Antiplatelet Agents, Perioperative Care
Conditions
Keywords
antiplatelet agents, perioperative care, coroanry artery disease, abdominal disease, noncardiac surgery
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.
Interventions
DRUGAspirin
perioperative aspirin continuation
DRUGAspirin interruption
Aspirin interruption 5-7 days before surgery
Sponsors
Kyoto University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a composite of death or myocardial infarction | 30 days | the primary endpoint is defined as a composite of all-cause death or myocardial infarction (4th UDMI definition) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death/Myocardial Infarction (4th UDMI Definition)/Stroke | 30 days | a composite of Death, Myocardial Infarction (4th UDMI Definition), or Stroke |
| Death/Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS) | 30 days | a composite of Death, Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS) |
| Myocardial Infarction (4th UDMI Definition)/Myocardial Injury (MINS) | 30 days | a composite of Myocardial Infarction (4th UDMI Definition), or Myocardial Injury (MINS) |
| Death/Myocardial Infarction (ARC-2 Definition)/Stroke | 30 days | a composite of Death, Myocardial Infarction (ARC-2 Definition), orStroke |
| Death | 30 days | all-cause death |
| Cardiovascular Death | 30 days | cardac and vascular death |
| Myocardial Infarction (4th UDMI Definition) | 30 days | Myocardial Infarction defined by 4th UDMI Definition |
| Myocardial Infarction (ARC-2 Definition) | 30 days | Myocardial Infarction defined by ARC-2 Definition |
| Myocardial Infarction (SCAI Definition) | 30 days | Myocardial Infarction defined by SCAI Definition |
| Myocardial Infarction (modified POISE-2 Definition) | 30 days | Myocardial Infarction defined by modified POISE-2 Definition |
| Myocardial Injury (MINS) | 30 days | Myocardial Injury (MINS) is defined as cardiac enzyme elevation without symptoms or ECG changes. |
| Major bleeding (TIMI major/minor bleeding) | 30 days | TIMI major/minor bleeding |
| Stroke | 30 days | Sudden neurological disorder that persists for at least 24 hours and is caused by blockage of cerebral blood flow due to bleeding or ischemia. |
| Cerebral Infarction | 30 days | Sudden neurological disorder that persists for at least 24 hours and is caused by infarction. |
| Cerebral Hemorrhage | 30 days | Sudden neurological disorder that persists for at least 24 hours and is caused by cerebral bleeding. |
| Coronary Revascularization | 30 days | PCI or CABG |
| Major Bleeding (BARC classification) | 30 days | Major bleeding defined by BARC classification |
| Major Bleeding (modified POISE-2 classification) | 30 days | Major bleeding defined by modified POISE-2 classification |
| Major Bleeding (GUSTO classification) | 30 days | Major bleeding defined by GUSTO classification |
| Fatal Bleeding | 30 days | Fatal bleeding within 30 days after abdominal surgery |
| Bleeding Volume During Non-Cardiac Surgery | 30 days | bleeding volume during abdominal surgery |
| Transfusion | 30 days | transfusion during and after surgery |
| Reoperation | 30 days | any reoperation |
| Stent Thrombosis (ARC Definition) | 30 days | Stent thrombosis defined by ARC definition |
Countries
Japan
Contacts
Primary ContactHiroki Shiomi, MD, PhD
Backup ContactErika Yamamoto, MD, PhD
Outcome results
None listed