What is the clinical evidence from this study?

Study design: Other. Population: Dual-Risk Patients Undergoing Percutaneous Coronary Intervention.

What does this research mean for the field?

The ARC trade-off model successfully stratifies dual-risk PCI patients, demonstrating that those with a predominantly higher bleeding risk experience significantly increased rates of net adverse clinical events, including both bleeding and thrombotic outcomes. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

May 29, 2026

Bleeding and Thrombotic Trade-off in Dual-Risk Patients Undergoing Percutaneous Coronary Intervention

Key Result

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Structured PICO

Does the ARC trade-off model predict net adverse clinical events in dual-risk patients undergoing percutaneous coronary intervention?

Population

3,051 patients who underwent percutaneous coronary intervention (PCI) between November 2019 and December 2023, including a 12.4% subset identified as dual-risk (high bleeding risk by ARC-HBR criteria and high thrombotic risk by ESC criteria).

Intervention

Stratification by the Academic Research Consortium (ARC) trade-off model into DRBR>TR (risk of death from bleeding higher than thrombosis) or DRBR<TR (risk of death from bleeding lower than thrombosis) groups.

Comparator

DRBR=TR group (risk of death from bleeding similar to thrombosis).

Outcome

Net adverse clinical events (NACE), defined as a composite of all-cause death, myocardial infarction (MI), stent thrombosis (ST), or major bleeding at 18 months.composite

The ARC trade-off model successfully stratifies dual-risk PCI patients, identifying those at highest risk for adverse events who may benefit from personalized dual antiplatelet therapy strategies.

Abstract

Abstract Dual antiplatelet therapy (DAPT) is essential after percutaneous coronary intervention (PCI). Current guidelines recommend 6 to 12 months of DAPT, but managing thrombotic and bleeding risks is challenging, especially in patients with both high bleeding risk (HBR) and high thrombotic risk (HTR). This study aimed to characterize a contemporary dual-risk PCI population (HBR and HTR) and used the Academic Research Consortium (ARC) trade-off model to determine the predominant risk (bleeding or thrombosis) to support personalized DAPT management. All patients who underwent PCI between November 2019 and December 2023 were screened. Dual-risk patients were identified using ARC-HBR criteria for bleeding and European Society of Cardiology (ESC) thrombotic criteria. The ARC trade-off model further stratified these patients into three groups: DRBRTR, based on whether the risk of death from bleeding was lower, similar, or higher than the risk of death from thrombosis. The primary outcome was net adverse clinical events (NACE), defined as a composite of all-cause death, myocardial infarction (MI), stent thrombosis (ST), or major bleeding. Secondary outcomes included individual components of NACE. Among 3,051 PCI patients, 12.4% were identified as dual-risk. The trade-off model stratified these patients into DRBRTR (14.3%) groups. At 18 months, the DRBR>TR group showed a significantly increased risk of NACE (HR 1.77, 95% CI, 1.04 to 3.03, p = 0.03) versus the DRBR=TR group, driven by higher rates of both major bleeding (HR 2.61, 95% CI, 1.08 to 6.67, p = 0.03) and MI/ST (HR 3.36, 95% CI, 1.21 to 9.30, p = 0.02). These findings were confirmed in competing risk analysis using Fine–Gray regression, both for bleeding (HR 3.0, 95% CI, 1.24 to 7.25; p = 0.015) and for thrombotic outcomes (HR 3.13, 95% CI, 1.14 to 8.64; p = 0.027). A contemporary trade-off model successfully stratified the dual-risk population, enabling personalized DAPT strategies for this complex population. Reducing bleeding risk in dual-risk patients may improve clinical outcomes.

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