WASHINGTON – For treating de novo coronary lesions in vessels smaller than 2.75 mm, drug coated balloon angioplasty is as safe and may be as effective as drug-eluting stents, according to a multicenter randomized trial presented as a late-breaker at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The aim of PCI [percutaneous coronary intervention] without leaving any metal behind seems to be feasible and safe with drug coated balloons,” reported Victor A. Jimenez Diaz, MD, of the department of cardiology at University Hospital, Vigo, Spain.
De novo lesions in small coronary vessels are a clinical challenge, according to Dr. Jimenez Diaz. These are associated with relatively high rates of restenosis. They are also associated with a vessel thrombosis rate of 1% within 6 months, and a small but significant risk of major adverse cardiac events, variably estimated to range between 6% and 10% at 1 year. There is no uniformly accepted standard for treatment.In this study, 94 patients with de novo coronary lesions in small diameter vessels were randomized to treatment with a paclitaxel drug coated balloon (DCB) (IN.PACT Falcon, Medtronic) or a zotarolimus drug-eluting stent (DES) (Resolute Integrity, Medtronic). Lesions in vessels between 2.0 and 2.75 mm in diameter were eligible; 137 lesions were treated in a study with seven participating centers in Spain.