| Background:Before the application of drug-coated balloons(DCB),the use of drugeluting stents(DES)represented an important stage in the treatment of coronary artery disease.However,DCB offers a completely new treatment concept compared to DES.With the new technology it has developed,DCB delivers proliferation-inhibiting drugs to the vessel wall without leaving foreign bodies in the coronary artery lumen.Instead,this technique of not leaving the implant in place reduces the risk of late stent failure,shortens the course of long-term antiplatelet therapy that would otherwise be required,and potentially reduces the associated bleeding complications.Therefore,DCB was initially considered for the treatment of in-stent restenosis(ISR)based on its design concept.Although next-generation DES remains the current common treatment strategy in percutaneous coronary intervention(PCI),the field of application of DCB is gradually increasing worldwide.Findings from several national and international studies suggest that DCB has equally superior safety and efficacy in other clinical situations than ISR,such as in other coronary vascular lesions:bifurcation lesions,small vessel de-novo coronary lesions,and patients with high bleeding risk.As an independent risk factor for coronary heart disease,diabetes exposes patients to a more severe systemic inflammatory burden and the extent of atherosclerosis spread and progression.Patients with diabetes have a greater risk of myocardial infarction than non-diabetic patients,and coronary atherosclerotic lesions in patients with combined diabetes are more complex and specific,manifesting mostly as:small vessel de-novo coronary lesions,bifurcation lesions,multi-branch lesions,and diffuse lesions.Also,the long-term effects of higher blood glucose concentrations lead to a higher incidence of adverse cardiovascular events and ISR.Therefore,the efficacy and prognosis of DCB for the treatment of patients with coronary artery lesions in combination with diabetes have been widely noted.The aim of this study is to investigate the impact of diabetes and its glycemic control on the clinical prognosis of patients with de-novo coronary lesions treated with DCB,and to provide a reference for clinical practice in the treatment of this special population.Purpose:To investigate the impact of glycemic control in diabetes on the clinical prognosis of patients treated with drug-coated balloons(DCB)for de-novo coronary lesions.Methods:Two hundred and forty-four patients with de novo coronary artery lesions who were hospitalized and treated with DCB intervention in Qingdao Municipal Hospital from August 2019 to November 2021 were enrolled as study subjects,and patients were divided into the no-diabetes group,the diabetic well-controlled glycemic group(HbAlC<6.5%)and the diabetic glycemic.The poorly controlled group(HbA1C≥6.5%)was divided into three groups.The primary endpoints for the 1-year follow-up were major adverse cardiovascular events(MACE)and target lesion failure(TLF).The clinical prognostic impact of diabetes and its glycemic control on patients with de novo lesions treated with DCB was analyzed.Results:Among 244 patients with de novo coronary artery disease treated with DCB,124(50.82%)were in the group without diabetes,39(15.98%)in the group with good diabetic glycemic control(HbA1C<6.5%),and 81(33.20%)in the group with poor diabetic glycemic control(HbA1C≥6.5%).1-year follow-up showed that the incidence of MACE was significantly higher in the group with poor diabetic glycemic control than in the group without diabetes(16.94%vs.15.38%vs.40.47%,P<0.001).The 1-year follow-up results showed that the incidence of MACE was significantly higher in the diabetic poor glycemic control group than in the diabetic good glycemic control group and the no-diabetes group(16.94%vs.15.38%vs.40.47%,P<0.001);the incidence of TLF was higher in the diabetic poor glycemic control group than in the no-diabetes group(2.42%vs.9.88%,P=0.032).Patients with a history of diabetes were divided into 62 patients(52.10%)in the aspirin+ticagrelor group and 57 patients(47.90%)in the aspirin+clopidogrel group according to the type of dual anti-drug they were taking postoperatively.Comparing the clinical prognostic indicators between the two groups,the incidence of cardiac death(0.00%vs.7.02%,P=0.044)and acute heart failure(0.00%vs.10.53%,P=0.009)was lower in the ticagrelor group than in the clopidogrel group.Logistic regression analysis of the occurrence of MACE in patients with de-novo lesions in combination with diabetes mellitus treated with DCB showed:age[OR=3.083,95%CI(1.225-7.759),P=0.017];history of hypertension[OR=2.229,95%CI(1.225-7.759),P=0.178]);glycemic control[OR=4.361,95%CI(1.499-12.689),P=0.007];history of PCI[OR=3.218,95%CI(1.3037.950),P=0.011];number of diseased vessels[OR=4.045,95%CI(1.199-14.627),P=0.033];independently associated with the occurrence of MACE.Conclusions:1.The prognosis of de novo coronary artery disease treated with DCB is adversely affected by diabetes mellitus and poor glycemic control.2.Intensive glycemic control significantly reduces the incidence of adverse events in patients with de novo coronary artery disease treated with DCB in combination with diabetes mellitus.3.The prognosis of patients with de novo coronary artery disease treated with DCB in combination with diabetes mellitus is improved by the use of aspirin+ticagrelor in addition to intensive glycemic control therapy.4.In patients with de-novo coronary artery disease with diabetes mellitus treated with DCB,glycemic control(HbA1C)may be an independent risk factor for MACE,and HbA1C may be a marker for increased risk of MACE. |
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