Efficacy and safety of the paclitaxel drug-coated balloon angioplasty for the treatment of coronary small vessel disease: a prospective, multicenter, randomized clinical trial

The optimal revascularization strategy for coronary small vessel disease remains controversial due to limited lumen gain and high restenosis risk associated with stent implantation. Drug-coated balloon may offer an alternative by delivering antiproliferative drugs without leaving a permanent implant. This study aimed to evaluate the efficacy and safety of a paclitaxel-coated balloon developed by Hangzhou Revita Medical Technology Co., Ltd. for the treatment of coronary small vessel disease and very small vessel disease. This prospective, multicenter, randomized controlled trial enrolled 216 patients with reference vessel diameters between 1.5 and 2.5 mm at eight centers in China. Participants were randomly assigned (1:1) to treatment with a paclitaxel-coated balloon (Drug coated balloon group, n = 109) or a conventional balloon (Uncoated balloon group, n = 107). Patients with RVD < 2.0 mm were defined as the very small vessel disease (VSVD). The primary endpoint was in-lesion late lumen loss at 9 months. Secondary endpoints included minimal lumen diameter, percent diameter stenosis, binary restenosis, and device-oriented major adverse cardiovascular events. At 9 months, angiographic follow-up was completed in 176 patients. The drug coated balloon group showed significantly lower in-lesion LLL compared with the uncoated balloon group (0.15 ± 0.34 mm vs. 0.36 ± 0.43 mm, p < 0.001), larger MLD (1.39 ± 0.41 mm vs. 1.13 ± 0.48 mm, p < 0.001), and reduced DS% (28.52 ± 19.11% vs. 42.42 ± 21.72%, p < 0.001). Binary restenosis occurred less frequently in the drug coated balloon group (9.8% vs. 31.0%, p < 0.001). Clinical outcomes were comparable between groups, with no deaths and similar DO-MACE rates (1.8% vs. 2.8%, p = 0.591). The analysis in the very small vessels disease cohort (RVD < 2.0 mm) demonstrated consistent angiographic and clinical benefits. Paclitaxel-coated balloon is safe and effective for the treatment of de novo coronary small vessel lesions, providing superior angiographic outcomes and comparable clinical safety relative to conventional balloon. The efficacy of DCB was consistent in very small vessels (RVD < 2.0 mm). ChiCTR2200056430, February 6, 2022 (Retrospectively registered).