Maybe it’s just March! With NCAA Men’s and Women’s “Madness” and extensive “bracketology” all around, I shouldn’t be surprised that the American College of Cardiology’s Annual Scientific Meeting, which just concluded in Atlanta, appeared to have a lot of suspense as many trials were closely watched and even debated in the medical press and conferences ahead of the ACC Meeting — all awaiting the moment of reality: The trial results. So, let’s briefly look at my “Final Four” trials from ACC 2024.
ORBITA-COSMIC: Coronary Sinus Reducer: Impact on clinical symptoms and mechanism of effect
This was a small (51 patients) randomized trial of a coronary reducer to reduce angina in a group of patients with refractory angina and no revascularization options. In addition to proof of concept, the trial utilized stress myocardial magnetic imaging to assess the impact on myocardial blood flow. Patients receiving the reducer showed significantly less angina at six months, taking 10 weeks to reach effect. However, the overall myocardial flow did not change for either group to definitively explain the effect, although there was a suggestion that the reducer patients may have better subendocardial perfusion.
Final Score: A small study, but it is encouraging that the coronary sinus reducer may improve angina in patients with refractory angina but the mechanism remains unclear.
DanGer Shock: Use of a micro-axial pump in patients with MI
A total of 355 patients with MI-related cardiogenic shock were randomized 1:1 to receive an Impella 3.5 pump in addition to the standard of care applied to all patients. The study took 10 years to enroll. The primary endpoint was all-cause mortality at six months, which was significantly reduced in the Impella group by 45.8% vs. 58.5%, p=0.04, with the number needed to treat 8. Overall complications were significantly higher in the Impella group, 24.0% vs. 6.2.
Final Score: Importantly, the investigators completed the first randomized trial of Impella use in cardiogenic shock with a mortality reduction of 13% in a population known to have a 50-60% mortality, which is impressive. Addressing broader populations and contemporary complication management will continue to be a focus, given the benefit of Impella hemodynamic support.
PREVENT: Stenting High Risk plaques to prevent later events
The investigators randomized 1600 patients, comparing standard therapy to all vs the addition of “preventive” stenting of a nonobstructive lesion. Characteristics of high-risk plaques were denoted by intravascular imaging, including greater than 70% plaque volume, thin fibrous cap, or lipid-rich plaques. After a 2-year follow-up, the stented patients exhibited a composite endpoint of acute coronary events of only 0.4% compared to 3.4% in the unstented, optimal medical group. There were no differences in the complications for either group.
Final Score: While encouraging that imaging techniques may effectively predict high-risk plaques and that stenting might provide a type of “protection” against future events, the authors note that more studies are needed to confirm these findings and better define patient types. Other commenters have emphasized the importance of the results to prevent unnecessary stenting without benefit.
REDUCE-AMI: Randomized Trial to assess potential to reduce beta blocker use post acute myocardial infarction (AMI)
Given current revascularization for AMI in patients with preserved left ventricular function (LVEF>50%), is there still value in the routine use of beta blockers? The investigators randomized 5,020 patients to beta-blocker treatment vs none. The primary composite endpoint of all-cause death or nonfatal AMI for beta-blocker versus no beta-blocker after a mean follow-up of 3.5 years was 7.9% vs. 8.3%, p=0.64. There were limits in terms of compliance and some crossover after one year. Other outcomes, such as heart failure admissions, AMI, and all-cause death, were not different either.
Final Score: The use of routine beta blockers post-MI may be unnecessary in patients with normal left ventricular ejection fractions.
Overtime:
I can’t end without one additional basketball parallel. This year, Caitlin Clark further energized women’s basketball to rival scoring, attendance, and recognition of sports in general. A great step forward. Likewise, the ACC inaugurated its first non-physician president — Cathy Biga, a very accomplished nurse, service line manager, and practice administrative consultant, again emphasizing the opportunities to diversify our focus and leadership. Congratulations to all.
Dr. Vetrovec has no conflicts of interest to report.
Illustration by Jennifer Bogartz and April Brust
