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Metabolic surgery and MACE

Surgery associated with lower risk of death and heart complications

Over an eight-year period, patients undergoing metabolic surgery were 40 percent less likely to experience one of these events than those receiving usual medical care
Patients in the surgical group were 41 percent less likely to die from any cause

Researchers from the Cleveland Clinic have found that bariatric and metabolic surgery performed in patients with type 2 diabetes and obesity is associated with a lower risk of death and major adverse cardiovascular events than usual medical care. These patients also lost more weight, had better diabetes control, and used fewer medications for treatment of their diabetes and cardiovascular disease than those undergoing usual medical care.

The observational study, ‘Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity’, published in JAMA, wanted to know whether there is association between metabolic surgery and major adverse cardiovascular events (all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation) in patients with type 2 diabetes and obesity. The results have been presented as a late-breaking study at the European Society of Cardiology Congress.

Ali Aminian

"The striking results that we saw after metabolic surgery may be related to the patients' substantial and sustained weight loss," said Dr Ali Aminian, a bariatric surgeon at Cleveland Clinic and lead author of the study. "However, there is a growing body of evidence to suggest that there are beneficial metabolic and hormonal changes after these surgical procedures that are independent of weight loss."

The researchers included 13,722 patients (including 2,287 patients who underwent metabolic surgery and 11,435 matched controls). Patients underwent one of four types of bariatric and metabolic surgery: gastric bypass (n=1,443 [63%]), sleeve gastrectomy (n=730 [32%]), adjustable gastric banding (n=109 [5%]) and duodenal switch (n=5). In the surgical group, 1,713 patients (75%) had a BMI>40, 465 patients (20%) had a BMI35-39.9 and 109 patients (5%) had a BMI30-34.9.

The primary endpoint of the study was the occurrence of death or one of five major complications associated with obesity and diabetes: coronary artery events, cerebrovascular events, heart failure, atrial fibrillation, and kidney disease.

Outcomes

After matching, the distribution of 37 baseline covariates was balanced between the metabolic surgery group and usual care group for most characteristics. However, patients in the surgery group had higher body weight (126.5 vs 120.2kg), higher BMI (45.1 vs 42.6) and higher rates of dyslipidaemia (74% vs 65%) and hypertension (85% vs 75%). The control group was older (54.8 vs 52.5 years) and had higher rates of black race (25% vs 19%), current smoking (14% vs 7%, and aspirin use (40% vs 32%). The median follow-up time for the entire cohort was 3.9 years, including 4.0 years for nonsurgical patients and 3.3 years for surgical patients.

At the end of the study period, 385 patients in the surgical group and 3,243 patients in the nonsurgical group experienced a primary composite end point. The cumulative incidence of primary end point at eight-year follow-up was 30.8% in the surgical group and 47.7% in the nonsurgical group (p<0.001). there was no heterogeneity in the association of metabolic surgery with the primary outcome based on sex, age, BMI, HbA1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas or lipid-lowering medications.

At the end of the study, three-component MACE occurred in 194 patients in the surgical group and 1,765 patients in the nonsurgical group. Metabolic surgery was associated with a significantly lower cumulative incidence of three-component MACE at eight years compared with usual care (17.0% vs 27.6%.

During follow-up, 112 patients in the metabolic surgery group and 1,111 patients in the nonsurgical group died. Metabolic surgery was also associated with significantly lower incidence of the other five individual end points, including coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation.

"Cardiovascular complications from obesity and diabetes can be devastating,” said Dr Steven Nissen, Chief Academic Officer of the Heart & Vascular Institute at Cleveland Clinic and the study's senior author. “Now that we've seen these remarkable results, a well-designed randomised controlled trial is needed to definitively determine whether metabolic surgery can reduce the incidence of major heart problems in patients with type 2 diabetes and obesity.”

The mean body weight at eight years was reduced by 29.1 kg in the surgery group and 8.7 kg (in the nonsurgical control group. Metabolic surgery was also associated with a significant reduction in HbA1c level (mean difference in changes from baseline at eight years between groups, 1.1%; p<0.001).

Use of noninsulin diabetes medications, insulin, renin-angiotensin system blockers, other antihypertensive medications, lipid-lowering therapies, and aspirin were also significantly lower after metabolic surgery, compared with usual care.

“Among patients with type 2 diabetes and obesity, metabolic surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident MACE,” the authors concluded. “The findings from this observational study must be confirmed in randomised clinical trials.”

To access this paper, please click here

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