Rivaroxaban Monotherapy and CYP2C19 Genotype Testing in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention

Prior treatment

• Systemic treatment with strong inhibitors or inducers of both cytochrome P450 (CYP) 3A4 and p-glycoproteine (P-gp; e.g. ketoconazole or carbamazepine)
• Participation in another trial with an investigational drug or device (i.e. stent

Other illness

• Known allergy or contraindication for rivaroxaban
• Mechanical heart valve prosthesis
• Active malignancy excluding non-melanoma skin cancer
• Active bleeding on randomization
• Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS
• PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions
• Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)

Lab values

• Kidney failure (eGFR <15)
• Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)

Other

• Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
• Intracardiac thrombus or apical aneurysm requiring OAC
• Suboptimal stenting result based on angiographic and optional intra-coronary imaging input
• Severe anaemia requiring blood transfusion
• Pregnancy or breast-feeding women
• Overwriting indication for DAPT (e.g. TIA/CVA or PAD)

• Age ≥18 years
• Successful PCI
• History of or newly diagnosed (<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC
• Treatment with a loading dose of clopidogrel prior to or during PCI