Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 950
- Locations
- 1
- Primary Endpoint
- Major adverse cardiovascular events
- Last Updated
- 4 years ago
Overview
Brief Summary
Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.
Investigators
Yujie Zhou
PhD, MD
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or over
- •Established coronary artery disease being treated with oral antiplatelet therapy
- •Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
- •Agree to participate in the study and provide written informed consent
Exclusion Criteria
- •According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
- •Requiring emergency non-cardiac surgery within 24 hours after admission
- •Currently being bleeding
- •Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
- •Intracranial diseases or hemorrhagic diathesis
- •Contraindications for LMWH or GP IIb/IIIa receptor antagonists
Outcomes
Primary Outcomes
Major adverse cardiovascular events
Time Frame: Perioperative period
A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Secondary Outcomes
- TIMI major or minor bleeding(Perioperative period)
- Net adverse clinical events(30 days after surgery)