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GATEWAY trial

Obesity: Gastric bypass is an effective strategy for BP control

At 12 months, 25 (51%) of patients randomised to gastric bypass, and none in the control group, remained with controlled blood pressure without medications

Gastric bypass is an effective strategy for blood pressure (BP) control in a broad population of patients with obesity and hypertension, according to the Gastric Bypass to Treat Obese Patients With Steady Hypertension (GATEWAY). The GATEWAY trial results revealed that gastric bypass surgery - along with medical therapy - results in significantly better BP control compared with medical therapy alone among middle-aged obese patients with BP. The outcomes, ‘Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension)’, were published in Circulation and simultaneously presented at the American Heart Association's Scientific Sessions 2017.

Carlos Schiavona (Credit: saudemetabolica.com.br)

"This study suggests that cardiologists treating obese patients with hypertension, mainly those with severe obesity and using more than two drugs, can consider referring these patients for bariatric surgery, which is consistent with the American Heart Association, American College of Cardiology and The Obesity Society Clinical Practice Guidelines," said lead author, Dr Carlos Aurelio Schiavona from the Hospital do Coracão (HCor), São Paulo, Brazil. "Fewer or no medications means better compliance and weight loss with an improved metabolic and inflammatory profile combine to reduce the risk of major cardiovascular events for these patients."

The researchers recognised that recent studies on bariatric surgery have focused on metabolic and diabetes mellitus resolution.  However, there are few randomised trials assessing the impact of bariatric surgery in patients with obesity and hypertension. Therefore, they established GATEWAY study to assess the safety and efficacy of bariatric surgery in improving BP control among obese patients with hypertension (HTN).

In this randomised, single-centre, non-blinded trial, 100 patients with hypertension (using at least two medications at maximum doses or more than two at moderate doses) and with BM30.0-39.9 were randomised to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of at least 30% of the total antihypertensive medications, while maintaining systolic and diastolic blood pressure lower than 140mmHg and 90mmHg, respectively, at 12 months.

Outcomes

In total, 70% of the patients were female, the mean age was 43.8±9.2, mean BMI36.9±2.7) and 96% of patients completed follow-up. The outcomes showed a reduction on the total antihypertensive medications of at least 30% while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%), as compared with six of 47 patients (12.8%) from the control group (rate ratio, 6.6; 95% confidence interval, 3.1 to 14.0; p<0.001, Figure 1).

Figure 1: >30%reduction in the number of anti-hypertensive medications while maintaining controlled blood pressure (%)

At 12 months, 25 (51%) of patients randomised to gastric bypass, and none in the control group, remained with controlled blood pressure without medications. A post-hoc analysis for the primary end point considering the SPRINT target reached consistent results (rate ratio, 3.8; 95% CI, 1.4 to 10.6; p=0.005). A total of 11 patients (22.4%) from gastric bypass group and none in the control group were able to achieve SPRINT levels without anti-hypertensives.

In addition, waist circumference, BMI, fasting plasma glucose, glycated haemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group.

"The GATEWAY Study adds to the body of evidence that shows surgery is the most effective and durable treatment for obesity, and its benefits extend beyond weight loss with improvement or resolution of related health conditions including hypertension and type 2 diabetes," said Dr Elliott Fegelman, Therapeutic Area Lead for Metabolics at Johnson & Johnson Innovation. This investigator-initiated study was funded with a grant from Ethicon.

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