Top Coronary Artery Disease News in 2024

The field of coronary artery disease saw its share of negative trials in 2024, but also got new guidelines, and a truce between interventionalists and surgeons.

One long-awaited trial stood out: DanGer Shock (DANGER; 22 Across). In the 360-patient study, use of mechanical circulatory support with the Impella CP (Abiomed) microaxial flow pump lowered the risk of mortality at 180 days when compared with standard care in patients with STEMI complicated by cardiogenic shock.

“The biggest news, far and away, was DanGer Shock,” interventional cardiologist Sanjit Jolly, MD (McMaster University/Hamilton Health Sciences, Canada), told TCTMD, noting the field of cardiogenic shock is peppered with negative studies. “The trial took more than 10 years to complete, and finally showed that an intervention with the microaxial flow pump, Impella, reduced mortality in cardiogenic shock.”

Safety was a concern in the trial, but the overall positive results filled a large gap in the evidence base. Hospitals around the world are likely organizing treatment protocols in alignment with the DanGer Shock trial, Jolly added.

Ajay Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), agreed that DanGer Shock was one of the 2024’s biggest studies.

“At the end of the day, you have to bring it back to patients,” Kirtane told TCTMD, noting that DanGer Shock is not a license for indiscriminate use of Impella in acute MI cardiogenic shock. The way investigator Jacob Møller, MD, PhD, DMSc (Odense University Hospital, Denmark), presented the trial, said Kirtane, it “was pretty clear that there was selection criteria applied that allowed the device to show a benefit. If you just use it indiscriminately, then that might not be the case.”

The DanGer Shock data also had repercussions for RECOVER IV (RECOVERIV; 2 Down), a similar study in the works. The Data and Safety Monitoring Board no longer felt there was clinical equipoise between Impella and standard care in this setting, leading investigators to wind down the study after enrolling just five patients.

This year also saw the US approval of Boston Scientific’s Agent balloon (AGENT; 31 Down), for the treatment of coronary in-stent restenosis. In AGENT IDE, investigators showed there was significantly less target lesion failure at 12 months with the drug-coated balloon (DCB; 47 Down) compared with uncoated balloon angioplasty, and the resulting approval led physicians to ponder the myriad ways the new device would change their approach to treating in-stent restenosis.

There is definitely an interest in DCBs for coronary artery disease, said Jolly, noting the devices have been available in Canada for several years. While AGENT IDE showed the technology was effective for in-stent restenosis, a paclitaxel-coated balloon proved inferior to a drug-eluting stent in a broad group of patients with noncomplex coronary lesions in the REC-CAGEFREE I study.

With AGENT IDE and REC-CAGEFREE I, “there was a win and a loss” for DCBs, said Jolly. “It’s certainly a technology that has a role, particularly in terms of restenosis, but I think in terms of replacing drug-eluting stents, that doesn’t look like it’s the case at this point.”

Reimbursement for DCBs is expected in 2025, said Kirtane, which is important because roughly 10% of coronary interventions are for in-stent restenosis. Both Jolly and Kirtane noted that there was a suggestion of benefit with DCBs in patients with small-vessel disease in the REC-CAGEFREE I study, a group where operators are reluctant to place a stent.

“It doesn’t mean that one therapy is going to displace another,” said Kirtane. “It means that it’s great to have an additional therapy in our armamentarium.”    

Negative Studies

Some of the top trials of 2024 investigated therapies that didn’t pan out.

The ECLIPSE (ECLIPSE; 38 Across) trial, for one, cast a shadow on the use of orbital atherectomy in patients with calcified lesions. When compared with conventional balloon angioplasty, there was no significant difference in the primary endpoint of target vessel failure at 1 year, leading investigators to conclude that with meticulous lesion preparation, the simplest—and cheapest—approach may work best when dealing with calcified lesions. 

“As much as [ECLIPSE] is a negative trial, it’s really very important because it suggests that a balloon-first strategy, where you use atherectomy as a bailout, is probably safer in general and is the way to go,” said Jolly. “Sometimes we like to do things that are more complex, but in fact sometimes simpler is better. Kudos to the investigators for pulling off that trial, because patients with calcified disease have poor outcomes and we sometimes think that doing more is better, but obviously it wasn’t in this trial.”

With pharmacotherapy, there were also some letdowns. While colchicine (COLCHICINE; 24 Down), sold by Agepha Pharma as Lodoco, was approved last year for reducing cardiovascular events in adults with or at high risk for atherosclerotic cardiovascular disease, the CLEAR SYNERGY (OASIS 9) study showed that routine use of the anti-inflammatory agent following PCI for acute myocardial infarction failed to reduce the risk of major adverse cardiovascular events. 

Jolly noted that the European Society of Cardiology (ESC) recently bumped colchicine up in the chronic coronary syndrome guidelines to a IIa recommendation so it’ll be interesting to see if that recommendation is changed again. The other part of CLEAR SYNERGY, which was a 2x2 factorial study, tested spironolactone. While negative, there was a reduction in heart failure events, suggesting mineralocorticoid antagonists may be useful post-MI in patients with or at high risk for heart failure, said Jolly.

Another negative study, one that may have finally put an end to the long-term use of beta-blockers (BETA; 36 Down) in patients with acute MI and preserved ejection fraction, was REDUCE-AMI. In that trial, investigators showed the drugs did not reduce the risk of death or recurrent MI in the modern era of post-MI care. On the other hand, the ABYSS trial showed that discontinuing beta-blocker therapy in patients several years after an MI might actually be harmful.

No end-of-year list would be complete without mentioning coronary revascularization for left main disease, an area of heated debate over the last 5 years. Back in 2019, the European Association for Cardio-Thoracic Surgery (EACTS) dropped their support for the left main CAD section of the ESC revascularization guidelines after a controversy involving the 5-year EXCEL outcomes (EXCEL; 37 Across). The newest ESC guidelines for the treatment of patients with chronic coronary syndrome, however, recommended coronary artery bypass surgery (CABG; 8 Across) over PCI for most patients with left main disease, gaining EACTS endorsement this time around. At this year’s meeting, surgeons suggested that the long-simmering rift between some surgeons and interventional cardiologists may now be in the rearview mirror.