Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.
The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.
In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.
In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").
Age ≥18 years
Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months
Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.
Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.
Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)
Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion
AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure
Prior mechanical valvular prosthesis implantation
Parallel
P2Y12 inhibitor
DrugThe choice of P2Y12 inhibitor is left at investigator's discretion.
Aspirin
DrugAspirin is administered for up to 1 month after PCI at investigator's discretion
DOAC
DrugThe choice of DOAC is left at investigator's discretion.
The number of participants with a major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke or non-central nervous system (non-CNS) systemic embolism
The number of participants with a major or clinically relevant non-major bleeding (MCB), defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria
The incidence of MACCE or MCB
MACCE, defined as the composite of death from any cause, myocardial infarction, stroke or non-CNS systemic embolism and MCB, defined according to the ISTH criteria
The incidence of MACCE or MCB
MACCE, defined as the composite of death from any cause, myocardial infarction, stroke or non-CNS systemic embolism and MCB, defined according to the ISTH criteria
The number of participants with a composite of death from cardiovascular causes, myocardial infarction or stroke
The number of participants with a composite of death from cardiovascular causes, myocardial infarction or stroke
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
Sahajanand Medical Technologies Limited
Collaborator
