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Highlights of ACC 2024

09 Apr 2024
ACC 2024 Highlights

The American College of Cardiology (ACC) held its 73rd annual scientific session and expo April 6-8, 2024 in Atlanta, Georgia. Here is our curated list of the top sessions.

EMPACT-MI1 (NCT04509674) studied the effects of empagliflozin in patients who have experienced myocardial infarction (MI). Investigators assessed if empagliflozin could lower the risk of hospitalization for heart failure (HF) or death from cardiovascular disease (CVD). Patients received either empagliflozin (n=3260) or placebo (n=3262) for a median period of 17.9 months. At follow-up, there were no statistically significant differences between the two groups.

BALANCE2 (NCT04568434) evaluated the efficacy of olezarsen as compared to placebo to lower fasting triglyceride (TG) levels. A total of 66 patients with familial chylomicronemia syndrome (FCS) received either olezarsen (n=43) or placebo (n=23). In the olezarsen group, 21 patients received 50mg doses, and 22 patients received 80mg doses. The percent change from baseline in fasting triglycerides (TG) at six months served as the primary outcome measure. In the 80mg olezarsen group, this change was statistically significant; in the 50mg group, it was not. Investigators concluded that in patients with FCS, olezarsen may represent a new therapy to reduce plasma TG levels.

Bridge-TIMI 73a3 (NCT05355402) compared the efficacy of olezarsen with placebo at lowering fasting TG levels in moderate or severe hypertriglyceridemia. A total of 154 patients with moderate or severe hypertriglyceridemia received either olezarsen or placebo. Patients who received olezarsen received either a 50mg or an 80 mg dose. The percent change from baseline in fasting TG at six months served as the primary outcome measure. In patients with predominantly moderate hypertriglyceridemia at elevated cardiovascular risk, olezarsen significantly reduced levels of triglycerides.

SMART4 (NCT04722250) studied patients with severe aortic stenosis and a small aortic annulus who underwent transcatheter aortic valve replacement (TAVR). A total of 716 patients underwent TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. At 12 months, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes. The self-expanding valve was also superior with respect to bioprosthetic-valve dysfunction through 12 months.

STEP-HFpEF DM5 (NCT04916470) explored the effects of semaglutide in obesity-related HF with preserved ejection fraction (HFpEF) and type 2 diabetes. Investigators randomized 616 adult patients with HFpEF and obesity to receive either once weekly semaglutide (n=310) or placebo (n=306). Patients receiving semaglutide showed a greater change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary scores at 52 weeks than placebo. Semaglutide was also associated with a greater change in body weight than placebo.

The DanShock6 trial (NCT01633502) evaluated the ability of the Impella CP ventricular assist device to decrease death following MI. The Impella CP is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation. It is able to deliver 3.5L/min (approximately 75% of a normal cardiac output). Investigators randomized 360 patients to receive a microaxial flow pump plus standard of care (SOC) (n=179) or SOC alone (n=176). The primary endpoint designated was death from any cause at 180 days. Death from any cause occurred in 82 patients (45.8%) in the microaxial-flow-pump + SOC group. In the SOC alone group, death from any cause occurred in 103 patients (58.5%) (hazard ration [HR] of 0.74; confidence interval [CI] 0.55 to 0.00; P=0.04).

RELIEVE-HF7 (NCT03499236) evaluated the efficacy and safety of the V-wave interatrial shunt system in patients with HF. The primary endpoint was a composite of all-cause mortality, left ventricular assist device (LVAD)/heart transplantation, HF hospitalizations, worsening HF, and KCCQ score changes. Among patients with HFpEF, those who received the shunt experienced poor outcomes than those who did not. In contrast, outcomes were better in patients with HF with reduced EF (HFrEF). Patients with HFrEF who received the shunt experienced 55% fewer cardiovascular events than those who did not.

TACT-28 (NCT02733185) assessed if chelation therapy could reduce recurrence of cardiac events in diabetic patients with prior MI. Patients were randomized to receive 40 weeks of edetate disodium-based chelation and high-dose oral vitamins (n=483) or placebo (n=476). The primary endpoint consisted of a composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. At 48 month follow-up, there was no significant reduction in the primary endpoint in patients who had received chelation therapy. Although the first TACT trial showed positive results, TACT-2 did not replicate these results. Notably, 32% of patients did not complete the full treatment regimen. Investigators also speculated that TACT-2 may have been negative due to declining blood levels of lead in the population. Interestingly, inclusion criteria did not specify a baseline blood level of lead. In addition, the emergence of newer diabetic agents over the past decade may have contributed to negative TACT-2 findings.

REDUCE-SWEDEHEART9 (NCT03278509) evaluated the decreased usage of beta blockers after MI. Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with MI and normal heart function. Investigators randomized 5020 patients to either long-term treatment with a beta-blocker (metoprolol or bisoprolol) (n=2508) or no beta-blocker treatment (n=2512). Patients were followed for a median of 3.5 years. The primary endpoint was a composite of death from any cause or new MI. The risk of the primary endpoint was no lower in patients who received beta blockers than those who did not.

ULTIMATE-DAPT10 (NCT03971500) studied single antiplatelet therapy outcomes in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI). Investigators compared clinical outcomes with ticagrelor alone with ticagrelor plus aspirin. Patients were randomized to receive ticagrelor plus aspirin (n=1700) or ticagrelor plus placebo (n=1700) and followed for 12 months. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (a composite of cardiac death, MI, ischaemic stroke, stent thrombosis, or target vessel revascularisation). Patients treated with ticagrelor alone had a lower rate of clinically relevant bleeding than patients treated with ticagrelor plus aspirin. The rate of MACCE was similar between the two groups.

DEDICATE-DZHK611 (NCT03112980) trial aimed to compare the outcomes of transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR) in low-risk patients with severe aortic stenosis. Conducted in Germany at 38 sites, the randomized noninferiority trial assigned patients to either TAVI or SAVR. A total of 1414 patients participated, with a mean age of 74 years and predominantly low surgical risk. The primary outcome, a composite of death from any cause or fatal/nonfatal stroke at 1 year, showed a lower incidence in the TAVI group (5.4%) compared to the SAVR group (10.0%). TAVI was deemed noninferior to SAVR regarding this outcome (hazard ratio 0.53). Additionally, TAVI demonstrated lower rates of death from any cause (2.6% vs. 6.2%) and stroke (2.9% vs. 4.7%) compared to SAVR. Procedural complications were slightly more frequent in the TAVI group. The study concluded that among low-risk patients with severe aortic stenosis, TAVI is as effective as SAVR in terms of the composite outcome of death or stroke at 1 year.

The PREVENT12 (NCT02316886) trial aimed to determine if performing preventive PCI on non-flow-limiting vulnerable plaques yields better clinical outcomes compared to relying solely on optimal medical therapy. Conducted at 15 research hospitals across South Korea, Japan, Taiwan, and New Zealand, the trial enrolled 1606 patients. These patients were identified to have non-flow-limiting vulnerable coronary plaques through intracoronary imaging. Participants were randomly assigned to receive either PCI plus optimal medical therapy or optimal medical therapy alone. Over a 2-year follow-up period, the trial found that patients who underwent preventive PCI experienced significantly fewer major adverse cardiac events compared to those treated with medical therapy alone. Specifically, the primary outcome—a composite of death from cardiac causes, target-vessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalisation for unstable or progressive angina—occurred in only 0.4% of patients in the PCI group compared to 3.4% in the medical therapy group. The benefit of PCI was consistent across all components of the primary composite outcome. Moreover, serious clinical or adverse events did not significantly differ between the PCI and medical therapy groups. Specifically, there were fewer deaths and myocardial infarctions in the PCI group compared to the medical therapy group at the 2-year mark. These findings suggest that preventive PCI can effectively reduce major adverse cardiac events arising from non-flow-limiting, high-risk vulnerable plaques. The results advocate for considering PCI as a treatment option for such plaques, potentially expanding the indications for PCI in coronary artery disease management.

ORBITA-COSMIC13 (NCT04892537) aimed to evaluate the efficacy of the coronary sinus reducer (CSR) in reducing angina symptoms and improving myocardial perfusion in patients with stable coronary artery disease. Conducted at six UK hospitals, the double-blind, randomized, placebo-controlled trial enrolled 61 patients. Participants received either CSR or placebo and underwent various assessments including adenosine-stress perfusion cardiac magnetic resonance scans and symptom monitoring via a smartphone application over a 6-month period. Results showed that CSR did not improve transmural myocardial perfusion compared to placebo. However, CSR did significantly reduce the number of daily angina episodes compared to placebo. Although there were two CSR embolisation events, no acute coronary syndrome events or deaths occurred in either group. These findings suggest that while CSR may not improve myocardial perfusion, it effectively alleviates angina symptoms in patients with stable coronary artery disease. Thus, CSR could be considered as an additional antianginal option for such patients.

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Author: Kelly Schoonderwoerd

References

  1. Butler J et al. New Engl J Med. April 6, 2024.
  2. Stroes ESG et al. New Engl J Med. April 7, 2024.
  3. Bergmark BA et al. New Engl J Med. April 7, 2024.
  4. Herrman HC et al. New Engl J Med. April 7, 2024.
  5. Kosiborod MN et al. New Engl J Med. April 6, 2024.
  6. Møller JE et al. New Engl J Med. April 7, 2024.
  7. Stone GW. A double-blind, randomized, placebo-procedure-controlled trial of an interatrial shunt in patients with HFrEF and HFpEF: principal results from the RELIEVE-HF trial. Presented at: ACC 2024. April 6, 2024. Atlanta, GA.
  8. Lamas GA. The effect of edetate disodium-based chelation on cardiovascular events in patients with a prior myocardial infarction and diabetes–results of the TACT2 randomized trial. Presented at ACC 2024. April 7, 2024. Atlanta, GA.
  9. Yndigegn T et al. New Engl J Med. April 7, 2024.
  10. Zhen G et al. The Lancet. April 7, 2024.
  11. Blankenberg S et al. N Engl J Med. April 8, 2024.
  12. Park S-J et al. Lancet. April 8, 2024.
  13. Foley MJ et al. Lancet. April 8, 2024.

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