Cutting balloon predilation prior to implantation of the Abluminus sirolimus-eluting stent did not improve minimum stent area or reduce neointimal hyperplasia compared with standard balloon predilation, according to new late-breaking trial data. The data, presented at a late-breaking clinical trials session on Saturday, March 7, at the Cardiovascular Research Technologies (CRT) 2026 meeting in Washington, D.C., addressed an open question around lesion preparation strategy for the Abluminus DES (ASES, Envision Scientific, India), a cobalt-chromium sirolimus-eluting stent with a biodegradable abluminal polymer coating on both stent and balloon that has shown favorable safety and efficacy in early studies. Speaking at CRT 2026, Jorge Sanz Sanchez, MD, PhD, of the University and Polytechnic La Fe Hospital in Valencia, Spain, said that because lesion preparation is key to drug uptake, it remained uncertain whether plaque modification with a cutting balloon before ASES implantation would enhance outcomes. The trial reported no additional benefit of routine cutting balloon use over standard predilation in patients with de novo coronary artery disease undergoing percutaneous coronary intervention (PCI). The secondary endpoint of acute procedural success, stent apposition and 12-month clinical outcomes were also similar between the two approaches, said Dr. Sanz Sanchez. Study details CUT DRESS is a prospective, multicenter, randomized trial enrolling 96 patients with de novo coronary artery disease, the investigators reported. Patients were randomized 1:1 to cutting balloon (CB) or standard balloon (SB) predilation, followed by ASES implantation under optical coherence tomography (OCT) guidance. Angiographic surveillance and OCT imaging were performed at 9 months, with an independent core lab analyzing the OCT data, Dr. Sanz Sanchez said. The primary endpoint was post-PCI minimum stent area (MSA), while the key secondary powered endpoint was neointimal hyperplasia percentage at 9 months. Clinical follow-up was performed at 12 months. Preliminary data included 80 patients who completed clinical follow-up and 35 with available OCT analysis, according to the researchers. Baseline and procedural characteristics were balanced between groups. Post-PCI MSA was 5.32 ± 1.85 mm² in the CB group compared with 5.83 ± 1.94 mm² with SB (95% CI: -0.5 to 1.7; p=0.423), the investigators found. At 9 months, neointimal hyperplasia was 12.55 ± 8.97% in the CB group versus 10.42 ± 9.43% with SB (95% CI: -8.5 to 4.2; p=0.934). Acute procedural success and malapposition rates were comparable. At 12 months, clinical event rates were low and similar across groups, Dr. Sanz Sanchez noted, adding that all-cause death occurred in 2.8% of both groups (p=0.933), target lesion revascularization was also 2.8% in each arm (p=0.933), and stent thrombosis occurred in 2.9% of CB patients versus 0% with SB (p=0.285). Image Credit: Bailey G. Salimes, CRTonline.org Image Caption: Jorge Sanz Sanchez, MD, PhD, of the University and Polytechnic La Fe Hospital in Valencia, Spain, presents his late-breaking clinical trial on Saturday, March 7, 2026, at Cardiovascular Research Technologies (CRT) in Washington, D.C.