December 13, 2023Open Access

Impact of the Japanese Version of High Bleeding Risk Criteria on Clinical Outcomes in Patients with ST-segment Elevation Myocardial Infarction

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: ST-segment elevation myocardial infarction (STEMI) (n=897). Intervention: Japanese version of the high bleeding risk criteria (J-HBR) vs. Non-J-HBR. Primary outcome: Major adverse cardiovascular events (MACE) (HR 4.676, 95% CI 2.936-7.448, p=<0.001).

SKSatoshi KonomaThe University of Tokyo KSKenichi SakakuraJichi Medical University HJHiroyuki JinnouchiInterventional Cardiology

Key Result

The Japanese version of the high bleeding risk criteria (J-HBR) was significantly associated with an increased risk of major adverse cardiovascular events (HR 4.676) and total bleeding events (HR 6.325) in patients with STEMI.

Study Design

Type

Cohort (n=897)

Multicenter

Structured PICO

Does meeting the Japanese version of the high bleeding risk criteria (J-HBR) predict MACE and bleeding events in patients with STEMI?

Population

897 patients with ST-segment elevation myocardial infarction (STEMI)

Intervention

Meeting Japanese version of the high bleeding risk criteria (J-HBR) (n=567)

Comparator

Not meeting J-HBR criteria (non-J-HBR group) (n=330)

Outcome

Major adverse cardiovascular events (MACE), defined as the composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and systemic embolism; and total bleeding events defined as type 3 or 5 bleeding events as defined by the Bleeding Academic Research Consortiumcomposite

The Japanese version of the high bleeding risk criteria (J-HBR) is a significant predictor of both major adverse cardiovascular events and major bleeding in patients with STEMI.

Main Result

Effect estimate: HR 4.676 (95% CI 2.936-7.448)

Absolute Event Rate: 29.3% vs 6.4%

p-value: p=<0.001

Limitations

Single-center, retrospective study design with potential selection bias
Lack of information regarding post-discharge medications
J-HBR concept was published in the middle of the inclusion period, so some patients were not recognized as high risk in clinical practice
Arbitrary selection of variables for the multivariate Cox hazard analysis

Abstract

AIMS: Bleeding complications are often observed in patients with ST-segment elevation myocardial infarction (STEMI). Although the Japanese version of the high bleeding risk criteria (J-HBR) were established, it has not been sufficiently validated in patients with STEMI. This retrospective study aims to examine whether J-HBR is associated with cardiovascular and bleeding events in patients with STEMI. METHODS: We included 897 patients with STEMI and divided them into the J-HBR group (n=567) and the non-J-HBR group (n=330). The primary endpoint was the major adverse cardiovascular events (MACE), defined as the composite of all-cause death, non-fatal myocardial infarction, ischemic stroke, and systemic embolism. Another primary endpoint was total bleeding events defined as type 3 or 5 bleeding events as defined by the Bleeding Academic Research Consortium . RESULTS: During the median follow-up duration of 573 days, 187 MACE and 141 total bleeding events were observed. The Kaplan-Meier curves showed that MACE and total bleeding events were more frequently observed in the J-HBR group than in the non-J-HBR group (p＜0.001). Multivariate Cox hazard analysis revealed that after controlling for multiple confounding factors, the J-HBR group was significantly associated with MACE (hazard ratio HR 4.676, 95% confidence interval (CI) 2.936-7.448, p＜0.001) and total bleeding events (HR 6.325, 95% CI 3.376-11.851, p＜0.001). CONCLUSIONS: J-HBR is significantly associated with MACE and total bleeding events in patients with STEMI. This study validated J-HBR as a risk marker for bleeding events and suggests J-HBR as a potential risk marker for MACE in patients with STEMI.

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