Antithrombotic therapy in high-risk patients after percutaneous coronary intervention; study design, cohort profile and incidence of adverse events
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R H Olie1,2, P E J van der Meijden3,4, M J A Vries4
1Thrombosis Expertise Centre, Heart and Vascular Centre, Department of Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands. Renske.olie@mumc.nl.
Insights
High-risk patients on dual/triple antithrombotic therapy after percutaneous coronary intervention face significant bleeding and ischemic event risks. This study characterized these risks and outcomes in a large cohort to guide future treatment strategies.
Area of Science:
- Cardiology
- Thrombosis Research
- Clinical Trials
Background:
- Patients with multiple risk factors undergoing percutaneous coronary intervention (PCI) face complex treatment decisions due to high risks of bleeding and recurrent ischemic events.
- Optimal antithrombotic strategies for these high-risk patients remain unclear, lacking definitive guideline recommendations.
Purpose of the Study:
- To present the design of a prospective observational cohort study evaluating patient factors, platelet reactivity, genetics, and biomarkers in predicting adverse events.
- To describe the cohort and analyze bleeding and ischemic outcomes during follow-up.
- To facilitate future research on managing high-risk patients on dual/triple antithrombotic therapy.
Main Methods:
- Inclusion of patients with ≥3 predefined risk factors treated with dual/triple antithrombotic therapy post-PCI.
- Performance of comprehensive hemostatic tests.
- Collection of all ischemic and bleeding events over 6-12 months follow-up.
Main Results:
- 524 high-risk patients were included, with 48.5% experiencing bleeding events (17.5% requiring intervention/admission).
- Major adverse cardiovascular events occurred in 13.2% of patients.
- Patients were treated with P2Y12 inhibitors, aspirin, and/or anticoagulants.
Conclusions:
- The high incidence of both bleeding and ischemic events highlights the challenges in optimizing antithrombotic therapy for high-risk patients.
- This cohort provides a valuable resource for future research into optimal management strategies and the utility of laboratory tests in guiding treatment decisions.
Background:
Patients with multiple clinical risk factors are a complex group in whom both bleeding and recurrent ischaemic events often occur during treatment with dual/triple antithrombotic therapy after percutaneous coronary intervention. Decisions on optimal antithrombotic treatment in these patients are challenging and not supported by clear guideline recommendations. A prospective observational cohort study was set up to evaluate patient-related factors, platelet reactivity, genetics, and a broad spectrum of biomarkers in predicting adverse events in these high-risk patients. Aim of the current paper is to present the study design, with a detailed description of the cohort as a whole, and evaluation of bleeding and ischaemic outcomes during follow-up, thereby facilitating future research questions focusing on specific data provided by the cohort.
Methods:
We included patients with ≥ 3 predefined risk factors who were treated with dual/triple antithrombotic therapy following PCI. We performed a wide range of haemostatic tests and collected all ischaemic and bleeding events during 6-12 months follow-up.
Results:
We included 524 high-risk patients who underwent PCI within the previous 1-2 months. All patients used a P2Y12 inhibitor (clopidogrel n = 388, prasugrel n = 61, ticagrelor n = 75) in combination with aspirin (n = 397) and/or anticoagulants (n = 160). Bleeding events were reported by 254 patients (48.5%), necessitating intervention or hospital admission in 92 patients (17.5%). Major adverse cardiovascular events (myocardial infarction, stroke, death) occurred in 69 patients (13.2%).
Conclusion:
The high risk for both bleeding and ischaemic events in this cohort of patients with multiple clinical risk factors illustrates the challenges that the cardiologist faces to make a balanced decision on the optimal treatment strategy. This cohort will serve to answer several future research questions about the optimal management of these patients on dual/triple antithrombotic therapy, and the possible value of a wide range of laboratory tests to guide these decisions.
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