Outcomes of Drug-Coated Balloon Versus Drug-Eluting Stent for In-Stent Restenosis and De-Novo Lesions: A Meta-Analysis of Randomized Controlled Trials

药物涂层球囊与药物洗脱支架治疗支架内再狭窄和新发病变的疗效比较:随机对照试验的荟萃分析

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Abstract

BACKGROUND AND AIMS: Drug-coated balloons (DCBs) and drug-eluting stents (DESs) are commonly used in percutaneous coronary interventions (PCI), but their long-term comparative effectiveness remains unclear. This meta-analysis aimed to compare the clinical and angiographic outcomes of DCB versus DES in patients with in-stent restenosis (ISR) and de novo lesions, including ST-elevation myocardial infarction (STEMI) and small vessel disease (SVD). METHODS: A systematic search identified randomized controlled trials (RCTs) comparing DCBs and DESs. The primary outcome was target lesion revascularization (TLR), with secondary outcomes including all-cause mortality, cardiovascular mortality, myocardial infarction, stent/lesion thrombosis, and late lumen loss (LLL). The frequentist network meta-analysis and binary random-effect analysis were used to compare DCB versus. DES. RESULTS: A total of 21 RCTs with 4244 patients were included. In ISR patients, the risk of TLR was comparable between DCB vs. DES at 1-year (OR: 1.36, 95% CI: 0.86-2.14) and beyond 1-year (OR: 1.23, 95% CI: 0.79-1.93). DCB and DES showed no significant difference in other secondary outcomes at 1-year and beyond. In STEMI and SVD patients, DCB and DES demonstrated similar outcomes, except for a lower LLL after DCB in patients with SVD (SMD: -0.38, 95% CI: -0.53 to -0.22). CONCLUSION: DCB and DES were associated with a similar risk of TLR in patients with ISR, STEMI, and SVD. The results were consistent at 1-year and beyond time intervals. Furthermore, DCB was associated with a lower LLL compared to DES in patients with SVD.

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