Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.

Detailed Description
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Subjects who can not be randomized due to any reason will be enrolled at observational group.

Official Title
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Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

Conditions
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Antiplatelet Drugs

Intervention / Treatment
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* Drug: Aspirin only
* Drug: No antiplatelet therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent Low or intermediate risk level surgery Written informed consent Exclusion Criteria: Acute coronary syndrome within 1 month Heart failure NYHA III to IV Contraindication to Aspirin On anticoagulant therapy Emergent surgery Cardiac surgery High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery Pregnancy or breast-feeding Life expectancy less than 1year

Ages Eligible for Study
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Minimum Age: 19 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin only<br> | Drug: Aspirin only<br>* Aspirin only during surgery<br>|
| Active Comparator: No antiplatelet therapy<br> | Drug: No antiplatelet therapy<br>* No antiplatelet therapy will be during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The event rate of all cause death |  | 30 days | 
| The event rate of cardiac death |  | 30 days | 
| The event rate of myocardial infarction |  | 30 days | 
| The event rate of stroke |  | 30 days | 
| The event rate of stent thrombosis |  | 30 days | 
| The event rate of repeat revascularization |  | 30 days | 
| The event rate of life threatening bleeding |  | 30 days | 
| The event rate of major bleeding |  | 30 days | 
| Quality of life score assessed by the EQ-5D-5L | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively. | 30 days | 
| Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8) | HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness. Higher score of HINT-8 means the high quality of life. The minimum and maximum values are 0 and 100 respectively if convert to a percentage. | 30 days | 
| Cost-effective analysis | Cost-effective analysis based on average treatment costs for two perioperative antiplatelet therapy_Aspirin only vs. No antiplatelet therapy_in patients with drug-eluting stent undergoing non-cardiac surgery. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting stent, antiplatelet therapy, noncardiac surgery