Safety of drug-coated balloon versus drug-eluting stents in the treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease in older adult patients / 中国组织工程研究

ABSTRACT

BACKGROUND: It has been found that drug-coated balloons can reduce the loss of lumen in the advanced stage of coronary small-vessel disease, and the incidence of major adverse cardiovascular events at 6 months after surgery with drug-coated balloons is similar to that of drug-eluting stents. However, clinical studies on the efficacy of drug-eluting stents in older adult patients with type 2 diabetes mellitus complicated by coronary artery small vessel disease are still lacking. OBJECTIVE: To investigate the efficacy and safety of drug-coated balloon versus drug-eluting stent in the treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease in older adult patients. METHODS: A total of 122 older adult patients with type 2 diabetes mellitus complicated by coronary artery small vessel disease who received treatment in Jiaozuo People’s Hospital between January 2016 and September 2018 were included in this study. These patients were randomly divided into a drug-eluting stent group (n=62) and a drug-coated balloon group (n=60). Patients in both groups underwent coronary artery predilation with a semi-compliant balloon, followed by implantation of corresponding stents. Selective quantitative coronary angiography was performed before surgery, immediately, 6 months and 12 months after surgery. The minimum lumen diameter, residual stenosis, lumen increase and late lumen loss of target lesions were observed in the two groups. At 6 and 12 months after surgery, major adverse cardiovascular events and bleeding events were followed up. This study was approved by the Medical Ethics Committee of Jiaozuo People’s Hospital, China (approval No. 201503). RESULTS AND CONCLUSION: (1) The success rate of surgery in the drug-coated balloon group was significantly higher than that in the drug-eluting group (P=0.028). (2) Immediately after surgery, the minimum lumen diameter and lumen increase in the drug-coated balloon group were less than those in the drug-eluting stent group (both P < 0.01). The residual stenosis in the drug-coated balloon group was significantly greater than that in the drug-eluting stent group (P < 0.01). (3) At 6 months after surgery, late lumen loss of target vessels in the drug-coated balloon group was smaller than that in the drug-eluting stent group (P < 0.001). The rates of target vessel revascularization and major adverse cardiovascular events in the drug-coated balloon group were lower than those in the drug-eluting stent group (P=0.028, 0.010). (4) At 12 months after surgery, the minimum lumen diameter in the drug-coated balloon group was larger than that in the drug-eluting stent group (P=0.033). The residual stenosis and late lumen loss in the drug-coated balloon group were lower than those in the drug-eluting stent group (P=0.008, 0.002, 0.019). (5) These results suggest that drug-coated balloon for treatment of type 2 diabetes mellitus complicated by coronary artery small vessel disease is simple and easy to operate, with a high surgical success rate. Drug-coated balloon can reduce residual stenosis degree and late lumen loss, decrease the revascularization rate of target vessels, and reduce the incidences of major adverse cardiovascular disease and bleeding events. The clinical prognosis of drug-coated balloon is superior to that of drug-eluting stent.