Shorter History of Hypertension as a Predictor of Hypertension Remission after 3-years of Bariatric Surgery: Data from the GATEWAY Trial.

BACKGROUND: Previous evidence explored predictors of hypertension (HTN) remission after bariatric but data are limited to observational studies and lack of ambulatory blood pressure monitoring (ABPM). This study was aimed to evaluate the rate of HTN remission after bariatric surgery using ABPM and to define predictors of mid-term HTN remission. METHODS: We included patients enrolled in the surgical arm of the GATEWAY randomized trial. HTN remission was defined as controlled blood pressure (< 130 × 80 mmHg) evaluated by 24-h ABPM while no need of anti-hypertensive medications after 36 months. A multivariable logistic regression model was used to assess the predictors of HTN remission after 36 months. RESULTS: 46 patients submitted Roux-en-Y gastric bypass (RYGB). HTN remission occurred in 39% (n = 14 out of 36 patients with complete data at 36 months). Patients with HTN remission had shorter HTN history than no remission group (5.9 ± 5.5 vs. 12.5 ± 8.1 years; p = 0.01). The baseline insulin levels were lower in patients who presented HTN remission, although not statistically significant (OR: 0.90; CI 95%: 0.80-0.99; p = 0.07). In the multivariate analysis, the HTN history (years) was the only independent predictor of HTN remission (OR: 0.85; 95% CI: 0.70-0.97; p = 0.04). Therefore, for each additional year of HTN history, the chance of HTN remission decreases by approximately 15% after RYGB. CONCLUSION: After 3 years of RYGB, HTN remission defined by ABPM was common and independently associated with a shorter HTN history. These data underscore the need of early effective approach of obesity aiming greater impact in its comorbidities.

Three-year effects of bariatric surgery on obstructive sleep apnea in patients with obesity grade 1 and 2: a sub-analysis of the GATEWAY trial.

BACKGROUND: Most of the evidence on bariatric surgery on obstructive sleep apnea (OSA) is based on observational studies and/or short-term follow-up in patients with obesity grade 3. SUBJECTS/METHODS: This randomized study compared the effects of roux-en-Y gastric bypass (RYGB) or usual care (UC) on OSA severity in patients with obesity grade 1-2. Mild, moderate, and severe OSA was defined by the apnea-hypopnoea index (AHI): 5-14.9; 15-29.9, and ≥30 events/h, respectively. OSA remission was defined by converting any form of OSA into normal AHI (<5 events/h). RESULTS: After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/m2, respectively. The AHI increased by 5 (-4.2; 12.7) in the UC group while reduced in the RYGB group to -13.2 (-22.7; -7) events/h. UC significantly increase the frequency of moderate OSA (from 15.4 to 46.2%). In contrast, RYGB had a huge impact on reaching no OSA status (from 4.2 to 70.8%) in parallel to a decrease of moderate (from 41.7 to 8.3%) and severe OSA (from 20.8 to 0%). CONCLUSIONS: RYGB is an attractive strategy for mid-term OSA remission or decrease moderate-to-severe forms of OSA in patients with obesity grade 1-2.

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

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.

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

BACKGROUND: Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain. OBJECTIVE: To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone. DESIGN: Randomized clinical trial. (ClinicalTrials.gov: NCT01784848). SETTING: Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil. PARTICIPANTS: Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m2 were randomly assigned (1:1 ratio). INTERVENTION: RYGB plus MT or MT alone. MEASUREMENTS: The primary outcome was at least a 30% reduction in total number of antihypertensive medications while maintaining BP less than 140/90 mm Hg. Key secondary outcomes were number of antihypertensive medications, hypertension remission, and BP control according to current guidelines (<130/80 mm Hg). RESULTS: Among 100 patients (76% female; mean BMI, 36.9 kg/m2 [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up. At 3 years, the primary outcome occurred in 73% of patients from the RYGB group compared with 11% of patients from the MT group (relative risk, 6.52 [95% CI, 2.50 to 17.03]; P < 0.001). Of the randomly assigned participants, 35% and 31% from the RYGB group and 2% and 0% from the MT group achieved BP less than 140/90 mm Hg and less than 130/80 mm Hg without medications, respectively. Median (interquartile range) number of medications in the RYGB and MT groups at 3 years was 1 (0 to 2) and 3 (2.8 to 4), respectively (P < 0.001). Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively. In the RYGB group, 13 patients developed hypovitaminosis B12 and 2 patients required reoperation. LIMITATION: Single-center, nonblinded trial. CONCLUSION: RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity. PRIMARY FUNDING SOURCE: Ethicon, represented in Brazil by Johnson & Johnson do Brasil.