TCTAP A-002
DES/BRS/DCB
Drug-Coated Balloon-Based Treatment for De Novo Coronary Artery Disease in Patients With High-Bleeding Risk
Eun-Seok Shin1, Sunwon Kim2, Mi Hee Jang1, Chang-Bae Sohn3, Dong Oh Kang4, Bitna Kim1, Ae-Young Her5
Ulsan University Hospital, Korea (Republic of)1, Korea University Ansan Hospital, Korea (Republic of)2, Ulsan Medical Center, Korea (Republic of)3, Korea University Guro Hospital, Korea (Republic of)4, Kangwon National University Hospital, Korea (Republic of)5
Background
Despite the well-documented benefits of more potent and prolonged antiplatelet therapy in drug-eluting stent (DES)-based percutaneous coronary intervention (PCI), bleeding events remain a critical predictor of morbidity and mortality following PCI. Drug-coated balloons (DCBs) have demonstrated potential as an alternative to DESs in certain cases of de novo lesions or patients with high-bleeding risk (HBR). Managing patients with HBR requiring PCI is challenging, and data are limited. This study investigates the clinical outcomes of DCB-based PCI compared to DES-only PCI in patients with HBR undergoing PCI.
Methods
We included 828 consecutive patients with HBR undergoing DCB-based PCI compared them to 828 propensity-matched patients who received conventional PCI with second-generation DES. Patients were followed up for 2 years to assess major adverse cardiovascular events (MACE: a composite of cardiac death, myocardial infarction, stroke, definite stent thrombosis, target vessel revascularization, and major bleeding). The presence of HBR was defined by fulfilling at least one major criterion or two minor criteria based on the ARC for HBR: age ≥75 (minor), oral anticoagulation (major), chronic kidney disease (estimated glomerular filtration rate <60 mL/min [minor], estimated glomerular filtration rate <30 mL/min [major]), hemoglobin (<11 g/dL [major], male and 11–12.9 g/dL [minor], female and 11–11.9 g/dL [minor]), thrombocyte count <100 K/µL (major), reported liver disease (major), reported non-skin cancer (major), previous stroke or transient ischemic attack (minor), or oral nonsteroidal anti-inflammatory drug (minor). If no information was available regarding a certain criterion, it was considered negative and thus not suggestive of HBR. All DCB were coated with 3.0 μg/mm2 paclitaxel combined with iopromide, as a carrier for the drug.
Results
Baseline clinical characteristics werecomparable between the groups. In the DCB-based group, 69.0% of patients weresuccessfully treated with DCB alone. In the DCB-based PCI, patients had lowercardiac mortality at 2 years (1.6% vs. 3.6%; hazard ratio: 0.38; 95% confidenceinterval: 0.18–0.80; P = 0.011). Rates of target vessel revascularization (2.8%vs. 6.6%; hazard ratio: 0.39; 95% confidence interval: 0.23–0.68; P = 0.001),and major bleeding events (1.3% versus 7.7%; hazard ratio: 0.14; 95% confidenceinterval: 0.07–0.29; P <0.001) were also lower with DCB-based PCI than thosewith DES-only PCI. Myocardial infarction and stroke events were comparablebetween the two groups. In a multivariable model, DCB-based PCI wasindependently associated with reduced risk of 2-year cardiac death, targetvessel revascularization, and major bleeding.
Conclusion
In patients with HBR, DCB-based PCI was associatedwith a significantly lower risk of MACE compared to DES-only treatment. Thesefindings suggest that DCB-based PCI is a viable treatment strategy forimproving outcomes in patients with HBR. Additional prospective, randomizedstudies are necessary to determine the safety and efficacy of the DCB-basedtreatment approach for improving clinical outcomes in patients with HBR.
