Navigating Ischemic and Bleeding Risks in High Bleeding Risk Patients Undergoing Coronary Intervention

Abstract

Percutaneous coronary intervention (PCI) has become a cornerstone in the management of coronary artery disease. However, for patients at high bleeding risk (HBR), standard antithrombotic regimens may lead to major bleeding complications, thereby increasing mortality and morbidity. In recent years, numerous innovative strategies have been developed specifically for HBR patients, effectively resolving the core clinical dilemma of balancing ischemic protection and bleeding safety and significantly improving long-term clinical outcomes of this high-risk population. This review systematically summarizes the defining criteria for HBR, available risk assessment tools, and contemporary advances in PCI strategies including optimized vascular access, innovations in stent technology, and tailored antithrombotic therapies. We examine key clinical trials such as LEADERS FREE, ZEUS, SENIOR, MASTER DAPT, ONYX ONE, and TWILIGHT, with critical appraisal of their design limitations, population heterogeneity and endpoint differences, and comprehensively evaluate the efficacy and safety of shortened dual antiplatelet therapy (DAPT) duration, polymer-free drug-eluting stents, and de-escalation strategies for antithrombotic treatment. We systematically summarize the core design and clinical outcomes of pivotal antiplatelet therapy trials for HBR patients in a specialized table to intuitively clarify the evidence basis for individualized antiplatelet regimens. Furthermore, this article discusses individualized management approaches for special populations, including patients with atrial fibrillation, malignancy, or chronic kidney disease, along with recent updates in clinical guideline recommendations. Notably, we incorporate 2024–2026 cutting-edge evidence on ultra-short DAPT stratification strategies, gene-guided antiplatelet therapy adjustment, and novel factor XI (FXI) inhibitor antithrombotic regimens, further refining the individualized risk-balanced treatment system for HBR patients. Based on synthetic analysis of existing high-level evidence, this review constructs a standardized whole-process management framework for HBR patients undergoing PCI. Through precise risk stratification and personalized treatment plans, modern PCI strategies now allow for effective ischemic protection while minimizing bleeding risk, offering HBR patients a safer and more effective revascularization option.