Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention

Pierluigi Tricoci; L. Kristin Newby; Robert M. Clare; Sergio Leonardi; C. Michael Gibson; Robert P. Giugliano; Paul W. Armstrong; Frans Van de Werf; Gilles Montalescot; David J. Moliterno; Claes Held; Philip E. Aylward; Lars Wallentin; Robert A. Harrington; Eugene Braunwald; Kenneth W. Mahaffey; Harvey D. White

doi:10.1016/j.jcin.2018.02.006

Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention

Pierluigi Tricoci
, L. Kristin Newby
, Robert M. Clare
, Sergio Leonardi
, C. Michael Gibson
, Robert P. Giugliano
, Paul W. Armstrong
, Frans Van de Werf
, Gilles Montalescot
, David J. Moliterno
, Claes Held
, Philip E. Aylward
, Lars Wallentin
, Robert A. Harrington
, Eugene Braunwald
, Kenneth W. Mahaffey
, Harvey D. White

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

31 Scopus citations

Abstract

Objectives: In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed. Background: The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established. Methods: In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared. Results: Altogether, 2.0% of patients met third universal definition of PCI-related MI criteria, and 1.2% met SCAI criteria. One-year mortality was 3.3% with the third universal definition (hazard ratio: 1.96; 95% confidence interval: 1.24 to 3.10) and 5.3% with SCAI criteria (hazard ratio: 2.79; 95% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate (κ = 0.53). Conclusions: The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography.

Original language	English
Pages (from-to)	856-864
Number of pages	9
Journal	JACC: Cardiovascular Interventions
Volume	11
Issue number	9
DOIs	https://doi.org/10.1016/j.jcin.2018.02.006
State	Published - May 14 2018

Bibliographical note

Publisher Copyright:
© 2018 American College of Cardiology Foundation

Funding

The TRACER trial was supported by Merck. The EARLY ACS trial was supported by Schering-Plough and Millennium Pharmaceuticals. Dr. Tricoci has a consultant agreement and research grant from Merck and CSL and a research grant from Sanofi. Dr. Newby has received research support from Bristol-Myers Squibb, GlaxoSmithKline, Google Life Sciences (Verily), NHLBI, MURDOCK Study, and NIH; and consulting or other services (including CME) for American Heart Association, AstraZeneca HCF, CAMC Health Education & Research Institute, Center for Human Genetics, North Carolina State University, Medscape, LLC/TheHeart.org, Metanomics, NIH, Philips, Roche Diagnostic Corp., Society of CV Patient Care, and University of Alberta. Dr. Gibson reports serving as the Chief Executive Officer at the Baim Institute for Clinical Research; present research/grant funding from Angel Medical Corporation, Bayer Corp, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson Corporation, Portola Pharmaceuticals; consulting and peer-to-peer communication for Amarin Pharama, Amgen, Arena Pharmaceuticals, Bayer Corporation, Boehringer Ingelheim, Boston Clinical Research Institute, Cardiovascular Research Foundation, Chiesi, CSL Behring, Eli Lilly, Gilead Sciences, Inc., Janssen Pharmaceuticals, Johnson & Johnson Corporation, The Medicines Company, Merck, Novo Nordisk, Pfizer, Pharma Mar, Portola Pharmaceuticals, Sanofi, Somahlution, St. Francis Hospital, Vereson Corportation, WebMD; and royalties as a contributor for UpToDate in Cardiovascular Medicine. Dr. Giugliano has received honoraria from Merck-Schering Plough and from Daiichi Sankyo as a consultant and for continuing medical education lectures; research grant funding for EARLY ACS through the TIMI Study Group from Merck-Schering Plough, and from Daiichi Sankyo for a trial with a novel anticoagulant. Dr. Armstrong has received research support from Merck, Bayer, Sanofi, Recherche & Développement, and CSL Limited; consulting or other services for AstraZeneca, Merck, Bayer, Novartis, Mast Therapeutics, Cardiome Pharma Corp., and CSL Limited. Dr. Van de Werf has received a research grant and honoraria for lectures and advisory board membership from Merck. Dr. Montalescot has received research funds for his institution or fees from Abbott, Amgen, Actelion, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women's Hospital, Cardiovascular Research Foundation, Daiichi Sankyo, Idorsia, Lilly, Europa, Elsevier, Fédération Française de Cardiologie, ICAN, Medtronic, Journal of the American College of Cardiology, Lead-Up, Menarini, Merck Sharpe & Dohme, Novo-Nordisk, Pfizer, Sanofi, Servier, The Mount Sinai School, TIMI Study Group, and WebMD. Dr. Held has received institutional research grants from AstraZeneca, GlaxoSmithKline, Pfizer/Bristol-Myers Squibb, Roche, and Schering-Plough (now Merck); and is a consultant for AstraZeneca. Dr. Aylward has received research grants from Merck, AstraZeneca, Sanofi, and GlaxoSmithKline; and has received honoraria for Speakers Bureau and advisory board membership from AstraZeneca, Eli Lilly, Boehringer Ingelheim, Bayer Johnson & Johnson, Servier, and Bristol-Myers Squibb. Dr. Wallentin has received research grants from AstraZeneca, Merck, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, and GlaxoSmithKline; Speakers Bureau and lecture fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline, and Merck; honoraria from Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline, and Merck; is a consultant or advisory board member for Merck, Regado Biosciences, Evolva, Portola, CSL Behring, Athera Biotechnologies, Boehringer Ingelheim, AstraZeneca, GlaxoSmithKline, and Bristol-Myers Squibb/Pfizer; and has received travel support from Bristol-Myers Squibb/Pfizer. Dr. Harrington has received consulting fees and honoraria from Adverse Events, Amgen, Daiichi-Lilly, Gilead Sciences, Janssen Research & Development, Medtronic, Merck, Novartis Corporation, The Medicines Company, Vida Health, Vox Media, and WebMD; has received research grants from AstraZeneca, Bristol-Myers Squibb, CSL Behring, GlaxoSmithKline, Merck, Portola, Sanofi, and The Medicines Company; has ownership interest and is a partner or principal at Element Science and MyoKardia; is an officer, a director, a trustee, or holds another fiduciary role with Evidint and Scanadu; is a member of the Data Safety Monitoring Board for Regado; and has is an officer, director, trustee, or holds another fiduciary role with the American Heart Association. Dr. Braunwald has received consulting fees, lecture fees, and grant support from Eli Lilly, Johnson & Johnson, Merck, and Bayer. Dr. Mahaffey reports research support from Afferent, Amgen, Apple, Inc., AstraZeneca, Cardiva Medical, Inc., Daiichi Sankyo, Ferring, Google (Verily), Johnson & Johnson, Luitpold, Medtronic, Merck, Novartis, Sanofi, St. Jude Medical, Tenax; consulting or other services (including CME) forAblynx, AstraZeneca, Baim Institute, Boehringer Ingelheim, Bristol-Myers Squibb, Cardiometabolic Health Congress, Elsevier, GlaxoSmithKline, Johnson & Johnson, Medergy, Medscape, Merck, Mitsubishi, Myokardia, Novartis, Oculeve, Portola, Radiometer, Springer Publishing, Theravance, UCSF, WebMD; and has equity in BioPrint Fitness. Dr. White has received research grants from Sanofi, Eli Lilly, the National Institutes of Health, Merck Sharpe & Dohme, AstraZeneca, GlaxoSmithKline, and Daiichi Sankyo Pharma Development; and has received consulting fees from AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Funders
Athera Biotechnologies
Bayer/Johnson & Johnson
Merck-Schering Plough
Schering-Plough and Millennium Pharmaceuticals
Speakers Bureau of AstraZeneca
National Institutes of Health (NIH)
Boehringer-Ingelheim
Bristol-Myers Squibb
Eli Lilly and Company
Pfizer
AstraZeneca
GlaxoSmithKline
Johnson and Johnson Pharmaceutical Research and Development
Merck
Sanofi
CSL Behring GmbH
Merck Sharp and Dohme
Bayer Fund
Daiichi Sankyo Company, Limited
Servier Institute
CSL Limited

Keywords

acute coronary syndrome(s)
definitions
myocardial infarction

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jcin.2018.02.006

Cite this

Tricoci, P., Newby, L. K., Clare, R. M., Leonardi, S., Gibson, C. M., Giugliano, R. P., Armstrong, P. W., Van de Werf, F., Montalescot, G., Moliterno, D. J., Held, C., Aylward, P. E., Wallentin, L., Harrington, R. A., Braunwald, E., Mahaffey, K. W., & White, H. D. (2018). Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention. JACC: Cardiovascular Interventions, 11(9), 856-864. https://doi.org/10.1016/j.jcin.2018.02.006

@article{60daf62ef60d401b908e0ad14c8338f6,

title = "Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention",

abstract = "Objectives: In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed. Background: The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established. Methods: In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared. Results: Altogether, 2.0\% of patients met third universal definition of PCI-related MI criteria, and 1.2\% met SCAI criteria. One-year mortality was 3.3\% with the third universal definition (hazard ratio: 1.96; 95\% confidence interval: 1.24 to 3.10) and 5.3\% with SCAI criteria (hazard ratio: 2.79; 95\% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate (κ = 0.53). Conclusions: The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography.",

keywords = "acute coronary syndrome(s), definitions, myocardial infarction",

author = "Pierluigi Tricoci and Newby, \{L. Kristin\} and Clare, \{Robert M.\} and Sergio Leonardi and Gibson, \{C. Michael\} and Giugliano, \{Robert P.\} and Armstrong, \{Paul W.\} and \{Van de Werf\}, Frans and Gilles Montalescot and Moliterno, \{David J.\} and Claes Held and Aylward, \{Philip E.\} and Lars Wallentin and Harrington, \{Robert A.\} and Eugene Braunwald and Mahaffey, \{Kenneth W.\} and White, \{Harvey D.\}",

note = "Publisher Copyright: {\textcopyright} 2018 American College of Cardiology Foundation",

year = "2018",

month = may,

day = "14",

doi = "10.1016/j.jcin.2018.02.006",

language = "English",

volume = "11",

pages = "856--864",

number = "9",

}

Tricoci, P, Newby, LK, Clare, RM, Leonardi, S, Gibson, CM, Giugliano, RP, Armstrong, PW, Van de Werf, F, Montalescot, G, Moliterno, DJ, Held, C, Aylward, PE, Wallentin, L, Harrington, RA, Braunwald, E, Mahaffey, KW & White, HD 2018, 'Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention', JACC: Cardiovascular Interventions, vol. 11, no. 9, pp. 856-864. https://doi.org/10.1016/j.jcin.2018.02.006

TY - JOUR

T1 - Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention

AU - Tricoci, Pierluigi

AU - Newby, L. Kristin

AU - Clare, Robert M.

AU - Leonardi, Sergio

AU - Gibson, C. Michael

AU - Giugliano, Robert P.

AU - Armstrong, Paul W.

AU - Van de Werf, Frans

AU - Montalescot, Gilles

AU - Moliterno, David J.

AU - Held, Claes

AU - Aylward, Philip E.

AU - Wallentin, Lars

AU - Harrington, Robert A.

AU - Braunwald, Eugene

AU - Mahaffey, Kenneth W.

AU - White, Harvey D.

PY - 2018/5/14

Y1 - 2018/5/14

N2 - Objectives: In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed. Background: The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established. Methods: In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared. Results: Altogether, 2.0% of patients met third universal definition of PCI-related MI criteria, and 1.2% met SCAI criteria. One-year mortality was 3.3% with the third universal definition (hazard ratio: 1.96; 95% confidence interval: 1.24 to 3.10) and 5.3% with SCAI criteria (hazard ratio: 2.79; 95% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate (κ = 0.53). Conclusions: The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography.

AB - Objectives: In 13,038 patients with non–ST-segment elevation acute coronary syndrome undergoing index percutaneous coronary intervention (PCI) in the EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) and TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trials, the relationship between PCI-related myocardial infarction (MI) and 1-year mortality was assessed. Background: The definition of PCI-related MI is controversial. The third universal definition of PCI-related MI requires cardiac troponin >5 times the 99th percentile of the normal reference limit from a stable or falling baseline and PCI-related clinical or angiographic complications. The definition from the Society for Cardiovascular Angiography and Interventions (SCAI) requires creatine kinase–MB elevation >10 times the upper limit of normal (or 5 times if new electrocardiographic Q waves are present). Implications of these definitions on prognosis, prevalence, and implementation are not established. Methods: In our cohort of patients undergoing PCI, PCI-related MIs were classified using the third universal type 4a MI definition and SCAI criteria. In the subgroup of patients included in the angiographic core laboratory (ACL) substudy of EARLY ACS (n = 1,401) local investigator– versus ACL-reported angiographic complications were compared. Results: Altogether, 2.0% of patients met third universal definition of PCI-related MI criteria, and 1.2% met SCAI criteria. One-year mortality was 3.3% with the third universal definition (hazard ratio: 1.96; 95% confidence interval: 1.24 to 3.10) and 5.3% with SCAI criteria (hazard ratio: 2.79; 95% confidence interval: 1.69 to 4.58; p < 0.001). Agreement between ACL and local investigators in detecting angiographic complications during PCI was overall moderate (κ = 0.53). Conclusions: The third universal definition of MI and the SCAI definition were both associated with significant risk for mortality at 1 year. Suboptimal concordance was observed between ACL and local investigators in identifying patients with PCI complications detected on angiography.

KW - acute coronary syndrome(s)

KW - definitions

KW - myocardial infarction

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DO - 10.1016/j.jcin.2018.02.006

M3 - Article

C2 - 29747915

AN - SCOPUS:85046454117

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VL - 11

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EP - 864

JO - JACC: Cardiovascular Interventions

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IS - 9

ER -

Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

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