The use of drug-eluting resorbable scaffolds in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease; comparison of the AGENT drug-coated balloon (DCB) with conventional balloon angioplasty for in-stent restonisis (ISR); use of pressure-controlled intermittent coronary sinus occlusion (PiCSO) in acute myocardial infarction (MI); and potential benefits of ticagrelor monotherapy after <1 month of DAPT in patients with acute coronary syndrome (ACS), were the subjects of new late-breaking clinical science presented Oct. 25 during TCT 2023.

In the LIFE-BTK trial, simultaneously published in the New England Journal of Medicine, the use of an everolimus-eluting resorbable scaffold in patients with CLTI due to infrapopliteal artery disease was superior to angioplasty in terms of freedom from amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion at one year. The use of the scaffold was noninferior to angioplasty with respect to freedom from major adverse limb events at six months and from perioperative death. The multicenter trial involved 261 patients who were randomly assigned in a 2:1 ratio to receive treatment with the everolimus-eluting resorbable scaffold or angioplasty.

In the AGENT IDE trial, researchers compared the safety and efficacy of the AGENT DCB to conventional balloon angioplasty in patients with ISR. Overall findings showed AGENT DCB was superior to conventional balloon angioplasty for the primary endpoint of target lesion failure at one-year (17.9% vs. 28.7%; p=0.006). These differences were driven by ~50% reductions in rates of target lesion revascularization and target vessel MI in the AGENT vs. conventional balloon angioplasty arms. In presenting the findings, Robert W. Yeh, MD, MSc, MBA, FACC, noted that AGENT DCB is an U.S. Food and Drug Administration-designated breakthrough device and these trial findings will be the primary evidence used to support FDA approval. "Given the markedly superiority over conventional balloon angioplasty at reducing recurrent events, the AGENT DCB is likely to become an important new treatment option for patients with coronary restenosis in the US," he said.

Findings from the T-PASS trial, simultaneously published in Circulation, "provide evidence that stopping aspirin within one month after implantation of drug-eluting stents for ticagrelor monotherapy is a reasonable alternative to 12-month DAPT" with respect to adverse cardiovascular and bleeding events in patients with ACS, according to Myeong-Ki Hong, MD, PhD. Overall findings found <1 month of DAPT followed by ticagrelor monotherapy met a noninferiority threshold and provided evidence of superiority to 12 months of ticagrelor-based DAPT for a one-year composite outcome of death, myocardial infarction, stent thrombosis, stroke, and major bleeding, primarily due to a significant reduction in bleeding events.

In presenting the findings from PICSO-AMI-I, Giovanni Luigi De Maria, MD, PhD, said PiCSO therapy used in conjunction with primary PCI did not reduce myocardial infarct size in patients with anterior STEMI. "Randomized trials like PiCSO-AMI-I play a crucial role in advancing our understanding of how to minimize infarct size," said De Maria. "These results contribute to the ongoing body of research, offering valuable insight and stressing the importance of refining patient selection to better define the phenotype of STEMI patients who can benefit from additional therapies on top of primary PCI."