Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients
Study Details
Study Description
Brief Summary
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention (PCI) in high-risk patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Routine Angiography Follow-up (RAF) group Patients in the RAF group will have routine angiography follow-ups 12 months after revascularization. |
Diagnostic Test: Routine Angiography Follow-up
Patients in the RAF group will have routine angiography follow-ups 12 months after revascularization.
|
| Active Comparator: Routine Clinical Follow-up (RCF) group Patients in the RCF group will have routine clinical follow-ups 12 months after revascularization, and the physician will decide whether further invasive testing is needed. |
Diagnostic Test: Routine Clinical Follow-up
Patients in the RCF group will have routine clinical follow-ups 12 months after revascularization, and the physician will decide whether further invasive testing is needed.
|
Outcome Measures
Primary Outcome Measures
- Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina [24 months]
The primary endpoint was a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina
Secondary Outcome Measures
- Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina [60 months]
- All-cause death [24 and 60 months]
- Myocardial infarction [24 and 60 months]
- Hospitalization for unstable angina [24 and 60 months]
- Cardiac death. [24 and 60 months]
- Invasive angiography during follow-up [24 and 60 months]
- Any revascularization [24 and 60 months]
ischemia-driven vs. all-cause
- Revascularization of any target vessel/lesion [24 and 60 months]
- Revascularization of any non-target vessel/lesion [24 and 60 months]
- Health Economics Analysis (cost-effectiveness) [24 and 60 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years.
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Successful completion of PCI with at least one of the following high-risk factors:
- Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease; L. Myocardial infarction;
- Subject is able to verbally confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving invasive imaging evaluation and PCI. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
Exclusion Criteria:
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Revascularization with bare metal stents and/or balloon angioplasty with non-drug-coated balloons.
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Pregnant and/or lactating women.
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Life expectancy of less than 2 years.
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Repeat interventional therapy is planned.
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Subject was unable to provide written informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Jinhua Central Hospital
- Changxing People's Hospital
- The Affiliated Hospital of Hangzhou Normal University
- Second Affiliated Hospital of Shantou University Medical College
- Dongyang People's Hospital
- First Affiliated Hospital of Wenzhou Medical University
- Huizhou Municipal Central Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0332