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Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease.
Int J Cardiol. 2018 Sep 01; 266:187-192.IJ

Abstract

BACKGROUND

In a randomized trial, baroreflex activation therapy (BAT) improved exercise capacity, quality of life and NT-proBNP in patients with heart failure with reduced ejection fraction (HFrEF). In view of different mechanisms underlying HFrEF, we performed a post-hoc subgroup analysis of efficacy and safety of BAT in patients with and without coronary artery disease (CAD).

METHODS AND RESULTS

Patients with left ventricular ejection fraction <35% and NYHA Class III were randomized 1:1 to guideline-directed medical and device therapy alone or plus BAT. Patients with a history of CAD, prior myocardial infarction or coronary artery bypass graft were assigned to the CAD group with all others assigned to the no-CAD group. Of 71 BAT treated patients, 52 had CAD and 19 had no CAD. In the control group, 49 of 69 patients had CAD and 20 had no CAD. The system- or procedure-related major adverse neurological or cardiovascular event rate was 3.8% in the CAD group vs. 0% in the no-CAD group (p = 1.0). In the whole cohort, NYHA Class, Minnesota Living with Heart Failure score, 6-minute hall walk distance and NTproBNP were improved in BAT treated patients compared with controls. Statistical analyses revealed no interaction between the presence of CAD and effect of BAT (all p > 0.05).

CONCLUSION

No major differences were found in BAT efficacy or safety between patients with and without CAD, indicating that BAT improves exercise capacity, quality of life and NTproBNP in patients with ischemic and non-ischemic cardiomyopathy. CLINICALTRIALS.

GOV IDENTIFIER

NCT01471860 and NCT01720160.

Authors+Show Affiliations

Department of Internal Medicine III, University Hospital of Cologne, Cologne, Germany. Electronic address: marcel.halbach@uk-koeln.de.Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.Department of Cardiology, Immanuel Heart Center Bernau - Medical School Brandenburg, Bernau, Germany.Montreal Heart Institute, University of Montréal, Montreal, Quebec, Canada.Department of Cardiology A, University Hospital, Lille, France.Division of Cardiology, University of Mississippi Medical Center, Jackson, MS, USA.Department of Internal Medicine III, University Hospital of Cologne, Cologne, Germany.Department of Statistics, NAMSA, Inc., Minneapolis, MN, USA.Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.Department of Electrophysiology, Arizona Heart Hospital, Phoenix, AZ, USA.Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany.Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.Department of Research, CVRx, Inc., Minneapolis, MN, USA.Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA.Department of Medicine, Asklepios Klinik Altona, Hamburg, Germany.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29705650

Citation

Halbach, Marcel, et al. "Baroreflex Activation Therapy for the Treatment of Heart Failure With Reduced Ejection Fraction in Patients With and Without Coronary Artery Disease." International Journal of Cardiology, vol. 266, 2018, pp. 187-192.
Halbach M, Abraham WT, Butter C, et al. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018;266:187-192.
Halbach, M., Abraham, W. T., Butter, C., Ducharme, A., Klug, D., Little, W. C., Reuter, H., Schafer, J. E., Senni, M., Swarup, V., Wachter, R., Weaver, F. A., Wilks, S. J., Zile, M. R., & Müller-Ehmsen, J. (2018). Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. International Journal of Cardiology, 266, 187-192. https://doi.org/10.1016/j.ijcard.2018.04.075
Halbach M, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With Reduced Ejection Fraction in Patients With and Without Coronary Artery Disease. Int J Cardiol. 2018 Sep 1;266:187-192. PubMed PMID: 29705650.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. AU - Halbach,Marcel, AU - Abraham,William T, AU - Butter,Christian, AU - Ducharme,Anique, AU - Klug,Didier, AU - Little,William C, AU - Reuter,Hannes, AU - Schafer,Jill E, AU - Senni,Michele, AU - Swarup,Vijay, AU - Wachter,Rolf, AU - Weaver,Fred A, AU - Wilks,Seth J, AU - Zile,Michael R, AU - Müller-Ehmsen,Jochen, Y1 - 2018/04/21/ PY - 2018/02/27/received PY - 2018/04/01/revised PY - 2018/04/17/accepted PY - 2018/5/1/pubmed PY - 2019/1/27/medline PY - 2018/4/30/entrez KW - Baroreflex activation therapy KW - Coronary artery disease KW - Device KW - Heart failure SP - 187 EP - 192 JF - International journal of cardiology JO - Int. J. Cardiol. VL - 266 N2 - BACKGROUND: In a randomized trial, baroreflex activation therapy (BAT) improved exercise capacity, quality of life and NT-proBNP in patients with heart failure with reduced ejection fraction (HFrEF). In view of different mechanisms underlying HFrEF, we performed a post-hoc subgroup analysis of efficacy and safety of BAT in patients with and without coronary artery disease (CAD). METHODS AND RESULTS: Patients with left ventricular ejection fraction <35% and NYHA Class III were randomized 1:1 to guideline-directed medical and device therapy alone or plus BAT. Patients with a history of CAD, prior myocardial infarction or coronary artery bypass graft were assigned to the CAD group with all others assigned to the no-CAD group. Of 71 BAT treated patients, 52 had CAD and 19 had no CAD. In the control group, 49 of 69 patients had CAD and 20 had no CAD. The system- or procedure-related major adverse neurological or cardiovascular event rate was 3.8% in the CAD group vs. 0% in the no-CAD group (p = 1.0). In the whole cohort, NYHA Class, Minnesota Living with Heart Failure score, 6-minute hall walk distance and NTproBNP were improved in BAT treated patients compared with controls. Statistical analyses revealed no interaction between the presence of CAD and effect of BAT (all p > 0.05). CONCLUSION: No major differences were found in BAT efficacy or safety between patients with and without CAD, indicating that BAT improves exercise capacity, quality of life and NTproBNP in patients with ischemic and non-ischemic cardiomyopathy. CLINICALTRIALS. GOV IDENTIFIER: NCT01471860 and NCT01720160. SN - 1874-1754 UR - https://www.unboundmedicine.com/medline/citation/29705650/Baroreflex_activation_therapy_for_the_treatment_of_heart_failure_with_reduced_ejection_fraction_in_patients_with_and_without_coronary_artery_disease_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0167-5273(18)31351-2 DB - PRIME DP - Unbound Medicine ER -