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Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention (POST PCI)

Primary Purpose

Coronary Artery Disease With Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
routine stress testing
No Routine stress testing
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease With Myocardial Infarction focused on measuring noninvasive stress testing, high risk, unstable angina, PCI

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject was > 19 years of age.
  2. 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.

  3. 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

  4. 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.

Exclusion Criteria:

  1. Cardiogenic shock at the index admission
  2. Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
  3. Pregnant and/or lactating women.
  4. Concurrent medical condition with a life expectancy of less than 1 years
  5. 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.

Sites / Locations

  • Gangwon National Univ. Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Chungnam National University Hospital
  • Bundang CHA Hospital
  • Seoul National University Bundang hospital
  • Asan Medical Center
  • Eulji General Hospital
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • The Catholic university of Korea, ST. Vincent's Hospital
  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Routine stress testing after PCI

Routine stress testing at 9~15 months after PCI

Arm Description

Outcomes

Primary Outcome Measures

composite of major cardiovascular events
a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.

Secondary Outcome Measures

Death
Myocardial infarction
Unstable angina hospitalization
Death or myocardial infarction
Any hospitalization
cardiac cause vs. noncardiac cause
Invasive catheterization
Repeat revascularization procedure
Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven.

Full Information

First Posted
July 13, 2017
Last Updated
April 3, 2022
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03217877
Brief Title
Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention
Acronym
POST PCI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease With Myocardial Infarction
Keywords
noninvasive stress testing, high risk, unstable angina, PCI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Routine stress testing after PCI
Arm Type
Active Comparator
Arm Title
Routine stress testing at 9~15 months after PCI
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
routine stress testing
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
No Routine stress testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
composite of major cardiovascular events
Description
a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Death
Time Frame
2 year
Title
Myocardial infarction
Time Frame
2 year
Title
Unstable angina hospitalization
Time Frame
2 year
Title
Death or myocardial infarction
Time Frame
2 year
Title
Any hospitalization
Description
cardiac cause vs. noncardiac cause
Time Frame
2 year
Title
Invasive catheterization
Time Frame
2 year
Title
Repeat revascularization procedure
Description
Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-woo Park, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangwon National Univ. Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Bundang CHA Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National University Bundang hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic university of Korea, ST. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36036496
Citation
Park 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.
Results Reference
derived

Learn more about this trial

Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention

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