ACC.24 Clinical Trials Recap, with Deepak Bhatt, MD, MPH, MBA

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Deepak Bhatt, MD, MPH, MBA, provides a recap of top trials and new data from the American College of Cardiology's 2024 Annual Scientific Session.

Evidenced by the more than 17,000 attendees, the American College of Cardiology 2024 (ACC.24) Annual Scientific Session served as a showcase for the latest in clinically impactful advancements for the cardiology community.

Although the sheer number of attendees serves as a testimony to the field’s seat at the table in public health discussions, this year’s meeting also brought forth a multitude of updates with immediate practice-changing implications. Many of which were spotlighted by the ACC in the meeting’s 5 late-breaking sessions, which featured more than 20 trials, including 13 simultaneously published in the American College of Cardiology, the New England Journal of Medicine, and the Journal of the American Medical Association.

Ahead of ACC.24, HCPLive Cardiology sat down with Deepak Bhatt, MD, MPH, MBA, the Dr. Valentin Fuster Professor of Cardiovascular Medicine and director of Mount Sinai Heart, to learn what trials he was most excited for at the upcoming meeting. Now, with ACC.24 completed, we caught up with Bhatt for his perspective on the most important trials presented at the meeting and how they influence practice or research.

ACC.24 CLINICAL TRIALS RECAP

EMPACT MI1

EMPACT-MI was an event-driven, double-blind, randomized, placebo-controlled trial, which randomized 6522 patients in a 1:1 ratio to empagliflozin or placebo 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 heart failure and all-cause mortality assessed in a time-to-first-event analysis.

Results indicated 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; P= .21). Further analysis revealed 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).

REDUCE-AMI2

A registry-based, prospective, open-label, parallel-group, randomized clinical trial, REDUCE-AMI randomized patients from the SWEDEHEART registry with a recent acute myocardial infarction and ejection fraction greater than 50% in a 1:1 ratio to long-term beta-blocker or no beta-blocker. The primary outcome of interest for the trial was a composite of all-cause mortality or new myocardial infarction.

With a median follow-up of 3.5 years, results of the study suggested there was no statistically significant benefit to beta blockade observed in the trial (HR, 0.96; 95% CI, 0.79 to 1.16; = .64). Further analysis suggested the long-term beta-blocker strategy did not contribute to a reduced incidence of all-cause mortality (3.9% in the beta-blocker group and 4.1% in the no-beta-blocker group), cardiovascular mortality (1.5% and 1.3%, respectively), myocardial infarction (4.5% and 4.7%, respectively), hospitalization for atrial fibrillation (1.1% and 1.4%, respectively), or hospitalization for heart failure (0.8% and 0.9%, respectively).

ULTIMATE DAPT3

ULTIMATE DAPT was a randomized, placebo-controlled, double-blind clinical trial aimed at assessing ideal duration of DAPT in a population of patients who had undergone DAPT for 1 month following PCI for an acute coronary syndrome. After the first month, 3400 patients were randomized in a 1:1 to either continue DAPT or switch to ticagrelor and a placebo for 11 months.

The trial’s primary outcome of interest was clinically relevant bleeding (BARC 2, 3 or 5) at 1 year. Results indicated bleeding events occurred among 4.6% patients contusing DAPT and 2.1% using ticagrelor monotherapy (HR, 0.45; 95% CI, 0.30 to 0.66; P <.0001). The composite outcome occurred among 3.7% of patients who continued DAPT and 3.6% of those taking ticagrelor monotherapy experiencing such events (HR, 0.98; 95% CI, 0.69 to 1.39; P for noninferiority <.0001; P for superiority = .89).

DanGer Shock4

One of the most discussed trials throughout the meeting, DanGer Shock was an international, open-label trial randomizing patients with STEMI complicated by cardiogenic shock to standard of care or standard of care plus an Impella CP pump before, during or up to 12 hours after receiving treatment in the cardiac catheterization laboratory.

The trial used all-cause mortality as the primary outcome of interest. Results suggested the primary outcome occurred among 45.8% of the Impella CP group and 58.5% of the standard of care group (HR, 0.74; 95% CI, 0.55 to 0.99; P = .04), which correlates to a number needs to treat of 8. Further analysis pointed to a statistically significant reduction in need for additional mechanical heart support, heart transplant or death with the Impella CP (HR, 0.72; 95% CI, 0.55 to 0.95; P = .04)

AEGIS-II5

A cohort of 18,231 patients with a recent acute myocardial infarction, multi vessel coronary artery disease, and additional cardiovascular risk factors in a 1:1 ratio to weekly injection of CSL112, a 6 mg infusion of apolipoprotein A-I (ApoA-1), or placebo therapy. The trial’s primary outcome of interest was time to first occurrence of a composite of cardiovascular death, myocardial infarction, or stroke from randomization through 90 days.

Results of the trial indicated a primary outcome event occurred among 4.8% receiving CSL112 and 5.2% of those receiving placebo (HR, 0.93; 95% Confidence Interval [CI], 0.81 to 1.05; P= .24). In those with elevated baseline LDL-C, results pointed to statistically significant reductions for risk of the primary composite endpoint relative to placebo at 90 days ([3.4% vs 4.9%] HR, 0.69; 95% CI, 0.53 to 0.90; P = .007), 180 days ([5.3% vs 7.3%] HR, 0.71; 95% CI, 0.57 to 0.88; P= .002), and 365 days ([7.8% vs 9.9%] HR, 0.78; 95% CI, 0.65 to 0.93; P= .006).

Relevant disclosures for Bhatt include Amarin, AstraZeneca, Sanofi, Pfizer, Roche, Amgen, and Eli Lilly and Company, among others.

References:

  1. Butler J, Jones WS, Udell JA, et al. Empagliflozin after Acute Myocardial Infarction. N Engl J Med. Published online April 6, 2024. doi:10.1056/NEJMoa2314051
  2. Yndigegn T, Lindahl B, Mars K, et al. Beta-Blockers after Myocardial Infarction and Preserved Ejection Fraction. N Engl J Med. Published online April 7, 2024. doi:10.1056/NEJMoa2401479
  3. Ge Z, Kan J, Gao X, et al. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial. Lancet. Published online April 5, 2024. doi:10.1016/S0140-6736(24)00473-2
  4. Møller JE, Engstrøm T, Jensen LO, et al. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. Published online April 7, 2024. doi:10.1056/NEJMoa2312572
  5. Gibson CM, Duffy D, Korjian S, et al. Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction. N Engl J Med. Published online April 6, 2024. doi:10.1056/NEJMoa2400969
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