Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial

John D. Bisognano; George Bakris; Mitra K. Nadim; Juan Luis Munoz Sanchez; Abraham A. Kroon; Jill Schafer; Peter W. de Leeuw; Domenic A. Sica

doi:10.1016/j.jacc.2011.06.008

Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial

John D. Bisognano^*, George Bakris, Mitra K. Nadim, Juan Luis Munoz Sanchez, Abraham A. Kroon, Jill Schafer, Peter W. de Leeuw, Domenic A. Sica

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Objectives We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension. Background The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial. Methods This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2: 1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety. Results The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP

Original language	English
Pages (from-to)	765-773
Journal	Journal of the American College of Cardiology
Volume	58
Issue number	7
DOIs	https://doi.org/10.1016/j.jacc.2011.06.008
Publication status	Published - 9 Aug 2011

Keywords

baroreflex
medical device
resistant hypertension

Access to Document

10.1016/j.jacc.2011.06.008Licence: Free access - publisher

Cite this

Bisognano, J. D., Bakris, G., Nadim, M. K., Munoz Sanchez, J. L., Kroon, A. A., Schafer, J., de Leeuw, P. W., & Sica, D. A. (2011). Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial. Journal of the American College of Cardiology, 58(7), 765-773. https://doi.org/10.1016/j.jacc.2011.06.008

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title = "Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial",

abstract = "Objectives We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension. Background The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial. Methods This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2: 1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety. Results The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP ",

keywords = "baroreflex, medical device, resistant hypertension",

author = "Bisognano, {John D.} and George Bakris and Nadim, {Mitra K.} and {Munoz Sanchez}, {Juan Luis} and Kroon, {Abraham A.} and Jill Schafer and {de Leeuw}, {Peter W.} and Sica, {Domenic A.}",

year = "2011",

month = aug,

day = "9",

doi = "10.1016/j.jacc.2011.06.008",

language = "English",

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pages = "765--773",

journal = "Journal of the American College of Cardiology",

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Bisognano, JD, Bakris, G, Nadim, MK, Munoz Sanchez, JL, Kroon, AA, Schafer, J, de Leeuw, PW & Sica, DA 2011, 'Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial', Journal of the American College of Cardiology, vol. 58, no. 7, pp. 765-773. https://doi.org/10.1016/j.jacc.2011.06.008

Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial. / Bisognano, John D.; Bakris, George; Nadim, Mitra K. et al.
In: Journal of the American College of Cardiology, Vol. 58, No. 7, 09.08.2011, p. 765-773.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial

AU - Bisognano, John D.

AU - Bakris, George

AU - Nadim, Mitra K.

AU - Munoz Sanchez, Juan Luis

AU - Kroon, Abraham A.

AU - Schafer, Jill

AU - de Leeuw, Peter W.

AU - Sica, Domenic A.

PY - 2011/8/9

Y1 - 2011/8/9

N2 - Objectives We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension. Background The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial. Methods This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2: 1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety. Results The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP

AB - Objectives We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension. Background The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial. Methods This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2: 1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety. Results The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP

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