Drug‐Coated Balloon‐Based Strategy for De Novo Coronary Artery Disease Across Complex and High‐Risk Indicated Percutaneous Coronary Intervention Risk Categories: A Multicenter Registry Study

BACKGROUND: Evidence regarding the risk-stratified effectiveness of drug-coated balloon (DCB)-based PCI for de novo coronary artery disease (CAD) remains limited, particularly in patients undergoing complex and high-risk indicated percutaneous coronary intervention (CHIP PCI). AIMS: To compare the efficacy and safety of DCB-based PCI versus DES-only PCI for de novo CAD across CHIP risk categories. METHODS: Patients treated with DCB alone or with a hybrid DCB/drug-eluting stent (DES) strategy between 2010 and 2023 were retrospectively analyzed (DCB-based group). The comparator group included patients treated exclusively with second-generation DES from a Korean multicenter registry. The primary endpoint was the 2-year incidence of major adverse cardiovascular events (MACE): cardiac death, myocardial infarction, target vessel revascularization (TVR), target lesion thrombosis, and major bleeding. RESULTS: Total 2022 propensity score-matched pairs were stratified by CHIP score into low (0-2; 1660 pairs), intermediate (3-4; 304 pairs), and high (≥ 5; 91 pairs) risk groups. DCB-only treatment accounted for 70.8% of the DCB-based group, with hybrid approaches more frequent in higher-risk patients. Two-year MACE rates increased with CHIP risk in both groups, but remained consistently lower in the DCB-based group: 5.3%, 6.3%, and 20.0% versus 10.9%, 16.9%, and 31.2% for DES-only PCI (log-rank p < 0.001). DCB-based PCI was associated with lower MACE risk across all CHIP categories (all p < 0.05), with no significant interaction (p-interaction = 0.819). TVR reduction was significant in the low-to-intermediate risk (p-interaction = 0.056), and major bleeding declined with increasing CHIP risk, most notably in the high-risk group (p-interaction = 0.044). CONCLUSIONS: DCB-based PCI was associated with significantly lower 2-year MACE rates across all CHIP risk categories and may offer a potential alternative to DES-only strategies in selective patients. Clinical trial registration number REAL-DCB registry (NCT04619277), PTRG-DES registry (NCT04734028).