The Cardiovascular Research Foundation (CRF) has announced the late-breaking clinical trials and science to be presented at TCT 2024, its annual scientific symposium, scheduled for October 27-30 in Washington, D.C. This year's TCT will feature 25 studies focused on innovative approaches to treating and preventing cardiovascular disease.
Aortic Stenosis and Valve Interventions
Several trials will address aortic stenosis and valve interventions. The EARLY TAVR trial investigates transcatheter aortic valve replacement (TAVR) for asymptomatic severe aortic stenosis. Currently, guidelines recommend intervention only after symptom onset. "These trials could potentially change how we approach aortic stenosis treatment," said a lead investigator. The EVOLVED trial examines early intervention in asymptomatic severe aortic stenosis patients with left ventricular myocardial fibrosis. TAVR UNLOAD assesses TAVR in systolic heart failure patients with moderate aortic stenosis.
The Co-STAR trial evaluates colchicine in patients with aortic stenosis undergoing TAVR. Additionally, the ACCESS TAVI trial compares strategies for vascular access closure after TAVR, while the PROTECTED TAVR: US Subgroup focuses on cerebral embolic protection during TAVR within the US cohort. RHEIA/PARTNER Pooled Analysis in Women presents a pooled analysis of the RHEIA and PARTNER 3 trials, comparing transcatheter vs. surgical aortic valve replacement in women. ALIGN-AR 2 Year reports two-year outcomes of TAVR with JenaValve Trilogy™ in high surgical risk patients with moderate-to-severe or severe native aortic regurgitation.
Coronary Artery Disease and Intervention
In the realm of coronary artery disease, the DCB-BIF trial compares noncompliant balloon with drug-coated balloon angioplasty for side branch stenosis after provisional stenting for true coronary bifurcation lesions. The HELP PCI trial examines early heparin administration at first medical contact versus in the cath lab for STEMI patients undergoing primary percutaneous coronary intervention. DRAMI compares puncture success rates between distal radial access and transradial access in STEMI patients.
The INFINITY-SWEDEHEART Complex PCI trial presents one-year clinical outcomes among patients with complex lesion subsets treated with DynamX bioadaptor compared to a contemporary drug-eluting stent. CONFIRM-2 utilizes artificial intelligence for quantitative CT assessment of atherosclerosis and major adverse events. ECLIPSE compares orbital atherectomy vs. conventional balloon angioplasty in severely calcified coronary arteries prior to DES implantation. FAVOR III Europe assesses quantitative flow ratio or fractional flow reserve for guiding coronary revascularization. FLASH evaluates artificial intelligence-based fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation.
Myocardial Infarction and Anti-inflammatory Therapies
CLEAR SYNERGY (OASIS 9) presents results from a 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone versus placebo in patients with myocardial infarction. "This trial could provide insights into the role of anti-inflammatory therapies post-MI," explained a trial investigator.
Other Cardiovascular Conditions
PEERLESS compares large-bore mechanical thrombectomy vs catheter-directed thrombolysis for intermediate-risk pulmonary embolism. SIRONA compares sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery. TRISCEND II compares transcatheter valve replacement vs optimal medical therapy for severe tricuspid regurgitation. CLEAR-IE examines outcomes of percutaneous mechanical aspiration in right-sided infective endocarditis. CLASP IID 2 Year RCT and Registry reports two-year outcomes of transcatheter edge-to-edge repair for degenerative mitral regurgitation. MATTERHORN presents results from a subgroup analysis on atrial mitral regurgitation.
TARGET IV assesses the Firehawk® rapamycin-eluting coronary stent system, while TARGET DAPT examines 3-month versus 12-month dual antiplatelet therapy after Firehawk® stent implantation.