Efficacy and safety of drug-coated balloons in the treatment of de novo coronary lesions in very small vessels: a prospective, multicenter, single-arm trial

Background: Evidence of the use of drug-coated balloons (DCB) in de novo large or small coronary lesions and in-stent restenosis has accumulated over the past years. Due to their anatomical peculiarity, the treatment of very small vessels (VSV) (lumen diameter <2 mm) is still a controversial issue. Studies that examine the use of DCB in VSV are limited. We investigated the efficacy and safety of using DCBs for the de novo coronary lesions in VSV undergoing percutaneous coronary intervention (PCI). Methods: In this prospective, single-arm study, we enrolled adult patients with coronary artery disease from six centers in China. A total of 29 patients had VSV with a target lesion stenosis >= 70% were included. All patients were treated with DCB. The primary endpoint was late lumen loss (LLL) at 9 months of followup. The secondary endpoints were major adverse cardiac events including target lesion revascularization, death, or myocardial infarction at 9 months of follow-up. Results: Twenty-nine eligible patients with VSV were enrolled between November 2019 to May 2020. Angiographic and clinical follow-up were completed at 9 months in 18 (56.25%) patients (7 patients refused to final angiography; 2 failed to finish DCB angioplasty; 1 patient request; 1 other causes of death). The mean diameter of the reference vessel of the target lesion was 1.71 +/- 0.27 mm, the minimum lumen diameter (MLD) of the target lesion before operation was 0.31 +/- 0.24 mm, the average LLL of the target lesion was 0.13 +/- 0.28 mm, and the MLD of the target vessel immediately after operation was (1.19 +/- 0.20 mm) and at the 9-month follow-up (1.06 +/- 0.31 mm) were significantly higher than those before operation (P=0.043). One patient (5.56%) underwent revascularization. No myocardial infarction or death occurred during follow-up after treatment with DCBs. Conclusions: DCB can be a safe and effective alternative in the treatment of de novo coronary lesions in VSV.