Author + information
- Received October 19, 2017
- Revision received February 7, 2018
- Accepted February 8, 2018
- Published online May 2, 2018.
- Pierluigi Tricoci, MD, MHS, PhDa,∗ (, )
- L. Kristin Newby, MD, MHSa,
- Robert M. Clare, MSa,
- Sergio Leonardi, MD, MHSb,
- C. Michael Gibson, MD, MS, MAc,
- Robert P. Giugliano, MD, MScd,
- Paul W. Armstrong, MDe,
- Frans Van de Werf, MDf,
- Gilles Montalescot, MD, PhDg,
- David J. Moliterno, MDh,
- Claes Held, MD, PhDi,
- Philip E. Aylward, MDj,
- Lars Wallentin, MD, PhDi,
- Robert A. Harrington, MDk,
- Eugene Braunwald, MDd,
- Kenneth W. Mahaffey, MDk and
- Harvey D. White, DScl
- aDuke Clinical Research Institute, Durham, North Carolina
- bFondazione IRCCS Policlinico San Matteo, Pavia, Italy
- cBeth Israel Deaconess Medical Center, Boston, Massachusetts
- dTIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
- eDivision of Cardiology, University of Alberta, Edmonton, Alberta, Canada
- fDepartment of Cardiology, University of Leuven, Leuven, Belgium
- gSorbonne Université Paris 06, ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière (AP-HP), Paris, France
- hGill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, Kentucky
- iDepartment of Medical Sciences, Cardiology, Uppsala University, Uppsala Clinical Research Center, Uppsala, Sweden
- jSouth Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, Australia
- kDepartment of Medicine, Stanford University, Stanford, California
- lGreen Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
- ↵∗Address for correspondence:
Dr. Pierluigi Tricoci, Duke Clinical Research Institute, Box 3850, 2400 Pratt Street, Durham, North Carolina 27705.
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. (Trial to Assess the Effects of Vorapaxar [SCH 530348; MK-5348] in Preventing Heart Attack and Stroke in Participants With Acute Coronary Syndrome [TRA·CER] [Study P04736]; NCT00527943; EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome [Study P03684AM2]; NCT00089895)
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.
- Received October 19, 2017.
- Revision received February 7, 2018.
- Accepted February 8, 2018.
- 2018 American College of Cardiology Foundation
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