Bariatric or metabolic surgery can significantly lower the risk of major cardiovascular events among patients with Type 2 diabetes and obesity, according to a new clinical study released at the European Society of Cardiology Congress in Paris.
The retrospective study followed 13,722 Type 2 diabetes patients who underwent bariatric surgery to lose weight or metabolic surgery to treat their diabetes, and 11,435 nonsurgical patients in a control group between 1998 and 2017. Thirty-one percent of the bariatric-metabolic surgery patients suffered a major cardiovascular event compared with 48% in the control group, according to the study results, which were published this week in The Journal of the American Medical Association.
The study’s six pre-specified outcomes — all-cause mortality, coronary disease events, cerebrovascular events, heart failure, atrial fibrillation, and nephropathy — were all lower in the surgery group, as were myocardial infarction and ischemic stroke.
The study’s authors concluded that the lower rate of such events after bariatric-metabolic surgery could be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities. All patients were treated in the Cleveland Clinic Health System.
In a related editorial, JAMA deputy editor Dr. Edward Livingston said that despite a few imbalances in the study — such as a slightly older average age in the control group — there is a clear frontrunner in treatment options for obese patients with diabetes.
“In 2019, for obese patients with diabetes, what is the best treatment option? The results from drug studies, although of relatively high quality, suggest limited effect on long-term macrovascular outcomes,” Livingston wrote. “In contrast, bariatric surgery appears to improve long-term outcomes, including mortality, but the quality of evidence is not as high. However, by inducing substantial weight loss, bariatric surgery not only treats diabetes but also improves hypertension, lipid levels, and sleep apnea; reduces osteoarthritis; and improves many other weight-related problems. When balancing the imperfections in the evidence for both medical and surgical treatment of diabetes, the many benefits associated with bariatric surgery-induced weight loss suggest that it should be the preferred treatment option for carefully selected, motivated patients who are obese and have diabetes and cannot lose weight by other means.”
Here are some other highlights from the conference:
MitraClip no better than med therapy
There is no added benefit of percutaneous repair of functional mitral regurgitation, according to a follow-up of a trial comparing the MitraClip from Abbott (NYSE:ABT) with optimal medical therapy.
The additional year of follow-up in the Mitra-FR trial showed that medical therapy resulted in 35% all-cause death, 32.1% cardiovascular death, 63.5% unplanned hospitalization and 68.6% major cardiovascular events, according to a report by Medscape. That’s compared to 33.9% all-cause death in patients treated with MitraClip, followed by 31.2% cardiovascular death, 58.7% unplanned hospitalization and 66.1% major cardiovascular events.
“In the group of patients defined by the inclusion criteria of Mitra-FR, the percutaneous correction of the MR does not improve the prognosis,” principal investigator Dr. Jean-François Obadia of Civil Hospices in Lyon, France, said at the ESC Congress.
Ablative Solutions touts renal denervation study results
Ablative Solutions said a post-market feasibility trial for its Peregrine system infusion catheter showed positive results in lowering blood pressure through alcohol-mediated renal denervation.
The study included 45 patients with systemic hypertension who were taking at least three anti-hypertensive medications. The Peregrine system delivered a neurolytic agent (dehydrated alcohol) into the space outside the renal arteries. A consistent blood pressure-lowering effect was sustained at 12 months, according to the Kalamazoo, Mich.-based company.
“The 12-month safety and performance in the postmarket study provides preliminary evidence that the renal denervation procedure using the Peregrine catheter and alcohol as a neurolytic agent may be safe and effective for lowering blood pressure in patients with poorly controlled hypertension on medications,” Horst Sievert of the CardioVascular Center in Frankfurt, Germany, said in a news release. “Alcohol-mediated renal denervation with the Peregrine system may be a compelling way to treat hypertension.”
“We are pleased by these promising results, which reaffirm the promise of the Ablative Solutions approach to blood pressure reduction,” added company president & CEO Kate Rumrill. “We are committed to robust clinical research to further substantiate the procedural, clinical, and health-economic benefits of the Peregrine catheter for the treatment of hypertension.”
Early ICD for PCI-treated STEMI saves lives
Data from a new trial suggest that early implantation of an implantable cardioverter defibrillator (ICD) in patients with ST-elevation myocardial infarction (STEMI) who have undergone primary percutaneous coronary intervention (PCI) significantly improves survival, compared to medical therapy.
In the trial, 266 high-risk STEMI patients who had undergone PCI were randomized to receive an ICD or medical therapy no more than 40 days after a heart attack. The results showed that early ICD was associated with a 48% drop in all-cause mortality, compared to medical therapy.
Dr. Arif Elvan, a cardiologist at Isala Klinieken, Zwolle, the Netherlands, told theheart.org/Medscape Cardiology that ICD, while proven successful in this trial, should be carefully administered following STEMI that has been treated with PCI.
“People die from heart failure or other complications, but if you do it after 30 days it’s absolutely feasible,” Elvan said.
CABG tops PCI in three-vessel disease survival rate
Patients who had three-vessel coronary artery disease (CAD) and needed de novo revascularization had a better 10-year survival rate following coronary artery bypass grafting (CABG) compared with similar patients who underwent percutaneous coronary intervention (PCI), according to a new study.
Of the 1,800 patients studied across 85 hospitals in Europe and North America, 903 had PCI and 897 underwent CABG. Sixty percent of patients had three-vessel disease and the other 40% had left main CAD. In the three-vessel disease group, 28% had died in the 10 years following PCI versus 21% who had CABG. In patients with left main CAD, 26% died following PCI compared with 28% who underwent CABG.
Dr. David Taggart of the University of Oxford and Dr. Domenico Pagano of the University of Birmingham, both in the UK, vouched for CABG in an editorial published in The Lancet.
“With longer-term outcome data now available, there is, in the absence of medical contraindications or patient preference, a clear mandate to expand the role of CABG and to adopt a more cautious indication for PCI,” Taggart and Pagano wrote.