There’s no shortage of late-breaking trials and science, plus live cases, innovation forums, and AI-focused sessions, this year.

TCT 2025, the top US meeting for interventional cardiovascular medicine, is returning once again to San Francisco, CA, with the 4-day event kicking off on Saturday, October 25, at the Moscone Center.

There are several important themes this year, but a big one is that “coronary is back,” said Martin Leon, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), one of TCT’s program directors.

The meeting will feature highly anticipated studies testing sirolimus-eluting drug-coated balloons (DCBs) for coronary artery disease and use of intravascular lithotripsy for calcified lesions, as well as presentations and live cases around the use of coronary imaging, such as photon-counting CT angiography, to help plan procedures and provide the optimal treatment, he said.

“There had been a shift over to the structural side over the past many years, but there is more than equal representation of coronary at TCT this year,” said Leon, chairman emeritus of the Cardiovascular Research Foundation (CRF), the nonprofit organization behind TCT 2025.

AI Now and in the Future

In San Francisco, a city shaping the future of artificial intelligence (AI), it’s only fitting that there will be several tracks dedicated to the technology’s fundamentals, starting with an “AI 101 for the Health Care Practitioner.” There are sessions on how to integrate AI into the cath lab for coronary and structural heart disease procedures. Healthcare futurist Robert Wachter, MD (University of California, San Francisco), is scheduled to give the keynote lecture on how the technology will reshape the future of medicine. 

“At least 20% of submissions on innovation were related to AI,” said Juan Granada, MD, president and chief executive officer of CRF. “The field is moving so fast on detection algorithms for risk stratification, prediction models, and so forth that we felt this was the right year to have a dedicated track on AI. What we call the TCT AI Lab is a way of bringing the basic concepts of artificial intelligence to our community.”

TCT begins Saturday with the Nurse and Technologist Symposium, cases from expert coronary and structural operators, and the WorldLink Forum, with individual sessions that feature research across the gamut of interventional cardiology. There is also the daylong MedTech Innovation Forum.   

“If you’re looking for something to calibrate the future, to see where things are going, what’s happening with AI, what’s happening with robotics, what’s happening with biologics, and how certain things are going to influence the MedTech market, there’s going to be many discussions around these kinds of issues,” said Leon.

The TCT programmers say they’re excited to be back in San Francisco, noting that the city feels like it’s on an upswing. Program director Ajay Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), said that previous concerns about international travel, specifically with crossing into the United States, haven’t appeared to slow the meeting down.

“There’s a ton of interest, and we’re pretty excited about the overall prospects of the meeting,” he said.

Leon made a similar point, saying the metrics look very strong this year. He expects anywhere from 11,000 to 12,000 attendees, which is on par with prior highly attended TCTs, and that there’ll be roughly equal representation from US and non-US participants.

Late-Breaking Clinical Trials

This year’s meeting includes more than a dozen late-breaking clinical trials (LBCTs) that begin on Sunday, October 26, at 11 AM PDT. The first LBCT session, which is presented in collaboration with the Lancet, includes SELUTION DeNovo, one of the more highly anticipated trials comparing a sirolimus-eluting DCB (Selution; Cordis) against a drug-eluting stent in 3,300 patients with de novo coronary artery disease. The primary endpoint is target vessel failure at 1 year, a composite that includes cardiac death, target vessel-related MI, or clinically driven target-vessel revascularization.

The SELUTION4ISR study, in that same session, is comparing the same DCB against balloon angioplasty in more than 400 patients with in-stent restenosis.

“For interventionalists, we want to know how drug-coated balloons work compared with drug-eluting stents, because they’re all the rage,” said Kirtane. “A lot of people are talking about using them, but they’ve not been proven to be the same as a drug-eluting stent.”

Granada is also excited by the two DCB trials, noting that the field has had a bit of a “bumpy road” in the past few years. While the AGENT IDE trial led to the US approval of a paclitaxel-eluting DCB (Agent; Boston Scientific) for the treatment of in-stent restenosis, the real-world data for a range of DCBs presented last year were a little mixed. Leon noted that beyond the LBCTs, there are additional presentations, discussions, and live cases involving DCB technology.

The two other trials on day one involve patients with calcified lesions. In SHORT-CUT, investigators are comparing cutting balloon angioplasty to intravascular lithotripsy (Shockwave; Shockwave Medical) prior to DES implantation in 400 patients with moderately-to-severely calcified coronary artery disease, while VICTORY is a noninferiority comparison of intravascular lithotripsy versus a high-pressure noncompliant balloon in 280 patients with calcified and refractory coronary lesions.

Kirtane said that while intravascular lithotripsy is an “incredible device” for the management of coronary calcium, the unknown is how often it’s needed and whether there is less expensive technology that works just as well. These two trials will hopefully provide an answer, he said.

On Monday, October 27, the LBCT session, which is presented in collaboration with the New England Journal of Medicine, includes further clinical and echocardiographic follow-up of low-risk patients with aortic stenosis treated with TAVI or surgery in PARTNER 3. This represents the largest, longest follow-up of a randomized trial in the TAVI space, said Leon, who led the trial alongside Michael Mack, MD (Baylor Scott & White The Heart Hospital – Plano, TX).

The PARTNER 3 data at 1, 2, and 5 years are very good, “but the window for vulnerability for bioprosthetic valve durability is 5 to 10 years,” said Leon. “We’re now getting into the sweet spot of understanding if these transcatheter valves are similar to surgical valves from the standpoint of durability and other clinical outcomes.”

Additional presentations address 1-year outcomes of patients with severe mitral annular calcification who underwent transcatheter mitral valve replacement (TMVR) with Tendyne (Abbott) in the SUMMIT study, as well as 1-year outcomes in roughly 900 patients enrolled in ENCIRCLE, which is a single-arm study testing transseptal TMVR with a dedicated balloon-expandable valve (Sapien 3; Edwards Lifesciences).

Data from PREVUE-VALVE will also be presented. This is a decentralized study of 3,000 older adults across the US who underwent in-home echocardiography to determine the prevalence of acquired valvular heart disease. The study will provide the best data currently available on how various forms of valve disease vary with age, sex, race, and ethnicity, said David Cohen, MD (St. Francis Hospital, Roslyn, NY, and CRF, New York, NY), the study’s lead investigator and TCT program director. It will also provide a testing ground for deep learning-based algorithms that may serve as future screening tools for valve disease in the population. 

On Tuesday, October 28, the LBCT session, presented in collaboration with JAMA, will include five trials, among them PROCTOR. In that study, investigators are comparing MACE outcomes at 3 years among nearly 600 patients undergoing PCI of native coronary arteries versus saphenous vein grafts in those with prior CABG surgery. In STRIVE, investigators are testing adjunctive, low-dose intracoronary recombinant tPA against placebo in 200 STEMI patients undergoing PCI.

The other three trials part of the final LBCT session include a comparison of immediate iFR versus deferred cardiac magnetic resonance-guided revascularization of nonculprit lesions in patients with acute MI (iMODERN), a look at a precision-medicine strategy versus standard care in patients with MI with nonobstructive arteries, and TUXEDO-2, a test of the ultrathin Supraflex Cruz DES (SMT) in patients with diabetes and multivessel CAD.

Late-Breaking Clinical Science

There are an additional 15 late-breaking science presentations on Sunday, Monday, and Tuesday. These will cover 3-year follow-up from LIFE-BTK, 2-year outcomes from INFINITY-SWEDEHEART, 2-year data from IRONMAN II, and 3-year outcomes of REC-CAGEFREE I, and other topics. Importantly, attendees will see 10-year mortality data from NOBLE, a trial comparing PCI versus CABG surgery for patients with left main coronary artery disease.

Alongside the follow-up studies, the ANDES investigators will present short-term data on use of oral anticoagulation versus dual antiplatelet therapy for the prevention of device thrombosis in patients who undergo left atrial appendage closure. There will also be new results for therapies designed to treat tricuspid regurgitation, including transcatheter edge-to-edge repair with TriClip (Abbott) in TRILUMINATE and early US commercial experiences with transcatheter tricuspid valve replacement (Evoque; Edwards Lifesciences).

Plus, TCT will include multiple presentations on identifying and treating patient populations left behind in areas such as MI, aortic stenosis, and pulmonary embolism. To TCTMD, Granada stressed that access to care is an important focus of this year’s meeting. The development of cutting-edge devices and procedures is for naught if such care isn’t reaching patients equitably.

“I am at a stage in my career where I’m exposed to the most innovative technologies that humans can develop at the present time,” he said. “But when I travel, I see that access is a problem. Patients are not really getting access to technologies because hospitals cannot really pay for them.”

“Steering the boat” in the direction of sustainable technology that is affordable is critical, and possible, particularly with the emergence of AI-based innovation that can screen patients and identify those at risk, he said.

Leon said the US Food and Drug Administration will continue to have a presence, albeit smaller than usual, at this year’s meeting, noting that officials have received a special dispensation to attend. Former commissioner Robert Califf, MD (Duke University School of Medicine, Durham, NC), will speak on whether cardiovascular science and research are headed in the right direction.