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

doi:10.3969/j.issn.2095-4344.2308

Abstract

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.

Key words:

drug coated balloon, drug eluting stent, coronary heart disease, small vascular disease, the elderly, diabetes mellitus, percutaneous coronary intervention

CLC Number:

Zheng Haijun, Jin Hui, Cui Hongling, Zhu Yakun, Zeng Hui, Han Fengjie, Qiu Cuiting, Liu Jing.

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 [J]. Chinese Journal of Tissue Engineering Research, 2020, 24(28): 4573-4579.

Figures/Tables 7

References

[1] 翟东东,高炬,张萌,等.药物涂层球囊在冠状动脉小血管病变中的应用观察[J].中国循证心血管医学杂志,2019,11(4):477-479.

[2] TURIN TC, OKAMURA T, RUMANA N, et al. Diabetes and lifetime risk of coronary heart disease.Prim Care Diabetes. 2017;11(5):461-466.

[3] 林立龙,马煜盛,林子祥,等.高密度脂蛋白颗粒､C反应蛋白在冠心病合并2型糖尿病人群中的临床意义[J].实用医学杂志,2019,35(12):1920-1925.

[4] VOS NS, FAGEL ND, AMOROSO G, et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.JACC Cardiovasc Interv. 2019; 12(17):1691-1699.

[5] 谢江波,陈晖,温燕华,等.药物涂层球囊在冠状动脉小血管病变中的疗效[J].实用医学杂志,2019,35(7):1092-1095.

[6] 中华医学会糖尿病分会.中国2型糖尿病防治指南(2013年版)[J].中国糖尿病杂志,2014,22(8):2-42.

[7] 柯元南,陈纪林.不稳定性心绞痛和非ST段抬高心肌梗死诊断与治疗指南[J].中华心血管病杂志,2007,35(4):295-304.

[8] 薛宪骏,钱钧,刘文武,等.药物涂层球囊对冠状动脉小血管原发病变的疗效[J].国际心血管病杂志,2018,45(4):245-247.

[9] CASSESE S, XU B, HABARA S, et al. Incidence and predictors of reCurrent restenosis after drug-coated balloon Angioplasty for Restenosis of a drUg-eluting Stent: The ICARUS Cooperation.Rev Esp Cardiol (Engl Ed).2018;71(08):620-627.

[10] SAKAMOTO Y, YAMAWAKI M, ARAKI M, et al. Comparison of 12-month angiographic outcomes between repeat drug-eluting stent implantation and drug-coated balloon treatment for restenotic lesion caused by stent fracture.Heart Vessels.2019;34(10):1589-1594.

[11] CORTESE B, D'ASCENZO F, FETIVEAU R, et a1. Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE.J Cardiovasc Med(Hagerstown).2018;19(5):247-252.

[12] JEGER RV, FARAH A, OHLOW MA, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2) :an open-label randomised non-inferiority trial.Lancet.2018;392 (10150):849-856.

[13] TANG Y, QIAO S, SU X, et al. Drug-C oated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease:The RESTORE SVD China Randomized Trial.JACC Cardiovasc Interv. 2018;11(23): 2381-2392.

[14] 曾紫微,周竹花,刘继文,等.2型糖尿病与冠脉支架术后再狭窄的相关性研究[J].现代诊断与治疗,2016,27(23):4536-4538.

[15] GODOY LC, RAO V, FARKOUH ME. Diabetes and multivessel disease: coronary artery bypass grafting remains king.Curr Opin Cardiol.2018;33(5):551-557.

[16] HU L, DAI SC, LUAN X, et al. Dysfunction and Therapeutic Potential of Endothelial Progenitor Cells in Diabetes Mellitus.J Clin Med Res. 2018; 10(10):752-757.

[17] GIUSTINO G, MEHRAN R, SERRUYS PW, et al. Left Main Revascularization With PCI or CABG in Patients With Chronic Kidney Disease:EXCEL Trial.J Am Coll Cardiol.2018;72(7):754-765.

[18] FALLATAH R, ELASFAR A, AMOUDI O, et al. Endovascular repair of severe aortic coarctation,transcatheter aortic valve replacement for severe aortic stenosis,and percutaneous coronary intervention in an elderly patient with long term follow-up.J Saudi Heart Assoc. 2018; 30(3):271-275.

[19] KUMAR A, SHARIFF M. Trial sequential analysis of studies comparing the frequency of target-vessel revascularization with drug-coated balloons as compared with second-generation drug-eluting stents in coronary in-stent restenosis: Have we generated enough evidence in the field? Indian Heart J.2019;71(3):288-290.

[20] ABELLAS-SEQUEIROS RA, BENEZET J, AGARRADO LUNA A, et al. Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels: initial experience with the Essential paclitaxel-coated balloon.Coron Artery Dis.2018;29(06): 477-481.

[21] 杨淦,卜军,何奔.药物涂层球囊在冠状动脉小血管病变中的应用[J].上海交通大学学报(医学版),2018,38(6):695-698.

[22] YU X, JI F, XU F, et al. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol.2019;108(3):234-243.

[23] RONCALLI J, GODIN M, BOUGHALEM K, et al. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial).J Invasive Cardiol.2019;31(4):94-100.

[24] SCHNEIDER PA, LAIRD JR, DOROS G, et al. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon.J Am Coll Cardiol. 2019;73(20):2550-2563.

[25] NEUMANN FJ, SOUSA-UVA M, AHLSSON A, et al. 2018 ESC/EACTS guidelines on myocardial revascularization:the task force on myocardial revascularization of the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association for Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J.2019;40(2):87-165.

[26] 陈韵岱,王建安,刘斌,等.药物涂层球囊临床应用中国专家共识[J].中国介入心脏病学杂志,2016,24(2):61-67.