Abstract:Aim To evaluate the efficacy and safety of paclitaxel-coated balloon (PCB) in the treatment of primary macroangiopathy of coronary artery (vessel diameter≥2.8 mm). Methods A prospective, randomized and controlled study was conducted in 100 consecutive patients with coronary heart disease who underwent coronary intervention in our hospital from January 2013 to December 2016. The patients were randomly divided into PCB group and drug-eluting stent (DES) group, with 50 cases in each group. The basic clinical data, the results of immediate coronary intervention and re-examination of angiography, and the long-term incidence of major adverse cardiovascular events were compared between the two groups. Results (1)There were no significant differences in age, blood pressure, blood lipid, smoking, past hypertension, diabetes mellitus and PCI history between the two groups (P>0.05). (2)The ratio of single coronary artery lesion in PCB group was lower than that in DES group (60.0% vs 70.0%, P=0.02). There was no significant difference in the ratio of double vessel lesions, three vessel lesions and left main vessel lesions between the two groups (P>0.05). (3)There was no significant difference in preoperative minimal lumen diameter (MLD) between PCB group and DES group (P<0.05). The MLD of PCB group was smaller than that of DES group immediately after operation, and the MLD of follow-up was larger than that of DES group (P<0.05). There was no significant difference in late lumen loss between the two groups. (4)There was no significant difference in the incidence of major adverse cardiovascular events between PCB group and DES group. There were no deaths or recurrent acute myocardial infarction events in both groups during the follow-up period. Conclusion PCB is safe and effective in the treatment of primary macroangiopathy of coronary artery, and the long-term positive vascular remodeling is better than DES to some extent.