ESC Congress Recap: High-Impact Clinical Trials, with Deepak Bhatt, MD, MPH, MBA

With 32,000 attendees from more than 170 countries, the European Society of Cardiology (ESC) Congress 2024 demonstrated how it has earned the reputation as 1 of the foremost scientific meetings in cardiology and medicine as a whole. Boasting 4,400 novel abstracts, including 112 studies simultaneously published in medical journals, the meeting served as a platform for debuting science and breakthroughs that could impact standards of care for cardiovascular disease management and prevention for decades.

A sequel to our ESC Congress preview, our editorial team sat down with Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Heart and the Dr. Valentin Foster Professor of Cardiovascular Medicine at the Icahn School of Medicine, for his post-conference perspective on the meeting’s top trials and new data releases. In the featured video, Bhatt highlights a group of 4 studies from the meeting: FINEARTS-HF, ABYSS, RESHAPE-HF2, and SHAM-PVI.

FINEARTS-HF

Less than a month after announcement of topline results, FINEARTS-HF was presented at ESC Congress. Primary endpoint data indicated use of finerenone was associated with a statistically significant 16% relative reduction in rate of a composite endpoint of cardiovascular death and total heart failure events compared with placebo therapy (rate ratio [RR], 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007).¹

At ESC Congress, a breakdown of individual components of the primary endpoint suggested use of finerenone was associated with an 18% relative reduction in incidence of heart failure hospitalization (RR, 0.82; 95% CI, 0.71 to 0.94; P = .006) and nonsignificant 7% relative risk reduction for death from cardiovascular causes (Hazard Ratio [HR], 0.93; 95% CI, 0.78 to 1.11).¹

ABYSS

ABYSS examined the use of beta-blockers among 3698 patients with a LVEF of at least 40% who had a history of myocardial infarction at least 6 months before enrollment and were being treated with beta-blockers. Patients were randomized 1:1 ratio to continuation or interruption of beta-blocker medication and followed for a composite endpoint of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow-up.²

Results indicated a primary outcome event occurred among 23.8% of the interruption group compared to 21.1% of the continuation group (risk difference, 2.8 percentage points; 95% CI, <0.1 to 5.5; HR, 1.16; 95% CI, 1.01 to 1.33; P = .44 for noninferiority). Secondary outcomes analysis revealed the mean change in EQ-5D from baseline to last follow-up was 0.033 (SD, 0.150) in the interruption group and 0.032 (SD, 0.164) in the continuation group (mean difference, 0.002; 95% CI, −0.008 to 0.012).²

RESHAPE-HF2

RESHAPE-HF2 trial was designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. The trial enrolled and randomized 505 patients from 30 sites across 9 countries in a 1:1 ratio to either M-TEER or optimal medical therapy.³

The trial met each of its 3 primary endpoints, with a statistically significant effect on a composite of cardiovascular death and hospitalization for heart failure (RR, 0.64; 95% CI, 0.48 to 0.85; P = .002), hospitalization for heart failure (RR, 0.59; 95% CI, 0.42 to 0.82; P = .002), and change in KCCQ-OS (Least-squares mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P <.001). M-TEER was also associated with significant improvements in the rate of grade 2 or greater mitral regurgitation at 12 months (Difference, 21.3 events; 95% CI, 10.7 to 45.8; P <.001) and mean change in 6-minute walk distance from baseline to month 12 (Difference, 20.5; 95% CI, 0.3 to 40.7; P = .05).³

SHAM-PVI

SHAM-PVI was a double-blind randomized clinical trial designed to assess whether pulmonary vein isolation was more effective than a sham procedure for improving outcomes in atrial fibrillation among a cohort of patients with symptomatic paroxysmal or persistent atrial fibrillation. A total of 126 patients were enrolled in the trial, with 64 undergoing pulmonary vein isolation with cryoablation and 62 undergoing a sham procedure with phrenic nerve pacing.⁴

Results demonstrated the ablation group experienced a greater absolute mean atrial fibrillation burden change from baseline to 6 months(60.31% vs 35.0%; geometric mean difference, 0.25; 95% CI, 0.15 to 0.42; P < .001), greater estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months (Difference, 18.39 points; 95% CI, 11.48 to 25.30 points), and greater improvement on the Short Form 36 general health score at 6 months (Estimated difference, 9.27 points; 95% CI, 3.78 to 14.76 points).⁴

References:

1. Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. Published online September 1, 2024. doi:10.1056/NEJMoa2407107
2. Silvain J, Cayla G, Ferrari E, et al. Beta-Blocker Interruption or Continuation after Myocardial Infarction. N Engl J Med. Published online August 30, 2024. doi:10.1056/NEJMoa2404204
3. Anker SD, Friede T, von Bardeleben RS, et al. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. Published online August 31, 2024. doi:10.1056/NEJMoa2314328
4. Dulai R, Sulke N, Freemantle N, et al. Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation: The SHAM-PVI Randomized Clinical Trial. JAMA. Published online September 02, 2024. doi:10.1001/jama.2024.17921