Assessing the Risks of Bleeding vs Thrombotic Events in Patients at High Bleeding Risk After Coronary Stent...

Area of Science:

• Cardiology
• Interventional Cardiology
• Clinical Risk Prediction

Background:

• Patients undergoing percutaneous coronary intervention (PCI) who are at high bleeding risk present a significant therapeutic challenge due to concurrent risks of thrombotic complications.
• Balancing the risks of bleeding and thrombosis is crucial for optimizing treatment strategies in this patient population.

Purpose of the Study:

• To develop and validate prognostic models for predicting major bleeding (Bleeding Academic Research Consortium [BARC] types 3-5) and myocardial infarction (MI) and/or stent thrombosis (ST) in patients at high bleeding risk undergoing PCI.
• To provide tools that assist in defining procedural strategies and antithrombotic regimens based on individual patient risk profiles.

Main Methods:

• Individual patient data from 6 studies (N=6641) of high bleeding risk patients undergoing PCI were analyzed.
• Forward, stepwise multivariable proportional hazards models were used to identify predictors of MI/ST and BARC types 3-5 bleeding.
• Models were validated using data from the ONYX ONE trial (N=1458).

Main Results:

• Two independent risk models were developed, identifying 8 predictors each for MI/ST and major bleeding, with 4 overlapping predictors.
• The models demonstrated moderate discrimination (C-statistics of 0.69 for MI/ST and 0.68 for bleeding), validated similarly in a separate cohort.
• Patients experiencing MI/ST had a 6.1-fold increased mortality risk, while those with major bleeding had a 3.7-fold increased risk compared to event-free patients.

Conclusions:

• Developed prognostic models can identify individual risks of major thrombotic and bleeding events in high bleeding risk patients undergoing PCI.
• These risk scores can help clinicians evaluate the trade-off between thrombotic and bleeding risks, guiding the selection of revascularization strategies and antithrombotic therapy.
• Future clinical application may involve smartphone-based tools to assess individual risk profiles and personalize treatment decisions.