Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention
POST PCI
a Multi-center, Open-label, Nationwide Registry-based, Randomized, Pragmatic Trial Comparing 2 Post-PCI Management Strategies in High-risk PCI Patients With Complex Clinical and Lesion Characteristics
1 other identifier
interventional
1,700
1 country
11
Brief Summary
The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedApril 5, 2022
April 1, 2022
4 years
July 13, 2017
April 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of major cardiovascular events
a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.
2 year
Secondary Outcomes (7)
Death
2 year
Myocardial infarction
2 year
Unstable angina hospitalization
2 year
Death or myocardial infarction
2 year
Any hospitalization
2 year
- +2 more secondary outcomes
Study Arms (2)
No Routine stress testing after PCI
ACTIVE COMPARATORRoutine stress testing at 9~15 months after PCI
EXPERIMENTALInterventions
In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9\~15 months after the procedure according to the practice pattern of each participating center.
In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.
Eligibility Criteria
You may qualify if:
- Subject was \> 19 years of age.
- Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.
- Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.
- Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).
- 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.
You may not qualify if:
- 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.
- Subject was unable to provide written informed consent or participate in long-term follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (11)
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Bundang CHA Hospital
Seongnam, South Korea
Seoul National University Bundang hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Eulji General Hospital
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
The Catholic university of Korea, ST. Vincent's Hospital
Suwon, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Related Publications (4)
Choi Y, Kang DY, Kim H, Lee J, Jo S, Ahn JM, Kim N, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW; POST-PCI Investigators. Role of routine surveillance stress testing in patients with or without imaging-guided or physiology-guided PCI. Heart. 2025 Oct 2:heartjnl-2025-326402. doi: 10.1136/heartjnl-2025-326402. Online ahead of print.
PMID: 41043864DERIVEDLee J, Kang DY, Kim H, Choi Y, Jo S, Ahn JM, Kim S, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW. Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome: A Secondary Analysis of the POST-PCI Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):770-780. doi: 10.1001/jamacardio.2024.1556.
PMID: 38922632DERIVEDLee JM, Kim H, Park YS, Jo HH, Lim SM, Lee J, Choi Y, Kang DY, Ahn JM, Kim S, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW; POST-PCI Investigators. Surveillance Stress Testing After Percutaneous Intervention for Patients With Multivessel or Left Main Coronary Disease. J Am Coll Cardiol. 2024 Mar 5;83(9):890-900. doi: 10.1016/j.jacc.2023.12.027.
PMID: 38418002DERIVEDPark DW, Kang DY, Ahn JM, Yun SC, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Yoon JH, Choi JW, Kim KS, Choi SW, Lee SN, Park SJ; POST-PCI Investigators. Routine Functional Testing or Standard Care in High-Risk Patients after PCI. N Engl J Med. 2022 Sep 8;387(10):905-915. doi: 10.1056/NEJMoa2208335. Epub 2022 Aug 28.
PMID: 36036496DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Duk-woo Park, MD
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 14, 2017
Study Start
November 15, 2017
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
April 5, 2022
Record last verified: 2022-04