What’s Going to Be Big at TCT 2024?

TCT 2024, the annual scientific showcase of interventional cardiovascular medicine, is returning once again to Washington, DC.

The 4-day meeting starts Sunday, October 26, 2024, and will involve more than 1,400 faculty spread out across 161 different sessions, including 33 live endovascular, structural, and coronary cases. Three sessions, one per day, will deliver 11 late-breaking clinical trials, with another three showcasing 15 late-breaking science presentations. Rounding out the research-based talks are more than 1,000 moderated abstracts and 35 featured clinical research presentations.

In a telebriefing with the media last week, Program Director Juan Granada, MD (Cardiovascular Research Foundation, New York, NY), said course organizers received an “amazing number of submissions this year,” noting that roughly 10% of studies submitted as late-breaking clinical trials were accepted.

“We will have a strong global representation as we always do at TCT every year,” he added.

Sunday kicks off with the TCT Medtech Innovation Forum, which will offer talks from industry leaders, regulators, and scientists, and features three distinct tracks: global market dynamics, hot topics, and a US Food and Drug Administration “university” for start-up companies. This is the hot spot for discussions on device innovation, including when nonclinical testing needs to be repeated with iterative devices, and the impact of artificial intelligence (AI) on imaging, clinical-care pathways, and the healthcare system, Granada explained.

In a departure from Sunday’s device and tech focus is a symposium titled the “Ozempic Revolution,” which will focus on how the GLP-1 receptor agonists are affecting the medical device industry.

Earlier Interventions

Speaking with the media ahead of the meeting, Granada said one of TCT’s key themes is intervention as a means of prevention.

“Right now, we’re going through a transition in our field in which people are talking more about the early detection of disease and preemptive intervention in patients that actually still don’t have symptoms,” he said.

Earlier intervention is therefore the focus of the first late-breaking clinical trial (LBCT) session, presented in collaboration with the New England Journal of Medicine. The session kicks off Monday, October 28, 2024, at 11 AM in the Main Arena with results from the EARLY TAVR trial led by Philippe Généreux, MD (Morristown Medical Center, NJ). This study is a highly anticipated look into whether early intervention with transcatheter aortic valve implantation—as opposed to watchful waiting—will improve outcomes in asymptomatic patients with severe aortic stenosis and preserved left ejection fraction.

In the same session is the EVOLVED study led by Marc Dweck, MBChB, PhD (University of Edinburgh, Scotland), also testing earlier TAVI versus routine clinical care in asymptomatic patients with severe aortic stenosis plus evidence of myocardial fibrosis.

The third and final trial in LBCT 1 is an early-TAVI study, as well, this time in patients with moderate aortic stenosis and advanced heart failure: TAVR UNLOAD is investigating whether unloading the left ventricle with TAVI in addition to providing optimal heart failure therapy is superior to medical therapy alone.

“The session is a glimpse into what the future is going to bring in terms of getting early data in patients who are either asymptomatic or patients that don't actually have severe aortic stenosis and the effect of intervention in these patients,” said Granada. The idea of preventive intervention in asymptomatic patients has been controversial in patients with coronary disease, he noted.

Also speaking in the media briefing, Course Director Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York), stressed that LBCT 1 is not to be missed. “These are the trials that will change guidelines [if they] are positive,” she predicted. 

From Experience to Data

LBCT 2, on Tuesday morning and presented in collaboration with the Lancet, groups together four trials spanning coronary and endovascular interventions.

The ECLIPSE trial was led by Ajay J. Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), a TCT course director who joined Tuesday’s media briefing. ECLIPSE, he explained, is a randomized study of orbital atherectomy versus conventional balloon angioplasty in patients with severely calcified coronary lesions receiving a drug-eluting stent and will provide hard evidence in an area where operators largely rely on clinical experience.

“We think we know which therapies are better than others and we don't test them as much,” he said. “[ECLIPSE] is actually a large-scale, randomized trial testing specific devices that we use and it's important to do trials like that just because a lot of what we do can be experiential.”

In the same session, CLEAR SYNERGY will provide insight into the potential benefits of low-dose colchicine to reduce the risk of cardiovascular death, recurrent MI, or stroke in STEMI patients who underwent PCI. In PEERLESS, researchers are evaluating a strategy of large-bore mechanical thrombectomy against catheter-based thrombolysis in patients with intermediate-risk pulmonary embolism. Finally, the SIRONA investigators are comparing two different drug-coated balloons—one coated with sirolimus, the other with paclitaxel—for treatment of patients with symptomatic femoropopliteal disease. 

Valve Replacement and Intracoronary Insights

LBCT 3, on the last day of TCT 2024, combines four trials. First up are the full, final results from TRISCEND II, a trial testing transcatheter valve replacement for severe tricuspid regurgitation. Those will flesh out the 6-month results in the first 150 patients, which were presented at last year’s TCT and focused primarily on hemodynamic and functional outcomes. The full cohort was designed to include 400 patients, with a 12-month composite endpoint that assesses hard outcomes such as death, surgeries, and hospitalizations.

Next up are the 1-year outcomes from the ACURATE IDE trial, required for FDA approval of the Acurate neo2 TAVI device (Boston Scientific). That presentation will be followed by FLASH, a study comparing AI-based quantitative coronary angiography with optical coherence tomography to guide stent implantation. The last trial in the session is a comparison of quantitative flow ratio versus fractional flow reserve for guiding coronary revascularization.

“We’re really thrilled with the trials this year,” Kirtane summarized. “All 3 days have a lot that will be really applicable to patients and physicians in their practice.”

Late-Breaking Clinical Science

As in other years, the TCT program offers a second series of high-impact studies, many of which are registry-based or secondary analyses of randomized trials presented at earlier meetings. All three of the late-breaking clinical science (LBCS) sessions take place on the same days as the LBCTs but start at 2 PM each afternoon.

Monday’s LBCS block features five studies, presented in collaboration with the European Heart Journal. The DCB-BIF trial looks at the role of drug-coated balloon angioplasty for the treatment of coronary bifurcations, while the HELP-PPCI revisits the ideal timing of heparin administration in STEMI patients headed for with PCI. Remaining studies in the session include a comparison of distal radial versus transradial access in patients with STEMI undergoing PCI, 1-year outcomes from INFINITY-SWEDEHEART testing an “unlocking” coronary stent, and data from CONFIRM₂ where clinicians used an AI-enabled quantitative CT angiographic assessment of atherosclerosis to predict risk of major adverse cardiac events.

This last presentation ties in with the “intervention-to-prevention theme,” said Kirtane. “That’s one of the reasons why you’ll see studies like [CONFIRM₂] that use CT as a way of assessing what’s going on. We, as interventionalists, often find that patients come to us because they view us as the plaque experts, and that's something we embrace. We don't want to just push that off to preventative cardiologists.”

Kirtane stressed that if interventional cardiologists are treating coronary lesions but ignoring the disease, “we’re missing the boat.” 

Tuesday’s LBCS, presented in collaboration with the Journal of the American College of Cardiology, again features five studies. CO-STAR is testing colchicine versus placebo to prevent new-onset atrial fibrillation and conduction disturbances after TAVI. ACCESS-TAVI compares different strategies for vascular access closure after the procedure. Rounding out this session are 2-year data from ALIGN-AR, results from the US cohort in the PROTECTED TAVR trial of embolic protection, and a pooled analysis from the RHEIA and PARTNER 3 trials focused on TAVI outcomes in women.

The final late-breaking clinical science session, on Wednesday and presented in collaboration with Circulation, features two studies of the Firehawk biodegradable polymer sirolimus-eluting coronary stent (MicroPort): TARGET-IV and TARGET DAPT. Those are followed by data from the CLEAR Infective Endocarditis Registry, 2-year outcomes from CLASP IID comparing transcatheter edge-to-edge repair with the two market-approved devices, and a new atrial mitral regurgitation subset analysis from MATTERHORN. 

Dazed by Data?

Beyond the late-breaking studies, as in years past, are a range of FDA Town Hall sessions spanning Monday to Wednesday that address everything from progress in diversity, equity, and inclusion in clinical research to harmonizing global regulatory standards. Sunday will also see the annual Shark Tank Innovation competition, with six innovative ideas competing for the $200,000 award from the Jon DeHaan Foundation.

This year’s keynote speaker is Harvard professor Arthur C. Brooks, PhD, bestselling author of From Strength to Strength: Finding Success, Happiness, and Deep Purpose in the Second Half of Life, a nonfiction book discussing his own journey and tips for “strivers” aging past their prime.

On a lighter note, Tuesday is TCT’s second annual “white sneaker day,” so don’t forget to pack your favorite pair.