Background: While most established bleeding definitions primarily emphasize overt bleeding, endpoints from major clinical trials and studies have historically defined major bleeding to include a peri-procedural hemoglobin drop of ≥3.0 g/dL. However, the clinical relevance of this laboratory-based criterion, particularly without overt bleeding, remains uncertain.
Objectives: We investigated the prognostic implication of a peri-procedural hemoglobin drop of ≥3.0 g/dL, especially without overt bleeding.
Methods: Consecutive patients after percutaneous coronary intervention (PCI) between 2008 to 2021 from a Japanese registry were analyzed. Patients were classified by hemoglobin drop (≥3.0 g/dL decrease between pre- and post-PCI) and overt bleeding. Cox regression assessed associations between these groups and two-year major adverse cardiovascular events (MACE: all-cause mortality, acute coronary syndrome, heart failure hospitalization, stroke).
Results: Among 7,145 patients (mean age 69 years, 77.0% male), 73 (1.0%) had both overt bleeding and hemoglobin drop; 85 (1.2%) overt bleeding only; 590 (8.3%) hemoglobin drop only; 6,397 (89.5%) no bleeding (reference). MACE occurred in 872 (12.2% [95% CI: 11.5-13.0]) patients during the median follow-up period of 730 days (IQR 730-730). MACE incidence was 30.1% [95% CI: 19.9-42.0] in patients with overt bleeding and hemoglobin drop, with higher risk than those without bleeding (adjusted HR: 2.16; 95% CI: 1.37-3.42). Only hemoglobin drop were not at increased risk of MACE (adjusted HR: 1.20; 0.89-1.60).
Conclusions: Hemoglobin drop with overt bleeding after PCI was associated with increased two-year MACE risk, while hemoglobin drop without overt bleeding had less prognostic relevance, highlighting the importance of clinical context in evaluating post-PCI bleeding.
Editors
JACC: Asia Editor-in-Chief
Jian’an Wang, MD, PhD, FACC
CME Editor
Kenneth A. Ellenbogen, MD
Author
Sabeeda Kadavath, MD FACC
Important Dates
Date of Release: December 2, 2025
Term of Approval/Date of CME/MOC Expiration: December 1, 2026