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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Anticipated): 950

Contacts and Locations

• Study Contact: Name: Xiaoli Liu, PhD, MD; Phone Number: 8613581633895; Email: liuxl9881@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Xiaoli Liu, PhD, MD; Phone Number: 8613581633895; Email: liuxl9881@163.com
      • Contact: Xiaoteng Ma, PhD, MD; Phone Number: 8618810616459; Email: maxiaotengai@163.com
      • Principal Investigator: Xiaoli Liu, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Coronary artery disease patients treated with oral antiplatelet therapy are planned to undergo non-cardiac surgery with high or extremely high surgical bleeding risk

Description

Inclusion Criteria:

1. Aged 18 years or over
2. Established coronary artery disease being treated with oral antiplatelet therapy
3. Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
4. Agree to participate in the study and provide written informed consent

Exclusion Criteria:

1. According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
2. Requiring emergency non-cardiac surgery within 24 hours after admission
3. Currently being bleeding
4. Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
5. Intracranial diseases or hemorrhagic diathesis
6. Contraindications for LMWH or GP IIb/IIIa receptor antagonists

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Bridging therapy with LMWH (n=475); Bridging therapy with LMWH was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery
Bridging therapy with tirofiban (n=475); Bridging therapy with tirofiban was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Xiaoli Liu, PhD, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery disease; Non-cardiac surgery; Bridging antithrombotic therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: SAFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No