Bariatric surgery should be considered for obese patients with fibrotic nonalcoholic steatohepatitis, a major study suggests
Published in JAMA, the findings of the Surgical Procedures and Long-term Effectiveness in NASH Disease and Obesity Risk (SPLENDOR) study show bariatric surgery was associated with an 88% reduction in major adverse liver-related outcomes (MALO) and a 70% reduction in major adverse cardiovascular events (MACE) in adults with obesity and NASH fibrosis stage 1 to 3 compared to a non-surgery control group.
Patients in the bariatric surgery group, also had significant reductions in body weight and in HbA1c levels over the long term.
The retrospective cohort study analysed outcomes for 1158 patients with obesity (BMI ≥30) and biopsy-proven NASH fibrosis stage 1 to 3, excluding those with alcohol-related liver disease.
Outcomes were compared for a surgical group of 650 adults with liver biopsy at the time of bariatric surgery (Roux-en-Y gastric bypass, 83% or sleeve gastrectomy, 17%) and a control group of 508 patients who did not undergo surgery and received usual care for obesity and NASH.
The primary outcomes were MALO, a composite end point of progression to histologic cirrhosis, clinical (decompensated) cirrhosis, development of hepatocellular carcinoma (HCC), liver transplant, or liver-related mortality. Another primary outcome was MACE, a composite end point of coronary artery events, cerebrovascular events, heart failure, or cardiovascular-related mortality.
Over ten years of follow up, the cumulative incidence of MALO was 2.3% in the surgical group compared with 9.6% in the nonsurgical group, with an adjusted absolute risk difference of 12.4%; adjusted hazard ratio (aHR), 0.12.
For MACE the cumulative incidence at 10 years was 8.5% in the surgical group compared with 15.7% in the nonsurgical control group; while the adjusted absolute risk difference was 13.9% (aHR, 0.30).
The study authors, from the Cleveland Clinic, Ohio, said the findings showed that bariatric surgery was an effective option for obese patients with fibrotic NASH, for whom there are currently no approved rug treatments
“The striking findings of this study provide strong evidence that bariatric surgery should be considered as an effective therapeutic option for patients with advanced fatty liver and obesity,” said lead investigator Dr Ali Aminian, director of Cleveland Clinic’s Bariatric & Metabolic Institute .
The study’s senior investigator, Professor Steven Nissen, Chief Academic Officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic, noted that obesity is the main pathophysiologic driver of NASH, and bariatric surgery is the most effective available therapy for obesity.
“This is the first study in the medical field reporting a treatment modality that is associated with decreased risk of major adverse events in patients with biopsy-proven NASH,” he said
“The SPLENDOR study shows that in patients with obesity and NASH, substantial and sustained weight loss achieved with bariatric surgery can simultaneously protect the heart and decrease the risk of progression to end-stage liver disease,” he added.
An accompanying commentary in JAMA cautioned that consideration of the potential benefits of bariatric surgery in patients with NASH must be balanced against surgical risk, noting that almost 10% of surgery group developed major adverse events within 30 days after surgery, and 4 patients (0.6%) died from surgical complications within 1 year after surgery.
“More data on immediate complication rates and long-term outcomes in patients with NASH are needed so that clinicians have informed data on the benefits and risks of bariatric surgery,” it said.
Nevertheless, it concluded that “the findings from this study suggest that for patients with appropriate indications for bariatric surgery (BMI ≥40 or ≥35 with obesity-related conditions) and NASH with fibrosis stage 1 to 3, clinicians should consider referral of those patients for bariatric surgery.”