Stephen Greene, MD, is an associate professor of medicine at Duke University School of Medicine and cardiologist at the Duke Clinical Research Institute in Durham, NC. Greene is a member of Practical Cardiology's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Stephen Greene, MD

Javed Butler, MD, joins the podcast to discuss EMPACT-MI at ACC.24.

Don't Miss a Beat: EMPACT-MI at ACC.24, with Javed Butler, MD

07:00 - Inclusion Criteria and Patient Characteristics

15:27 - Implications for Post-MI Patient Population

23:39 - Kidney Outcomes in Post-MI Patient Population

American College of Cardiology 2024 (ACC.24) Annual Scientific Sessions

, few planned data releases garnered as much attention and anticipation as the EMPACT-MI trial offered the prospect of further insight into the effects of SGLT2 inhibitors among a patient population with 

An event-driven, double-blind, randomized, placebo-controlled trial, EMPACT-MI randomized 6522 patients in a 1:1 ratio to empagliflozin or placebo in addition to standard of care within 14 days of admission, with 3260 randomized to empagliflozin and 3262 randomized to placebo. The trial’s primary endpoint was a composite of first hospitalization for 

 and all-cause mortality assessed in a time-to-first-event analysis.

Results of the trial presented by lead investigator Javed Butler, MD, president of the Baylor Scott and White Research Institute in Dallas, distinguished professor of medicine at the University of Mississippi, indicate use of empagliflozin did not provide a significant benefit in reducing overall heart failure hospitalizations or death from any cause (Hazard Ratio [HR], 0.90; 95% Confidence Interval [CI], 0.76 to 1.06; 

= .21). Additional analysis indicated the trend toward benefit observed in the trial was driven by a statistically significant reduction in heart failure hospitalization (HR, 0.77; 95% CI, 0.60 to 0.98).

Butler joins hosts Muthiah Vaduganathan, MD, MPH, co-director of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, and Steve Greene, MD, advanced heart failure specialist at the Duke Clinical Research Institute, for a breakdown of the trial, including primary results, secondary findings, how data from DAPA-MI and EMPACT-MI complement each other, and what is next for the SGLT2 inhibitor class.

Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others.

Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.

Relevant disclosures for Butler include AstraZeneca, Bayer Healthcare, Boehringer Ingelheim Pharmaceuticals, Eli Lilly and Company, and 

Butler J, Anker SD, Bhatt DL, et al. Empagliflozin After Acute Myocardial Infarction: Results Of The EMPACT-MI Trial. Presented at: American College of Cardiology (ACC.24) Annual Scientific Session. April 6 – 8, 2024. Atlanta, GA.

James S, Erlinge D, Storey RF, et al. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. 

. 2024;3(2):EVIDoa2300286. doi:10.1056/EVIDoa2300286

Podcasts

In this ACC.24 episode of Don't Miss a Beat, hosts are joined by Javed Butler, MD, for a breakdown of the EMPACT-MI trial. 

Muthiah Vaduganathan, MD, MPH, and STeve Greene, MD, discuss top data from AHA 2023, including SELECT and DAPA-MI

Don't Miss a Beat at AHA 2023

The final flagship meeting on the calendar each year in the world of cardiology, the 

American Heart Association Scientific Sessions

 serves as a premier showcase for advancements and breakthroughs in cardiovascular medicine. The AHA Scientific Sessions 2023 continued this tradition, with the meeting serving as a platform for what many consider could be remembered as one of the most important trials, in regard to impact on public health, in decades.

, hosts Muthiah Vaduganathan, MD, MPH, codirector of the Center for Implementation Science at Brigham and Women’s Hospital, and Steve Greene, MD, advanced heart failure specialist at the Duke Clinical Research Institute, sit down between sessions at AHA 2023 to discuss the landmark SELECT trial and its implications for care moving forward.

The largest and longest trial of semaglutide in adults without type 1 or type 2 diabetes, the trial enrolled patients in a 1:1 ratio to either semaglutide 2.4 mg or placebo therapy. The trial’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in a time-to-first-event analysis. At the end of the trial, the mean change in body weight was –9.39% with semaglutide and –0.88% with placebo (estimated treatment difference, –8.51 percentage points; 95% CI, –8.75 to –8.27).

Results of the trial 17,000-patient trial suggested a primary event occurred among 6.5% of the semaglutide group and 8.0% of the placebo group (HR, 0.80; 95% Confidence interval [CI], 0.72 to 0.90; 

 <.001). Further analysis pointed to nonsignificant trends towards benefit for cardiovascular death (HR, 0.85; 95% CI, 0.71 to 1.01; 

=.07), heart failure hospitalization or urgent medical visit (HR, 0.82; 95% CI, 0.71 to 0.96), all-cause mortality (HR, 0.81; 95% CI, 0.71 to 0.93), an HbA1c of 6.5% or greater (HR, 0.27; 95% CI, 0.24 to 0.31).

The DAPA-MI trial was launched with the intent of assessing whether use of dapagliflozin in patients with acute myocardial infarction might reduce the risk of adverse cardiovascular and metabolic outcomes. An international, registry-based, randomized, double-blind trial, the endeavor enrolled patients without prior diabetes or chronic heart failure presenting with acute myocardial infarction and impaired left ventricular systolic function.

Patients were randomized to daily dapagliflozin 10 mg or placebo. The trial was designed with a hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last visit using the win ratio analysis method as the primary outcome of interest.

Upon analysis, results pointed to significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% CI, 1.20 to 1.50; 

.001), but further analysis indicated there was no significant difference for the composite of time to cardiovascular death/hospitalization for heart failure in patients assigned to dapagliflozin and patients assigned to placebo (2.5% vs 2.6%; [HR, 0.95; 95% CI, 0.64 to 1.40]).

Vaduganathan reports having received funding for consulting or research grants from Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others.

Greene reports having received funds for consulting or research grants from Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.

Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes [published online ahead of print, 2023 Nov 11]. 

. 2023;10.1056/NEJMoa2307563. doi:10.1056/NEJMoa2307563

James S, Erlinge D, Storey RF, et al. Dapagliflozin in myocardial infarction without diabetes or heart failure. 

. Published online 2023. doi:10.1056/evidoa2300286

Articles

In this episode, hosts sit down between sessions at AHA 2023 to discuss the landmark SELECT trial, their interpretation of the data, and its implications for care moving forward. Later in the episode, hosts break down the DAPA-MI trial.

Don't Miss a Beat: SELECT, DAPA-MI, & AHA 2023

The largest annual heart failure-specific meeting in the US, the 

Heart Failure Society of America (HFSA) Annual Scientific Meeting

 serves as a showcase for the latest innovations, advancements, and revelations, not only for advanced 

 specialists, but the continuum of the care team.

There may be no better example of this than the meeting’s sessions dedicated to late-breaking clinical trials. Among the trials headlining this year’s late-breaking session was the REBALANCE-HF trial, which was presented by Marat Fudim, MD, MHS, advanced heart failure specialist at Duke University Medical Center.

Billed by Axon Therapies as the largest randomized controlled, blinded, feasibility device trial in patients with heart failure with preserved ejection fraction (HFpEF) to date, REBALANCE-HF examined the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve in patients with HFpEF.

During his presentation, Fudim highlighted the safety and tolerability of the procedure, which had a 98% success rate and had a mean time to completion of less than an hour. In their release, Axon Therapies highlighted the following findings:

13-point improvement in quality-of-life at 6 months in treatment vs. sham (

= .02) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) score

36-meter improvement in ability to walk at 6 months in treatment vs. sham (

=.08) as measured by the 6-minute walk test

39% relative improvement in cardiac function at 6 months in treatment vs. sham (

Reduced filling pressures at 1 month as measured by peak pulmonary capillary wedge pressure of -4.5 mmHg (vs. peak PCWP of -1.6 mmHg for sham, 

With an interest in learning more about the trial, results, and what it could mean for patients with HFpEF, the hosts of 

, Muthiah Vaduganathan, MD, MPH, and Steve Greene, MD, reached out to Fudim to take part in a special edition episode recorded at HFSA 2023 in Cleveland, OH.

Fudim reports having received funds for consulting or research grants from Axon Therapies, Daxor, Bayer Corporation, Abbott Laboratories, and others.

Endovascular Ablation of The Right Greater Splanchnic Nerve In Heart Failure With Preserved Ejection Fraction: Responder Analysis Of The Rebalance-hf Randomized Trial

. Paper presented at: Heart Failure Society of America 2023 Annual Scientific Meeting; October 6 - 9; Cleveland, OH. Accessed October 8, 2023.

Axon Therapies. Late-breaking data confirms safety of Axon Therapies’ innovative heart failure procedure and identifies patients most likely to benefit from SAVM therapy. PR Newswire: press release distribution, targeting, monitoring and marketing. October 8, 2023. Accessed October 8, 2023. https://www.prnewswire.com/news-releases/late-breaking-data-confirms-safety-of-axon-therapies-innovative-heart-failure-procedure-and-identifies-patients-most-likely-to-benefit-from-savm-therapy-301950021.html?tc=eml_cleartime.

Hosts are joined by Marat Fudim, MD, MHS, of Duke, to discuss the REBALANCE-HF trial, which examined endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction.

Don't Miss a Beat: REBALANCE-HF, with Marat Fudim, MD, MHS

For years, the European Society of Cardiology (ESC) annual congress has stood as the most prominent international meeting in the field of cardiology.

In recent years, it has begun to take on the role of the foremost cardiology, regardless of location, and it appears the ESC is hoping this trend will continue as it prepares for the ESC Congress 2023, which will be conducted in Amsterdam and virtually from August 25-28, 2023. With thousands of unique abstracts and more than half a dozen hot line sessions planned for presentation, the meeting is expected to bring forth the latest advances across the spectrum of disciplines in cardiology. 

hosts Muthiah Vaduganathan, MD, MPH, codirector of the Center for Implementation Science at Brigham and Women’s Hospital, and Stephen Greene, MD, advanced heart failure specialist at the Duke Clinical Research Institute, sit down for a discussion surrounding the meeting itself and take a deep dive into 3 late-breaking trials from ESC Congress 2023: STEP HFpEF, HEART-FID, and the QUEST trials. Also included in this episode is a brief conversation on the topline results of the SELECT trial and what it means for management of cardiometabolic illness.

Being presented by Mikhail Kosiborod, MD, of St. Luke’s Mid America Heart Institute, in Hot Line Session 1 on August 25 at 11:15 CEST.

Double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of semaglutide against placebo in people living with heart failure and obesity.

Primary outcomes of interest included the change in body weight from the start to the end of the study and compare heart failure symptoms in those using semaglutide compared to placebo therapy.

Being presented by Robert Mentz, MD, of Duke Clinical Research Institute, in Hot Line Session 2 on August 26 at 9:14 CEST.

Double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo in people with heart failure and iron deficiency.

Primary outcomes of interest are 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test distance.

Being presented by Xinli Li, of the First Affiliated Hospital of Nanjing Medical University, in Hot Line Session 1 on August 25 at 8:30 CEST.

Double-blind, multicenter, parallel-group, randomized, placebo-controlled, event-driven study examining use of qiliqiangxin, a traditional Chinese medicine capsule, approved in China for the treatment of chronic heart failure.

Primary outcome of interest was a composite cardiovascular death and re-hospitalization due to the worsening of heart failure.

In this episode of Don't Miss a Beat, hosts offer a breakdown of 3 trials of note from the upcoming ESC Congress 2023 and provide context around the recent announcement of topline results from the SELECT trial. 