Abstract
BackgroundPatients 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.MethodsWe 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.ResultsWe 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%).ConclusionThe 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.Supplementary InformationThe online version of this article (10.1007/s12471-021-01606-2) contains supplementary material, which is available to authorized users.
Highlights
Percutaneous coronary intervention (PCI) is the treatment of choice in most patients with acute coronary syndrome (ACS) and frequently performed in patients with chronic coronary artery syndrome [1]
Complex patients are treated with percutaneous coronary intervention (PCI), leading to a group of high-risk patients with multiple clinical risk factors being treated with dual or even triple antithrombotic therapy following PCI
International guidelines recommend a period of 6–12 months of dual antiplatelet therapy (DAPT) after PCI, sometimes in combination with oral anticoagulation if other comorbidities demand to do so [1, 2]
Summary
Percutaneous coronary intervention (PCI) is the treatment of choice in most patients with acute coronary syndrome (ACS) and frequently performed in patients with chronic coronary artery syndrome [1]. Evidence on optimal treatment exists for most patients, “high-risk” patients with multiple clinical risk factors (in whom both bleeding complications and recurrent ischaemic events occur more often) remain a challenging group. These patients are frequently excluded from or underrepresented in the large clinical trials, and several bleeding risk scores have been developed, these scores have not been validated in high-risk subjects [5]. 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. 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
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