SAN FRANCISCO – A paclitaxel-coated balloon showed superior efficacy to balloon angioplasty in treating coronary in-stent restenosis (ISR) in a pivotal trial. Robert Yeh, MD, of Beth Israel Deaconess Medical Center, Boston, presented these results during a late-breaking trial session Wednesday at Transcatheter Cardiovascular Therapeutics (TCT) 2023. Despite advances in coronary stents over the years, ISR is still common. Additional layers of stent or balloon angioplasty are often used to treat ISR. Drug-coated balloons (DCBs) can deliver antiproliferative drug without leaving additional metal layers behind. Currently no coronary DCBs are approved in the U.S. The AGENT IDE trial is a pivotal trial randomized patients with coronary ISR lesions in a 2-to-1 fashion to receive the AGENT paclitaxel-coated balloon (n=321) or balloon angioplasty (n=159). Patients were excluded if they had complex presentations including recent large myocardial infarction (MI) or complex coronary anatomy. Randomization was conducted after the target lesion was successfully predilated. The AGENT DCB has received Breakthrough Device approval from the U.S. Food and Drug Administration. The trial is sponsored by Boston Scientific Corp., the manufacturer of the study device. The primary endpoint was target lesion failure (TLF) at 1 year, defined as a composite of recurrent ISR, target vessel MI or cardiac death. At baseline, the patients’ mean age was 68.6 years in the DCB group and 67.5 years in the angioplasty group; 26.8% of patients in the DCB group were female, as were 27% in the angioplasty group, and most patients were Caucasian (73.8% DCB and 76.1% balloon angioplasty). About half of the patients in each group had diabetes, about 43% in both groups had multiple stent layers, and approximately three-fourths of patients in each group underwent intravascular imaging during the procedure. More than half of patients had stable angina as the indication for the index procedure, with nearly 40% having acute coronary syndrome. At 1 year, 17.9% of patients in the DCB group experienced TLF, as did 28.7% in the balloon angioplasty group (difference: -10.7 percentage points; 95% confidence interval [CI]: -19.2 to -2.3 percentage points; p for superiority = 0.0063). The DCB group showed roughly 50% reduction in both target lesion revascularization (12.4% vs. 24.0%; hazard ratio [HR]: 0.49; 95% CI: 0.31-0.78; p=0.002) and target vessel MI (6.4% vs. 12.3%; HR: 0.51; 95% CI: 0.27-0.95; p=0.03) at 1 year. Finally, no stent thrombosis occurred in the DCB group (0% vs. 3.9% angioplasty; p=0.001). “Given the marked 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 U.S.,” Yeh concluded. Image Caption: Image Caption: Robert Yeh, MD, speaks during a news conference Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Image Credit: Jason Wermers/CRTonline.org