This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.
Aged 18 years or older at the time of screening, and able to provide written informed consent;
Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;
Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;
Diagnosed with non-valvular atrial fibrillation (and/or atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.
Presence of active systemic or local infection at the time of screening;
Estimated glomerular filtration rate (eGFR) <30 mL/min, or any other contraindication to NOAC use;
Active bleeding (e.g., gastrointestinal bleeding);
Severe thrombocytopenia, defined as platelet count < 50 × 10⁹/L at screening;
Fu Wai Hospital, Beijing, China
Lead sponsor
Peking University First Hospital
Collaborator
Fuwai Shenzhen Hospital
Collaborator
Beijing Boai Hospital, China Rehabilitation Research Center
Collaborator