The Cardiovascular Research Foundation (CRF®) is set to unveil a series of groundbreaking clinical trials and scientific studies at the upcoming Transcatheter Cardiovascular Therapeutics (TCT®) 2025 symposium. Held annually in San Francisco, this premier scientific meeting has been at the forefront of interventional cardiovascular medicine for over three decades, drawing in leading clinicians, researchers, and innovators worldwide. From October 25 to 28, the Moscone Center will host this assembly of expertise, offering a platform for unveiling novel therapies, advanced devices, and new procedural techniques poised to transform the diagnosis and management of cardiovascular disease.
TCT® 2025’s late-breaking clinical trial sessions promise to deliver unprecedented insights into the evolving landscape of cardiovascular intervention. Over 28 pioneering studies will be presented, highlighting advances in minimally invasive procedures, next-generation pharmaceuticals, and state-of-the-art technologies. These studies emphasize the ongoing commitment of the cardiovascular community to improve patient outcomes, reduce procedural risks, and elevate therapeutic efficacy in combating heart and vascular diseases.
Among the landmark presentations, the SELUTION DeNovo Trial stands out, featuring one-year results comparing a percutaneous coronary intervention (PCI) strategy utilizing a sirolimus-eluting balloon with provisional stenting against systematic drug-eluting stent (DES) implantation. This trial critically addresses the balance between device implant avoidance and the risk of restenosis, potentially redefining the approach to de novo coronary lesions. Dr. Christian M. Spaulding leads this investigation, offering new perspectives on optimizing PCI techniques through drug delivery via balloons, minimizing metallic scaffold implantation.
The growing challenge of calcified coronary artery disease will be tackled by multiple trials employing intravascular lithotripsy (IVL) technology. Two significant randomized studies, the Short-CUT Trial and the VICTORY Trial, compare IVL against conventional plaque modification tools such as cutting balloons and super-high-pressure non-compliant balloons. Findings presented by Dr. Suzanne J. Baron and colleagues will illuminate the mechanistic advantages of IVL’s sonic pressure waves in safely fracturing calcium deposits, facilitating stent expansion and lowering complication rates in complex plaques. Such technological refinements could herald a new standard in lesion preparation for severe calcification, improving long-term vessel patency.
The acute management of pulmonary embolism (PE) is addressed by the STORM-PE trial, which examines the efficacy of combining mechanical thrombectomy with anticoagulation versus anticoagulation alone in intermediate-to-high risk cases. Embolism-induced right ventricular failure remains a leading cause of sudden cardiovascular death, and mechanical thrombectomy devices promise rapid clot removal, potentially averting hemodynamic collapse. Dr. Robert A. Lookstein’s results will provide critical data on procedural safety and clinical benefit, informing guidelines on integrating interventional approaches into PE therapy algorithms.
Peripheral artery disease receives attention in the LIFE-BTK randomized controlled trial, focusing on infrapopliteal lesions. This study evaluates the Esprit™ below-the-knee drug-eluting resorbable scaffold’s three-year outcomes, an innovation aimed at mitigating restenosis and vessel recoil in small-caliber arteries. Dr. Sahil A. Parikh’s work explores how bioresorbable scaffolds could overcome the limitations of permanent implants by providing temporary scaffolding and drug delivery, then dissolving to restore native vessel biomechanics, a potential game-changer in critical limb ischemia treatment.
Left atrial appendage closure device thrombosis prevention strategies are tested in a novel trial comparing short-term anticoagulation versus dual antiplatelet therapy post-implantation. Given the increasing utilization of left atrial appendage closure to reduce stroke risk in atrial fibrillation, balancing thrombotic risks with bleeding complications remains a clinical conundrum. Dr. Josep Rodés-Cabau’s findings will likely influence antithrombotic regimens, optimizing device safety profiles through tailored pharmacotherapy.
Structural heart disease interventions are further showcased with real-world data on the EVOQUE valve from the STS/ACC TVT Registry. Dr. Raj Makkar presents early commercial experience elucidating valve performance, including hemodynamic results and procedural complications. Simultaneously, the TRILUMINATE pivotal trial updates the understanding of transcatheter tricuspid edge-to-edge repair (TEER), a rapidly evolving therapy addressing tricuspid regurgitation—a condition historically underserved by medical or surgical options. Dr. Jonathan G. Schwartz’s comprehensive analysis of over 800 patients offers important outcome benchmarks as the field matures.
The second day of TCT® pivots to valvular heart disease prevalence in older adults, as highlighted in the PREVUE-VALVE study. Dr. David J. Cohen elucidates epidemiological data outlining the burden and clinical impact of valvular dysfunction, emphasizing the growing need for minimally invasive valve therapies in an aging population. Long-term durability and functional outcomes of transcatheter valve platforms will be further illuminated in the PARTNER 3 trial’s seven-year follow-up, presented by Dr. Michael J. Mack. These data are pivotal to assessing lifetime management strategies for low-risk patients undergoing transcatheter aortic valve replacement (TAVR).
Innovative approaches to mitral valve intervention emerge with data from the SUMMIT Severe MAC cohort on the Tendyne transcatheter mitral valve system in patients with severe mitral annular calcification. Dr. Paul Sorajja’s report offers critical insights into device performance and functional improvements against a backdrop of complex anatomy where surgical risks are prohibitive. Complementing this, the ENCIRCLE trial evaluates a dedicated balloon-expandable valve for transseptal transcatheter mitral valve replacement, potentially broadening options for high-surgical risk patients.
Instrumentation and pharmacologic strategies remain central, as the INFINITY-SWEDEHEART randomized trial compares outcomes of patients treated with the Bioadaptor device versus contemporary drug-eluting stents, underlining advances in stent design and vascular healing. Additionally, the OCVC-BIF study contrasts drug-coated balloons with conventional balloons for bifurcation side branch lesions, relevant to optimizing complex PCI procedures. Dr. Takayuki Ishihara’s contribution deepens understanding of device efficacy in nuanced lesion subsets.
Cutting-edge biomaterial technology is featured in the IRONMAN-II randomized controlled trial evaluating a sirolimus-eluting iron bioresorbable scaffold. Unlike polymer-based systems, this iron scaffold offers unique dissolution kinetics and radial support, potentially addressing longevity and safety concerns inherent to previous bioresorbable devices. Dr. Lei Song’s two-year results may establish a new paradigm for next-generation coronary scaffolds.
Long-term clinical outcomes receive further attention in the REC-CAGEFREE I trial, investigating drug-coated balloon angioplasty with rescue stenting versus planned stenting for de novo lesions, while the NOBLE trial’s decade-spanning mortality data provide critical evidence in the debate between PCI and coronary artery bypass grafting (CABG) for unprotected left main stenosis. These results, presented by Drs. Chao Gao and Evald H. Christiansen respectively, carry substantial implications for revascularization strategy selection.
The final day of TCT® 2025 focuses sharply on advanced coronary interventions and adjunctive therapies. The PROCTOR trial, led by Dr. Ruben de Winter, compares PCI outcomes of native coronary arteries versus saphenous vein grafts in patients with prior CABG surgery, addressing a clinical scenario fraught with complex lesion morphology and higher event rates. Investigations into pharmacologic adjuncts include Shamir R. Mehta’s randomized study assessing intracoronary low-dose recombinant tissue plasminogen activator during primary PCI for STEMI patients with large thrombus burden, exploring whether thrombolytic bolstering can enhance reperfusion quality.
Further refining revascularization, the trial by Dr. Robin Nijveldt compares instantaneous wave-free ratio (iFR)-guided versus deferred cardiac magnetic resonance imaging-guided approaches in managing non-culprit lesions post-STEMI, showcasing the fusion of physiological and imaging modalities to tailor interventions. The PROMISE trial explores stratified treatments for myocardial infarction with non-obstructive coronary arteries, a challenging clinical entity requiring nuanced diagnostic and therapeutic approaches, as presented by Dr. Rocco Antonio Montone.
Device innovation continues with the TUXEDO-2 randomized trial evaluating Supraflex Cruz versus Xience stents in diabetic patients with multivessel disease, a population at heightened risk for restenosis and adverse events. Dr. Upendra Kaul supplies valuable data pertinent to stent selection in this high-risk subset. Additionally, the iCABG trial offers three-year comparative outcomes of iFR-guided versus angiography-guided CABG, relevant for surgical planning and post-operative prognosis, while the TALENT randomized trial juxtaposes Supraflex CruzTM and SYNERGYTM drug-eluting stents in multivessel disease contexts.
Expanding the armamentarium of mechanical support, Rui Wang introduces a novel percutaneous ventricular assist device (pVAD) in a prospective randomized trial against intra-aortic balloon pump (IABP) during high-risk PCI, evaluating hemodynamic augmentation capabilities and safety profiles. Concurrently, AI-enabled ECG interpretation in STEMI, analyzed from a U.S.-based multicenter registry led by Dr. Timothy D. Henry, reflects the growing role of artificial intelligence in accelerating diagnosis and streamlining emergency workflows.
Finally, the INVEST CTO single-arm study by Anja Oksnes examines the safety and effectiveness of a planned investment procedure in managing high-risk chronic total occlusions, aiming to optimize procedural success while minimizing complications in one of the most technically challenging coronary interventions.
Collectively, the extensive portfolio of studies presented at TCT® 2025 underscores a vibrant and evolving field where interventional cardiology continues to integrate cutting-edge technology, sophisticated imaging, and precision medicine. The symposium’s comprehensive coverage from coronary to structural heart disease, and from device innovation to pharmacologic adjuncts, ensures that clinicians remain at the frontier of combating cardiovascular morbidity and mortality globally.
Subject of Research: Interventional Cardiovascular Medicine and Late-Breaking Clinical Trials at TCT® 2025
Article Title: Groundbreaking Innovations and Clinical Trial Breakthroughs Unveiled at TCT® 2025
News Publication Date: August 27, 2025
Web References:
https://www.tctconference.com/late-breaking-research
https://www.tctconference.com/press-registration
https://x.com/crfheart
http://www.crf.org
http://www.tctconference.com
Keywords: Cardiovascular disorders, Interventional cardiology, Drug-eluting stents, Intravascular lithotripsy, Pulmonary embolism, Bioresorbable scaffold, Structural heart disease, Transcatheter valve replacement, Myocardial infarction, Percutaneous coronary intervention, Artificial intelligence, Coronary artery disease
Tags: advancements in cardiovascular interventioncardiovascular research foundationdrug-eluting stent comparisoninterventional cardiovascular medicinelate-breaking clinical trialsminimally invasive proceduresnext-generation pharmaceuticalsnovel therapies and devicespercutaneous coronary interventionsirolimus-eluting balloonTCT 2025 symposiumtherapeutic efficacy in cardiovascular disease
