The Cardiovascular Research Foundation (CRF) has unveiled the late-breaking clinical trials scheduled for presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place from October 23 to 26 in San Francisco. TCT is renowned for showcasing groundbreaking research in interventional cardiovascular medicine, influencing patient care and the approach of physicians to heart disease treatment.
Among the event's highlights are three late-breaking trial sessions, focusing on studies anticipated to significantly influence the field of interventional cardiology and structural heart interventions.
Late-Breaking Clinical Trials: Session I, in Collaboration with the New England Journal of Medicine
Tuesday, Oct. 24, 11 a.m. — 12:28 p.m., Innovation & Clinical Science Theater, Hall B, Exhibition Level, Moscone South
PARTNER 3 Low-Risk: Five-year clinical and echocardiographic outcomes from the PARTNER 3 Low-Risk Randomized Trial. Presented by Martin Leon. This trial aimed to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis at low operative risk for standard aortic valve replacements. (CT: NCT02675114)
EVOLUT Low Risk: Four-year outcomes from the EVOLUT Low Risk Trial. Presented by Michael Reardon. This trial aimed to evaluate the safety and effectiveness of the Medtronic TAVR system in patients with bicuspid aortic anatomies and severe aortic stenosis, who were at low risk for SAVR. (CT: NCT03635424)
WATCH TAVR: Safety and efficacy of left atrial appendage (LAA) occlusion at the time of transcatheter aortic valve replacement. Presented by Samir Kapadia. This trial aimed to evaluate the safety and effectiveness of left atrial appendage occlusion with the WATCHMAN Device (Boston Scientific) in the prevention of stroke and bleeding in patients with AF who are undergoing a TAVR procedure. (CT: NCT03173534)
ALIGN-AR: Initial outcomes of the JenaValve Trilogy transcatheter aortic valve replacement system in high-risk patients with symptomatic severe native aortic regurgitation. Presented by Vinod Thourani. ALIGN-AR aims to examine the use of TAVR with the Jenavalve pericardial TAVR system, which is designed to help treat severe aortic regurgitation. (CT: NCT04415047)
Late-Breaking Clinical Trials: Session II, in Collaboration with The Lancet
Wednesday, Oct. 25, 11 a.m. — 12:28 p.m., Innovation & Clinical Science Theater, Hall B, Exhibition Level, Moscone South
LIFE-BTK: Primary outcomes of the Esprit BTK drug-eluting resorbable scaffold for the treatment of infrapopliteal lesions. Presented by Ramon Varcoe. This trial aimed to evaluate the safety and efficacy of the Esprit BTK system for the treatment of narrowed Infrapopliteal lesions. (CT: NCT04227899)
AGENT IDE: Primary outcomes of a pivotal multicenter randomized trial comparing the AGENT paclitaxel-coated balloon with conventional balloon angioplasty for in-stent restenosis. Presented by Robert Yeh. This study aimed to assess the safety and effectiveness of the Agent paclitaxel coated balloon catheter as compared to balloon angioplasty in patients with in-stent restenosis of a previously treated lesion. (CT: NCT04647253)
T-PASS: Less than 1-month dual antiplatelet therapy followed by ticagrelor monotherapy after coronary drug-eluting stent implantation for acute coronary syndrome. Presented by Myeong-Ki Hong. This trial aims to evaluate the effectiveness of ticagrelor monotherapy in the prevention of thromboembolic events without aspirin post-PCI in patients with acute coronary syndrome. (CT: NCT03797651)
PICSO-AMI-I: Pressure-controlled intermittent coronary sinus occlusion (PiCSO) in acute myocardial infarction. Presented by Giovanni Luigi De Maria. PICSO-AMI-I aims to assess the safety and feasibility of pressure-controlled intermittent coronary sinus occlusion (PiCSO) therapy in patients with ST elevation inferior wall myocardial infarction with TIMI 0 or 1 undergoing PCI, as compared to standard PCI. (CT: NCT04958421)
TCT Late-Breaking Clinical Trials: Session III, in Collaboration with the Journal of the American Medical Association
Thursday, Oct. 26, 11 a.m. — 12:30 p.m.
Innovation & Clinical Science Theater, Hall B, Exhibition Level, Moscone South
TRISCEND II: A randomized trial of transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. Presented by Susheel Kodali. TRISCEND II aims to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system compared to optimal medical therapy alone in the treatment of patients with severe tricuspid regurgitation. (CT: NCT04482062)
TRILUMINATE: Quality of life after transcatheter tricuspid-valve repair vs. medical therapy in patients with severe tricuspid regurgitation. Presented by Suzanne Arnold. TRILUMINATE studied the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. (CT: NCT03904147)
VIVA: Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis and small aortic annuli. Presented by Josep Rodés-Cabau. This trial aimed to compare the hemodynamic performance and clinical outcomes between TAVR and SAVR in patients with severe aortic stenosis and small aortic annuli. (CT: NCT03383445)
CLASP IID Trial and Complex Anatomy Registry: One year outcomes from a randomized comparison of transcatheter edge-to-edge repair systems for degenerative mitral regurgitation. Presented by Robert Smith and Firas Zahr. This trial aimed to establish the safety and effectiveness od the Edwards PASCAL transcatheter valve repair system in patients with degenerative mitral valve regurgitation at risk for mitral valve surgery, and in patient with functional mitral regurgitation on guideline-directed medical therapy. (CT: NCT03706833)