trial.

Trial registration: ClinicalTrials.gov NCT00442286 NCT01471834.

Keywords: Autonomic nervous system; baroreflex; resistant hypertension; sham control.

Publication types

Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Antihypertensive Agents / therapeutic use
Baroreflex / physiology
Blood Pressure Determination
Coronary Vasospasm / therapy*
Electric Stimulation Therapy / adverse effects
Electric Stimulation Therapy / instrumentation*
Electric Stimulation Therapy / methods*
Electrodes, Implanted*
Equipment Design
Female
Humans
Hypertension / therapy*
Male
Middle Aged
Operative Time
Propensity Score
Randomized Controlled Trials as Topic
Retrospective Studies
Treatment Outcome

Substances

Antihypertensive Agents

Supplementary concepts

Hypertension Resistant to Conventional Therapy

Associated data

ClinicalTrials.gov/NCT00442286
ClinicalTrials.gov/NCT01471834