What is the clinical evidence from this study?

Study design: Observational. Population: Patients undergoing percutaneous coronary intervention (PCI) (n=6267). Intervention: High bleeding risk (ARC-HBR) status vs. Non-high bleeding risk (non-ARC-HBR) status. Primary outcome: Incidence of major bleeding at 12 months post index PCI (HR 3.00, 95% CI 2.11-4.27, p=<0.001).

February 1, 2021Open Access

High bleeding risk and clinical outcomes in East Asian patients undergoing percutaneous coronary intervention: the PENDULUM registry

Q: What are the key findings of this study?

Meeting the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria was associated with a significantly higher incidence of major bleeding at 12 months post-PCI (4.2% vs 1.4%, HR 3.00).

Key Result

Meeting the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria was associated with a significantly higher incidence of major bleeding at 12 months post-PCI (4.2% vs 1.4%, HR 3.00).

Study Design

Type

Observational (n=6,267)

Multicenter

Yes

Structured PICO

Does the ARC-HBR criteria accurately predict major bleeding in East Asian patients undergoing PCI?

Population

6,267 Japanese patients aged ≥20 years undergoing percutaneous coronary intervention with a second-generation drug-eluting stent, followed for 12 months.

Exposure

Stratification into the Academic Research Consortium for High Bleeding Risk (ARC-HBR) group (n=3,185).

Comparator

Non-ARC-HBR group (n=3,082).

Outcome

Incidence of major bleeding at 12 months post index PCI.safety

The ARC-HBR criteria are valid and applicable for predicting 12-month major bleeding risk in Japanese patients undergoing contemporary PCI.

Main Result

Hazard Ratio: 3 (95% CI 2.11–4.27)

Absolute Event Rate: 4.2% vs 1.4%

p-value: p=<0.001

Limitations

Post hoc nature of the analysis meant not all variables from the original ARC-HBR definitions were collected
Selection bias was inevitable due to the observational study design
The 4% cut-off for major bleeding incidence may not be suitable for Japanese patients
Results may not be completely generalizable to other East Asian populations
Did not use a quantitative description for heart failure
Did not assess the risk of cardiovascular events or mortality

Abstract

AIMS: We aimed to evaluate the validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria for East Asian patients undergoing contemporary percutaneous coronary intervention (PCI) from the PENDULUM registry. METHODS AND RESULTS: This post hoc analysis included 6,267 Japanese patients undergoing PCI between December 2015 and June 2017 enrolled in PENDULUM. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. In total, 3,185 (50.8%) and 3,082 (49.2%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively, and almost all patients had overlapping criteria. Incidence of major bleeding was 4.2% versus 1.4% in the ARC-HBR group versus the non-ARC-HBR group (hazard ratio 3.00 95% confidence interval: 2.11-4.27; p<0.001). As the number of overlapping ARC-HBR criteria increased, the incidence of major bleeding also increased. In contrast, the incidence of major bleeding was 4.2% for one major criterion, 2.1% for two minor criteria. Multivariate analysis suggested that severe CKD, anticoagulant use, acute coronary syndrome, low body weight and heart failure were independent predictors of major bleeding. CONCLUSIONS: Half of the Japanese patients who underwent PCI in the PENDULUM registry met the ARC-HBR criteria, and many patients had overlapping criteria. ARC-HBR criteria are applicable to Japanese patients undergoing contemporary PCI.

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