Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Interventio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0002920
- Lead Sponsor
- Asan Medical Center
- Brief Summary
we found no significant between-group difference in the primary composite outcome of death, myocardial infarction, or hospitalization for unstable angina at 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1707
Subject was > 19 years of age.
Subjects who underwent successful PCI with contemporary drug eluting stent or contemporary bioresorbable vascular scaffold.
Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.
3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).
3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (= 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length =30 mm or stent length =32 mm), or vein bypass graft stented
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Cardiogenic shock at the index admission
Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
Pregnant and/or lactating women.
Concurrent medical condition with a life expectancy of less than 1 years
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
6 Subject was unable to provide written informed consent or participate in long-term follow-up.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina
- Secondary Outcome Measures
Name Time Method Myocardial infarction;Unstable angina hospitalization;Death or Myocardial infarction;Any hospitalization;Invasive catheterization;Repeat revascularization procedure