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Randomized Controlled Trial
. 2024 Feb 13;83(6):637-648.
doi: 10.1016/j.jacc.2023.11.032.

Randomized Trial of Effect of Bariatric Surgery on Blood Pressure After 5 Years

Carlos A Schiavon  1 , Alexandre B Cavalcanti  2 , Juliana D Oliveira  3 , Rachel H V Machado  2 , Eliana V Santucci  2 , Renato N Santos  2 , Julia S Oliveira  2 , Lucas P Damiani  2 , Débora Junqueira  2 , Helio Halpern  4 , Frederico de L J Monteiro  4 , Patricia M Noujaim  5 , Ricardo V Cohen  6 , Marcio G de Sousa  7 , Luiz A Bortolotto  8 , Otavio Berwanger  9 , Luciano F Drager  10
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Free article
Randomized Controlled Trial

Randomized Trial of Effect of Bariatric Surgery on Blood Pressure After 5 Years

Carlos A Schiavon et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Obesity represents a major obstacle for controlling hypertension, the leading risk factor for cardiovascular mortality.

Objectives: The purpose of this study was to determine the long-term effects of bariatric surgery on hypertension control and remission.

Methods: We conducted a randomized clinical trial with subjects with obesity grade 1 or 2 plus hypertension using at least 2 medications. We excluded subjects with previous cardiovascular events and poorly controlled type 2 diabetes. Subjects were assigned to Roux-en-Y gastric bypass (RYGB) combined with medical therapy (MT) or MT alone. We reassessed the original primary outcome (reduction of at least 30% of the total antihypertensive medications while maintaining blood pressure levels <140/90 mm Hg) at 5 years. The main analysis followed the intention-to-treat principle.

Results: A total of 100 subjects were included (76% women, age 43.8 ± 9.2 years, body mass index: 36.9 ± 2.7 kg/m2). At 5 years, body mass index was 36.40 kg/m2 (95% CI: 35.28-37.52 kg/m2) for MT and 28.01 kg/m2 (95% CI: 26.95-29.08 kg/m2) for RYGB (P < 0.001). Compared with MT, RYGB promoted a significantly higher rate of number of medications reduction (80.7% vs 13.7%; relative risk: 5.91; 95% CI: 2.58-13.52; P < 0.001) and the mean number of antihypertensive medications was 2.97 (95% CI: 2.33-3.60) for MT and 0.80 (95% CI: 0.51-1.09) for RYGB (P < 0.001). The rates of hypertension remission were 2.4% vs 46.9% (relative risk: 19.66; 95% CI: 2.74-141.09; P < 0.001). Sensitivity analysis considering only completed cases revealed consistent results. Interestingly, the rate of apparent resistant hypertension was lower after RYGB (0% vs 15.2%).

Conclusions: Bariatric surgery represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity. (GAstric bypass to Treat obEse Patients With steAdy hYpertension [GATEWAY]; NCT01784848).

Keywords: bariatric surgery; hypertension; obesity; remission; weight loss.

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Conflict of interest statement

Funding Support and Author Disclosures This work was supported by grant #100238 from Ethicon, represented in Brazil by Johnson and Johnson do Brasil. Dr Schiavon has received a research grant from Ethicon; and has received lecture fees from Ethicon and Medtronic. Dr Cohen has received a research grant paid to the Institution from Johnson and Johnson, Medtech, and Medtronic; has received honoraria for lectures, presentations, and Speakers Bureau from Johnson and Johnson, Medtech, Medtronic, Janssen Pharmaceuticals, Novo Nordisk, and Abbott; and is a member of the Scientific Advisory Board for Baritek and GI Dynamics. Dr Drager has received lecture fees from Ethicon. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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