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Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial.
J Am Coll Cardiol. 2016 Mar 22; 67(11):1289-97.JACC

Abstract

BACKGROUND

Patients with acute coronary syndrome (ACS), especially those receiving medical management without revascularization, are at high risk for spontaneous myocardial infarction (MI), but its frequency and predictors are unknown.

OBJECTIVES

This study sought to characterize spontaneous MI events in a randomized population during 30 months of follow-up and develop a prediction model for spontaneous MI to assign risk of spontaneous MI events in ACS populations.

METHODS

We analyzed data from the randomized TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medically manage Acute Coronary Syndromes) trial of aspirin plus prasugrel or clopidogrel following ACS. The trial included 9,326 patients with non-ST-segment elevation myocardial infarction (NSTEMI)/unstable angina (UA) who were managed medically without planned revascularization. Our study population included 9,294 patients. A multivariable Cox proportional hazards model was developed to determine predictors of time to first spontaneous MI event through 30 months. After model validation, we developed a calculator for model implementation.

RESULTS

Among 9,294 patients, 695 spontaneous MI events occurred over a median of 17 months, representing 94% of adjudicated MI events (n = 737). The Kaplan-Meier event rate of spontaneous MI through 30 months was 10.7%. The strongest predictors of spontaneous MI were older age, NSTEMI versus UA as index event, diabetes mellitus, no pre-randomization angiography, and higher baseline creatinine values. The model exhibited good predictive capabilities (c-index = 0.732) and had good calibration, especially for patients with low-to-moderate risk of spontaneous MI.

CONCLUSIONS

Spontaneous MI following a medically managed UA/NSTEMI event is common. Baseline characteristics can be used to predict subsequent risk of spontaneous MI in this population. These findings provide insight into the long-term natural history of medically managed UA/NSTEMI patients and could be used to optimize risk stratification and treatment of these patients. (A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects [TRILOGY ACS]; NCT00699998).

Authors+Show Affiliations

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address: renato.lopes@duke.edu.Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.Ospedale Maggiore di Parma, Parma, Italy.Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.Division of Cardiology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Canadian VIGOUR Centre, Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.Centre for Chronic Disease Control and Public Health Foundation of India, New Delhi, India.Cordoba National University, Cordoba, Argentina.Heart Institute-InCor, University of São Paulo Medical School, São Paulo, Brazil.Eli Lilly and Company, Indianapolis, Indiana.Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland, United Kingdom.Canadian VIGOUR Centre, Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26988949

Citation

Lopes, Renato D., et al. "Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: the TRILOGY ACS Trial." Journal of the American College of Cardiology, vol. 67, no. 11, 2016, pp. 1289-97.
Lopes RD, Leonardi S, Neely B, et al. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016;67(11):1289-97.
Lopes, R. D., Leonardi, S., Neely, B., Neely, M. L., Ohman, E. M., Ardissino, D., Hamm, C. W., Goodman, S. G., Bhatt, D. L., White, H. D., Prabhakaran, D., Martinez, F., Nicolau, J. C., Winters, K. J., Fox, K. A., Armstrong, P. W., & Roe, M. T. (2016). Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. Journal of the American College of Cardiology, 67(11), 1289-97. https://doi.org/10.1016/j.jacc.2016.01.034
Lopes RD, et al. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: the TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. PubMed PMID: 26988949.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. AU - Lopes,Renato D, AU - Leonardi,Sergio, AU - Neely,Benjamin, AU - Neely,Megan L, AU - Ohman,E Magnus, AU - Ardissino,Diego, AU - Hamm,Christian W, AU - Goodman,Shaun G, AU - Bhatt,Deepak L, AU - White,Harvey D, AU - Prabhakaran,Dorairaj, AU - Martinez,Felipe, AU - Nicolau,Jose C, AU - Winters,Kenneth J, AU - Fox,Keith A A, AU - Armstrong,Paul W, AU - Roe,Matthew T, PY - 2015/08/17/received PY - 2015/12/21/revised PY - 2016/01/05/accepted PY - 2016/3/19/entrez PY - 2016/3/19/pubmed PY - 2016/8/3/medline KW - acute coronary syndrome KW - risk prediction KW - spontaneous myocardial infarction SP - 1289 EP - 97 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 67 IS - 11 N2 - BACKGROUND: Patients with acute coronary syndrome (ACS), especially those receiving medical management without revascularization, are at high risk for spontaneous myocardial infarction (MI), but its frequency and predictors are unknown. OBJECTIVES: This study sought to characterize spontaneous MI events in a randomized population during 30 months of follow-up and develop a prediction model for spontaneous MI to assign risk of spontaneous MI events in ACS populations. METHODS: We analyzed data from the randomized TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medically manage Acute Coronary Syndromes) trial of aspirin plus prasugrel or clopidogrel following ACS. The trial included 9,326 patients with non-ST-segment elevation myocardial infarction (NSTEMI)/unstable angina (UA) who were managed medically without planned revascularization. Our study population included 9,294 patients. A multivariable Cox proportional hazards model was developed to determine predictors of time to first spontaneous MI event through 30 months. After model validation, we developed a calculator for model implementation. RESULTS: Among 9,294 patients, 695 spontaneous MI events occurred over a median of 17 months, representing 94% of adjudicated MI events (n = 737). The Kaplan-Meier event rate of spontaneous MI through 30 months was 10.7%. The strongest predictors of spontaneous MI were older age, NSTEMI versus UA as index event, diabetes mellitus, no pre-randomization angiography, and higher baseline creatinine values. The model exhibited good predictive capabilities (c-index = 0.732) and had good calibration, especially for patients with low-to-moderate risk of spontaneous MI. CONCLUSIONS: Spontaneous MI following a medically managed UA/NSTEMI event is common. Baseline characteristics can be used to predict subsequent risk of spontaneous MI in this population. These findings provide insight into the long-term natural history of medically managed UA/NSTEMI patients and could be used to optimize risk stratification and treatment of these patients. (A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects [TRILOGY ACS]; NCT00699998). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/26988949/Spontaneous_MI_After_Non_ST_Segment_Elevation_Acute_Coronary_Syndrome_Managed_Without_Revascularization:_The_TRILOGY_ACS_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(16)00371-5 DB - PRIME DP - Unbound Medicine ER -