Key result
Post-PCI overt bleeding with hemoglobin drop ≥3 g/dL linked to ~2.2-fold higher 2-year MACE risk.
Why the study?
The clinical relevance of defining major bleeding by a periprocedural hemoglobin drop of ≥3.0 g/dL, particularly in the absence of overt bleeding, remains uncertain.
Observational (n=7,145)
Yes
Hazard Ratio: 2.16 (95% CI 1.37–3.42)
Absolute Event Rate: 30.1% vs 12.1%
p-value: p=0.001
A periprocedural hemoglobin drop of ≥3.0 g/dL without overt bleeding is not associated with an increased 2-year risk of MACE after PCI, challenging conventional laboratory-only bleeding definitions.
Overt periprocedural bleeding with hemoglobin drop signals higher post-PCI MACE risk; challenges lab-only definitions but requires prospective confirmation.
BACKGROUND: Although most established bleeding definitions primarily emphasize overt bleeding, endpoints from major clinical trials and studies have historically defined major bleeding to include a periprocedural hemoglobin drop of ≥3.0 g/dL. However, the clinical relevance of this laboratory-based criterion, particularly without overt bleeding, remains uncertain. OBJECTIVES: The authors investigated the prognostic implication of a periprocedural hemoglobin drop of ≥3.0 g/dL, especially without overt bleeding. METHODS: Consecutive patients were analyzed from a Japanese registry between 2008 and 2021 after percutaneous coronary intervention (PCI). 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 2-year major adverse cardiac events (MACE, such as all-cause mortality, acute coronary syndrome, heart failure hospitalization, and 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%) had overt bleeding only; 590 (8.3%) had hemoglobin drop only; and 6,397 (89.5%) had no bleeding (reference). MACE occurred in 872 (12.2%; 95% CI: 11.5-13.0) patients during the median follow-up period of 730 (Q1-Q3: 730-730) days. 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 those patients with hemoglobin drop were not at increased risk of MACE (adjusted HR: 1.20; 95% CI: 0.89-1.60). CONCLUSIONS: Hemoglobin drop with overt bleeding after PCI was associated with increased 2-year MACE risk, whereas hemoglobin drop without overt bleeding had less prognostic relevance, highlighting the importance of clinical context in evaluating post-PCI bleeding.
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Suzuki et al. (2025) conducted an observational in Patients who underwent percutaneous coronary intervention (PCI) (n=7,145). Hemoglobin drop of ≥3.0 g/dL with overt bleeding vs. No bleeding was evaluated on 2-year major adverse cardiac events (MACE) (HR 2.16, 95% CI 1.37-3.42, p=0.001). A periprocedural hemoglobin drop of ≥3.0 g/dL with overt bleeding after percutaneous coronary intervention was associated with an increased 2-year risk of major adverse cardiac events compared to no bleeding (HR 2.16).
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