Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)

Summary

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.

Conditions

• Non-valvular Atrial Fibrillation (NVAF)
• Thromboembolism
• Cardiac Implantable Electronic Device
• Perioperative Bleeding
• Hematoma Postoperative

Interventions

DRUG

Stepwise Anticoagulation Regimen

Experimental Regimen: For participants randomized to the stepwise anticoagulation group: 1. Discontinue edoxaban/rivaroxaban 1 day before CIED surgery (i.e., the last dose is administered on the day before surgery); 2. Resume reduced-dose edoxaban/rivaroxaban 24 hours after surgery: (1) For edoxaban: 15mg once daily for patients with standard 30mg dose, 30mg once daily for patients with standard 60mg dose; (2) For rivaroxaban: 10mg once daily for patients with standard 15mg dose, 15mg once daily for patients with standard 20mg dose. 3. Continue reduced-dose edoxaban/rivaroxaban until suture removal on postoperative day 7; 4. Resume standard-dose edoxaban (30mg/60mg once daily) or rivaroxaban (15mg/20mg once daily) after suture removal. Standard dose reduction criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy.

DRUG

Standard Anticoagulation Regimen

Active Comparator Regimen: For participants randomized to the standard anticoagulation group: 1. Discontinue edoxaban/rivaroxaban 1 day before CIED surgery(i.e., the last dose is administered on the day before surgery); 2. Resume full standard-dose edoxaban (30mg/60mg once daily) or rivaroxaban (15mg/20mg once daily) 24 hours after surgery; 3. Continue standard-dose edoxaban/rivaroxaban throughout the 30-day follow-up period. Standard dose criteria are defined per the study protocol based on renal function, body weight, age, concomitant medications, and antiplatelet therapy.

Sponsors & Collaborators

• Peking University First Hospital

  collaborator OTHER

• Fuwai Shenzhen Hospital

  collaborator UNKNOWN

• Beijing Boai Hospital, China Rehabilitation Research Center

  collaborator UNKNOWN

• Fu Wai Hospital, Beijing, China

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-26

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations