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

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.