Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension: A Randomized Clinical Trial

ABSTRACT

Hypertension is a leading cause of cardiovascular mortality (1). Its unfavorable impact is potentially explained by several factors, including the asymptomatic nature of this condition, poor medication adherence, and high burden of comorbid conditions, including obesity (1, 2). Hypertension occurs mostly in persons with excess weight and is often poorly controlled in patients with obesity (3, 4), and pharmacologic treatment of obesity has modest impact on blood pressure (BP) reduction (5). Bariatric surgery is the most effective method to treat obesity (6 ­ 8). Although recent research efforts have focused on metabolic improvement and diabetes resolution (9 ­12), growing interest has been devoted to evaluating the effects of this surgery on hypertension (13­15). The GATEWAY (Gastric Bypass to Treat Obese Patients With Steady Hypertension) trial focused on hypertension and included patients with mild obesity (body mass index [BMI], 30 to 34.9 kg/m2 ) and those with a BMI greater than 35 kg/m2 per current guidelines. The 1-year results showed that patients with coexisting obesity and hypertension were able to reduce or completely discontinue their antihypertensive medications after surgery, while maintaining a controlled BP and a similar 24-hour BP profile (16, 17). However, midterm effects of bariatric surgery on office and 24-hour BP measurements in a broad population of patients with obesity and hypertension remain uncertain. Here, we present the 3-year results from the GATEWAY trial. METHODS The GATEWAY trial is a randomized, nonblinded, single-center, investigator-initiated clinical trial performed at Heart Hospital in Sa˜ o Paulo, Brazil. Study design (18) and 1-year results (16) were previously pub lished; the full protocol, approved by the Research Ethics Board at the Heart Hospital (HCor), and the statistical analysis plan are available in Supplements 1 and 2 (available at Annals.org). The follow-up period for the primary end point was 12 months, but we prespecified that all patients would be scheduled for a 3-year and 5-year extension study. Here, we present the 3-year outcomes.