SAfety and EFficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bridging therapy with LMWH (n=475)<br>Bridging therapy with LMWH was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery | |
| Bridging therapy with tirofiban (n=475)<br>Bridging therapy with tirofiban was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke | Perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI major or minor bleeding | A composite of major or minor bleeding events as defined by the TIMI bleeding criteria | Perioperative period | 
| Net adverse clinical events | A composite of major adverse cardiovascular events and TIMI major or minor bleeding | Perioperative period | 
| Net adverse clinical events | A composite of major adverse cardiovascular events and TIMI major or minor bleeding | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bridging antithrombotic therapy, Non-cardiac surgery, coronary artery disease