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Bleeding and Thrombotic Trade-off in Dual-Risk Patients Undergoing Percutaneous Coronary Intervention
Maria Sara Mauro1, Simone Finocchiaro2, Dario Calderone3
1Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania, Italy.
Insights
Managing dual antiplatelet therapy (DAPT) in high-risk patients after percutaneous coronary intervention (PCI) is complex. A novel trade-off model helps personalize DAPT by stratifying patients based on predominant bleeding or thrombotic risk.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Pharmacology
Background:
- Dual antiplatelet therapy (DAPT) is crucial post-percutaneous coronary intervention (PCI).
- Current DAPT guidelines (6-12 months) face challenges in balancing thrombotic and bleeding risks, particularly in patients with high bleeding risk (HBR) and high thrombotic risk (HTR).
- Personalized DAPT strategies are needed for complex dual-risk patient populations.
Purpose of the Study:
- To characterize a contemporary dual-risk PCI population (HBR and HTR).
- To apply the Academic Research Consortium (ARC) trade-off model for risk stratification.
- To guide personalized DAPT management by determining predominant bleeding or thrombotic risk.
Main Methods:
- Screened 3,051 PCI patients (November 2019 - December 2023).
- Identified dual-risk patients using ARC-HBR and European Society of Cardiology (ESC) criteria.
- Stratified patients into three groups (DRBR
, DRBR=TR, DRBR>TR) using the ARC trade-off model based on bleeding vs. thrombosis risk. - Assessed net adverse clinical events (NACE) and individual components as primary and secondary outcomes.
Main Results:
- 12.4% of PCI patients were identified as dual-risk.
- The DRBR>TR group exhibited a significantly increased risk of NACE at 18 months (HR 1.77) compared to the DRBR=TR group.
- This increased NACE risk in the DRBR>TR group was driven by higher rates of major bleeding (HR 2.61) and myocardial infarction/stent thrombosis (MI/ST) (HR 3.36).
- Competing risk analysis confirmed these findings for both bleeding and thrombotic outcomes.
Conclusions:
- The ARC trade-off model effectively stratifies dual-risk PCI patients.
- Personalized DAPT strategies can be developed for this complex population.
- Reducing bleeding risk in dual-risk patients holds potential for improved clinical outcomes.
AbstractBackground:
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).
Objectives:
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.
Methods:
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: DRBR
, DRBR=TR, and DRBR>TR, 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. Results:
Among 3,051 PCI patients, 12.4% were identified as dual-risk. The trade-off model stratified these patients into DRBR
(56.1%), DRBR=TR (29.6%), and DRBR>TR (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). Conclusion:
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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