Dr. Mikhail Kosiborod is a cardiologist, Vice President of Research at Saint Luke’s Health System, Director of Cardiometabolic Research and the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute, and Professor of Medicine at the University of Missouri-Kansas City. He serves as one of George Clinical’s scientific leaders. Dr. Maria Ali, CMO, George Clinical, talked with him at the recent AHA Scientific Sessions to get his thoughts on the most important emerging stories in cardiovascular care.
What were your main takeaways from the recent ESC and EASD conferences in Europe?
“By far the biggest story is the results from clinical trials of the SGLT2 inhibitor class of drugs originally developed for treating diabetes and lowering glucose. Data being generated from both the DAPA HF and the DEFINE HF trials show that this new class of agents appear to trigger mechanisms that have very little to do with the glucose lowering and extend to being highly effective in improving important heart failure outcomes. The results are the same whether a patient has diabetes or not – in the DAPA trial, 55% of the patients did NOT have diabetes.”
“We began to get a glimpse of this back in 2015 with the Empagliflozin trials where cardiovascular benefits were unexpected but already in evidence. With the DAPA trial with dapagliflozin you have great numbers of patients across the globe with reduced risk of cardiovascular death or hospitalization for HF and also improved health status as measured by KCCQ. At eight months there were not only fewer patients with deterioration of their symptom burden, but also more patients with improvements in their symptoms. What is meaningful new information from DEFINE is the time period in which you see compelling improvements in endpoints, which are already evident as early as 12 weeks, as well as the number of patients you need to treat to see these benefits. There are three goals you strive for in management of heart failure – reduce very favorable safety profiles. It’s really a full house – the results couldn’t be better.”
What do you see as the highlights of the AHA Scientific Sessions?
“DAPA-HF investigators presented data that showed dapagliflozin improved symptoms and reduced the risk of cardiovascular death and worsening heart failure events by 26% over a median follow-up of 18.2 months across all age groups of patients with HF with reduced ejection fraction (HFrEF).”
“The PARAGON-HF investigators presented data showing that compared to valsartan, sacubitril/valsartan reduced the risk of HF hospitalization more in women than in men. Unfortunately, for patients with reduced injection fraction (HFpEF) PARAGON just missed the primary endpoint and came up just short of the total number of events in a statistically significant way. However, there were signals, at least in some subpopulation patients, that the treatment may be effective. This is a need that is going to require more research.”
“The COMPLETE trial gave us data that is going to hopefully help solidify guidelines and to prevent second events and reduce mortality and improve patient experience and outcomes for patients after a myocardial infarction. COMPLETE demonstrated that complete revascularization is superior to a staged approach for both the primary and secondary endpoints of CV death and also new MIs and ischemic revascularization.”
“And lastly, another important story helped to answer a question that has dogged clinicians for years concerning conservative vs. invasive initial treatment strategies in terms of their ability to provide symptom relief from angina and quality of life improvements in patients that have stable ischemic heart disease (SIHD) and demonstrable ischemia. It has now been definitively answered that there is no evidence of a lower risk for invasive vs. conservative management strategies for the primary endpoint, specifically the risk for cardiovascular death or heart attack or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest. However, patients symptomatic to start that got heart procedures, over the years, had fewer symptoms and reported a higher quality of life and feeling better. This question that has dogged clinicians for years has now been definitively answered by this large, ambitious trial and will most likely lead to fewer invasive procedures for stable patients in the future.”
Read more about the scientific leadership team at George Clinical.
Meet the cardiovascular scientific leadership team at George Clinical.