Clinical Outcomes of Drug-Coated Balloon in Coronary Patients with and without Diabetes Mellitus: A Multicenter, Propensity Score Study

Abstract

Background. Relative to nondiabetic patients, percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) is associated with inferior clinical outcomes. We aimed to evaluate the outcomes of drug-coated balloon (DCB) in diabetic versus nondiabetic patients. Methods and Results. In this observational, prospective, multicenter study, we compared the outcomes of patients with and without DM after undergoing PCI with DCBs. Target lesion failure (TLF) was analyzed as primary endpoint. Secondary endpoints were the rates of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), and any revascularization. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics. Among 2,306 eligible patients, 578 with DM and 578 without DM had similar propensity scores and were included in the analyses. During follow-up ( 366 ± 46 days), compared with DM patients, patients without DM were associated with a lower yearly incidence of TLF (2.77% vs. 5.36%; OR, 1.991; 95% CI, 1.077 to 3.681; P = 0.025 ) and TLR (1.90% vs. 4.15%; OR, 2.233; 95% CI, 1.083 to 4.602; P = 0.026 ). No significant differences were observed with regards to rates of MACE (OR: 1.580, 95% CI: 0.912-2.735; P = 0.100 ), cardiac death (OR: 1.608, 95% CI: 0.523-4.946; P = 0.403 ), MI (OR: 4.042, 95% CI: 0.855-19.117; P = 0.057 ), and any revascularization (OR: 1.534, 95% CI: 0.983-2.393; P = 0.058 ). Conclusions. Diabetic patients experience higher TLF and TLR rates following DCB angioplasty without substantial increase in the risk of MACE, cardiac death, MI, or revascularization.

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“…Since the first performance of percutaneous coronary angioplasty in 1977 ( Grüntzig, 1978 ), the direct intervention of interventional therapy has been widely used in improving the living quality of patients. The vascular interventional technique (VIT) is an important branch of interventional therapy ( Cao et al, 2021 ; Pan et al, 2021 ), which is commonly used in the treatment of cardiovascular diseases (e.g., atherosclerosis). Although the clinical application is quite mature, adverse clinical events ( Daemen et al, 2007 ; Faxon, 2012 ; Qiu et al, 2021 ) including late thrombosis and intimal hyperplasia are still long-term side effects of the VIT.…”

Clinical outcomes of drug-coated balloon for treatment of de novo coronary artery disease with and without diabetes

“…Previous studies found that patients with DM have more diffuse and complex CAD than non-diabetic patients, which is also consistent with the current study that patients with diabetes had a smaller diameter of the coronary artery, longer lesions and more serious lesions. [17][18][19] These researches demonstrated that CAD in the presence of DM has unique characteristics. The high risk of MACE in patients with diabetes may be secondary to the complex pathophysiological mechanisms, including endothelial dysfunction, chronic inflammation, and activation of platelet.…”

“…16 One of the beneficial feature of DCB is the local delivery of paclitaxel to coronary artery without leaving metal sten. 17 As a result, DCB decreased the incidence and de novo lesion, especially in small vessel disease. 17,18 However adverse events risk in patients with diabetes treated with DCB had not been fully assessed.…”

“…17 As a result, DCB decreased the incidence and de novo lesion, especially in small vessel disease. 17,18 However adverse events risk in patients with diabetes treated with DCB had not been fully assessed. Until now, only one research has discussed outcomes of DCB in diabetic patients.…”

“…Until now, only one research has discussed outcomes of DCB in diabetic patients. Pan et al 17 reported that diabetic patients had higher TLF and TLR rates following DCB angioplasty without a substantial increase in the risk of MACE, cardiac death, myocardial infarction, and revascularization.…”