Optimal PERioperative Antiplatelet Therapy Investigation ON Abdominal Surgery After Coronary Stent Implantation
Overview
- Phase
- Phase 4
- Intervention
- Aspirin
- Conditions
- Antiplatelet Agents
- Sponsor
- Kyoto University
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- a composite of death or myocardial infarction
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the impact of perioperative aspirin continuation on clinical outcomes in patients with a history of coronary stent implantation who are scheduled for abdominal surgery.
Detailed Description
PCI with coronary stent implantation is performed for a huge number of patients with coronary artery disease. Approximately 20% of these patients undergo non-cardiac surgery within three years after PCI. However, there is a scarcity of clinical evidence regarding the efficacy of perioperative aspirin continuation on cardiovascular events.
Investigators
Hiroki Shiomi
Hiroki Shiomi MD, PhD
Kyoto University
Eligibility Criteria
Inclusion Criteria
- •Patients with a history of coronary stenting and scheduled for abdominal surgery
- •Patients on a single antiplatelet agent
Exclusion Criteria
- •Patients on dual antiplatelet therapy (DAPT)
- •Patients on anticoagulation therapy
- •Patients with a history of stent thrombosis
- •Patients with CHADS2 score \>= 5
- •Patients at extremely high risk of bleeding and unable to continue preoperative aspirin
- •Patients incapable of consent, including those under 20 years of age
- •Other patients for whom either discontinuation or continuation of antiplatelet agents is deemed inappropriate by the attending physician
Arms & Interventions
Aspirin Continuation
perioperative aspirin continuation
Intervention: Aspirin
Interruption of Antiplatelet Therapy
Interruption of aspirin 5-7 days before surgery
Intervention: Aspirin interruption
Outcomes
Primary Outcomes
a composite of death or myocardial infarction
Time Frame: 30 days
the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition)
Secondary Outcomes
- Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)(30 days)
- Major bleeding (TIMI major/minor bleeding)(30 days)
- Death/Myocardial Infarction (4th UDMI Definition)/Stroke(30 days)
- Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS)(30 days)
- Death/Myocardial Infarction (ARC-2 Definition)/Stroke(30 days)
- Death(30 days)
- Cardiovascular Death(30 days)
- Myocardial Infarction (4th UDMI Definition)(30 days)
- Myocardial Infarction (ARC-2 Definition)(30 days)
- Myocardial Infarction (SCAI Definition)(30 days)
- Myocardial Infarction (modified POISE-2 Definition)(30 days)
- Myocardial Injury (MINS)(30 days)
- Stent Thrombosis (ARC Definition)(30 days)
- Stroke(30 days)
- Cerebral Infarction(30 days)
- Cerebral Hemorrhage(30 days)
- Coronary Revascularization(30 days)
- Major Bleeding (BARC classification)(30 days)
- Major Bleeding (modified POISE-2 classification)(30 days)
- Major Bleeding (GUSTO classification)(30 days)
- Fatal Bleeding(30 days)
- Bleeding Volume During Non-Cardiac Surgery(30 days)
- Transfusion(30 days)
- Reoperation(30 days)