Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial

Yong Hoon Yoon; Jung Min Ahn; Do Yoon Kang; Hanbit Park; Sang Cheol Cho; Pil Hyung Lee; Seung Ho Hur; Won Jang Kim; Chul Soo Park; Bong Ki Lee; Jung Won Suh; Jung Han Yoon; Jae Woong Choi; Ki Sik Kim; Si Wan Choi; Su Nam Lee; Seung Jung Park; Duk Woo Park

doi:10.1016/j.ahj.2020.03.019

Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial

Yong Hoon Yoon, Jung Min Ahn, Do Yoon Kang, Hanbit Park, Sang Cheol Cho, Pil Hyung Lee, Seung Ho Hur, Won Jang Kim, Chul Soo Park, Bong Ki Lee, Jung Won Suh, Jung Han Yoon, Jae Woong Choi, Ki Sik Kim, Si Wan Choi, Su Nam Lee, Seung Jung Park, Duk Woo Park

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Background: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. Methods: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. Results: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. Conclusion: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

Original language	English
Pages (from-to)	156-165
Number of pages	10
Journal	American Heart Journal
Volume	224
DOIs	https://doi.org/10.1016/j.ahj.2020.03.019
State	Published - Jun 2020

Bibliographical note

Funding Information:
The POST-PCI trial is an investigator-initiated trial partly funded by the CardioVascular Research Foundation (CVRF, Seoul, Korea) and the Daewoong Pharmaceutical (Seoul, Korea). It is conducted under the supervision of an executive committee that developed the protocol and oversees trial execution, the independent database, and analysis of the results and publication. The executive committee approved the final trial design and protocol issued to the Data and Safety Monitoring Board (DSMB) and the clinical sites. A steering committee of investigators provides operational expertise and advises the executive committee. Overall, operational oversight of the study is performed through the Clinical Research Center in Asan Medical Center, Seoul, Korea. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.

Publisher Copyright:
© 2020 Elsevier Inc.

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10.1016/j.ahj.2020.03.019

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Yoon, Y. H., Ahn, J. M., Kang, D. Y., Park, H., Cho, S. C., Lee, P. H., Hur, S. H., Kim, W. J., Park, C. S., Lee, B. K., Suh, J. W., Yoon, J. H., Choi, J. W., Kim, K. S., Choi, S. W., Lee, S. N., Park, S. J., & Park, D. W. (2020). Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial. American Heart Journal, 224, 156-165. https://doi.org/10.1016/j.ahj.2020.03.019

@article{8ea280640bd14839a45df192dfdae2a2,

title = "Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial",

abstract = "Background: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. Methods: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. Results: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. Conclusion: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.",

author = "Yoon, {Yong Hoon} and Ahn, {Jung Min} and Kang, {Do Yoon} and Hanbit Park and Cho, {Sang Cheol} and Lee, {Pil Hyung} and Hur, {Seung Ho} and Kim, {Won Jang} and Park, {Chul Soo} and Lee, {Bong Ki} and Suh, {Jung Won} and Yoon, {Jung Han} and Choi, {Jae Woong} and Kim, {Ki Sik} and Choi, {Si Wan} and Lee, {Su Nam} and Park, {Seung Jung} and Park, {Duk Woo}",

note = "Funding Information: The POST-PCI trial is an investigator-initiated trial partly funded by the CardioVascular Research Foundation (CVRF, Seoul, Korea) and the Daewoong Pharmaceutical (Seoul, Korea). It is conducted under the supervision of an executive committee that developed the protocol and oversees trial execution, the independent database, and analysis of the results and publication. The executive committee approved the final trial design and protocol issued to the Data and Safety Monitoring Board (DSMB) and the clinical sites. A steering committee of investigators provides operational expertise and advises the executive committee. Overall, operational oversight of the study is performed through the Clinical Research Center in Asan Medical Center, Seoul, Korea. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents. Publisher Copyright: {\textcopyright} 2020 Elsevier Inc.",

year = "2020",

month = jun,

doi = "10.1016/j.ahj.2020.03.019",

language = "English",

volume = "224",

pages = "156--165",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Elsevier Inc.",

}

Yoon, YH, Ahn, JM, Kang, DY, Park, H, Cho, SC, Lee, PH, Hur, SH, Kim, WJ, Park, CS, Lee, BK, Suh, JW, Yoon, JH, Choi, JW, Kim, KS, Choi, SW, Lee, SN, Park, SJ & Park, DW 2020, 'Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial', American Heart Journal, vol. 224, pp. 156-165. https://doi.org/10.1016/j.ahj.2020.03.019

TY - JOUR

T1 - Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention

T2 - Rationale and design of POST-PCI trial

AU - Yoon, Yong Hoon

AU - Ahn, Jung Min

AU - Kang, Do Yoon

AU - Park, Hanbit

AU - Cho, Sang Cheol

AU - Lee, Pil Hyung

AU - Hur, Seung Ho

AU - Kim, Won Jang

AU - Park, Chul Soo

AU - Lee, Bong Ki

AU - Suh, Jung Won

AU - Yoon, Jung Han

AU - Choi, Jae Woong

AU - Kim, Ki Sik

AU - Choi, Si Wan

AU - Lee, Su Nam

AU - Park, Seung Jung

AU - Park, Duk Woo

N1 - Funding Information: The POST-PCI trial is an investigator-initiated trial partly funded by the CardioVascular Research Foundation (CVRF, Seoul, Korea) and the Daewoong Pharmaceutical (Seoul, Korea). It is conducted under the supervision of an executive committee that developed the protocol and oversees trial execution, the independent database, and analysis of the results and publication. The executive committee approved the final trial design and protocol issued to the Data and Safety Monitoring Board (DSMB) and the clinical sites. A steering committee of investigators provides operational expertise and advises the executive committee. Overall, operational oversight of the study is performed through the Clinical Research Center in Asan Medical Center, Seoul, Korea. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents. Publisher Copyright: © 2020 Elsevier Inc.

PY - 2020/6

Y1 - 2020/6

N2 - Background: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. Methods: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. Results: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. Conclusion: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

AB - Background: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. Methods: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. Results: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. Conclusion: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

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U2 - 10.1016/j.ahj.2020.03.019

DO - 10.1016/j.ahj.2020.03.019

M3 - Article

C2 - 32402702

AN - SCOPUS:85084637289

SN - 0002-8703

VL - 224

SP - 156

EP - 165

JO - American Heart Journal

JF - American Heart Journal

ER -

Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial

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