Prognostic implications of biomarker assessments in patients with type 2 diabetes at high cardiovascular risk: A secondary analysis of a randomized clinical trial

JAMA Cardiology

Volumn 1, Issue 9, 2016, Pages 989-998

  Scirica, Benjamin M ^a   Bhatt, Deepak L ^a   Braunwald, Eugene ^a   Raz, Itamar ^b   Cavender, Matthew A ^a   Im, KyungAh ^a   Mosenzon, Ofri ^b   Udell, Jacob A ^c,d   Hirshberg, Boaz ^e   Pollack, Pia S ^e   Steg, Ph Gabriel ^f,g,h   Jarolim, Petr ⁱ   Morrow, David A ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^c WOMEN S COLLEGE HOSPITAL   (Canada)

^d UNIVERSITY HEALTH NETWORK   (Canada)

^e ASTRAZENECA   (United Kingdom)

^f ROYAL BROMPTON HOSPITAL   (United Kingdom)

^g Site Xavier Bichat and Département Hospitalo Universitaire Fibrosis Inflammation and Remodeling   (France)

^h BICHAT HOSPITAL   (France)

ⁱ BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; C REACTIVE PROTEIN; PLACEBO; SAXAGLIPTIN; TROPONIN T;

ADULT; AGED; ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MORTALITY; FEMALE; HEART FAILURE; HEART INFARCTION; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); NON INSULIN DEPENDENT DIABETES MELLITUS; OUTPATIENT; PRIORITY JOURNAL; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC);

EID: 85018315502     PISSN: 23806583     EISSN: 23806591     Source Type: Journal    
DOI: 10.1001/jamacardio.2016.3030     Document Type: Article

References (35)

1. Donahoe SM, Stewart GC, McCabe CH, et al. Diabetes and mortality following acute coronary syndromes. JAMA. 2007;298(7):765-775.
2. Sarwar N, Gao P, Seshasai SR, et al; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010;375(9733): 2215-2222.
3. Bhatt DL, Eagle KA, Ohman EM, et al; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010;304(12):1350-1357.
4. Cavender MA, Steg PG, Smith SC Jr, et al; REACH Registry Investigators. Impact of diabetes mellitus on hospitalization for heart failure, cardiovascular events, and death: outcomes at 4 years from the Reduction of Atherothrombosis for Continued Health (REACH) Registry. Circulation. 2015;132(10): 923-931.
5. Scirica BM, Bhatt DL, Braunwald E, et al. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011; 162(5):818-825.e6.
6. Scirica BM, Braunwald E, Raz I, et al; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014;130(18):1579-1588.
7. Scirica BM, Bhatt DL, Braunwald E, et al; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317-1326.
8. Hicks KA, Tcheng JE, Bozkurt B, et al. 2014 ACC/AHA key data elements and definitions for cardiovascular endpoint events in clinical trials: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards) [published correction appears in J Am Coll Cardiol. 2015;66(8):982]. J Am Coll Cardiol. 2015;66(4): 403-469.
9. proBNP II [package insert]. Indianapolis, IN: Roche Diagnostics; 2010.
10. Giannitsis E, Becker M, Kurz K, Hess G, Zdunek D, Katus HA. High-sensitivity cardiac troponin T for early prediction of evolving non-ST-segment elevation myocardial infarction in patients with suspected acute coronary syndrome and negative troponin results on admission. Clin Chem. 2010;56(4):642-650.
11. Gore MO, Seliger SL, Defilippi CR, et al. Age- and sex-dependent upper reference limits for the high-sensitivity cardiac troponin T assay. J Am Coll Cardiol. 2014;63(14):1441-1448.
12. Pearson TA, Mensah GA, Alexander RW, et al; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: a statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003;107 (3):499-511.
13. Harrell FE Jr, Lee KL, Califf RM, Pryor DB, Rosati RA. Regression modelling strategies for improved prognostic prediction. Stat Med. 1984;3(2):143-152.
14. Pencina MJ, D’Agostino RB Sr, D’Agostino RB Jr, Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med. 2008;27(2): 157-172.
15. Pencina MJ, D’Agostino RB, Pencina KM, Janssens AC, Greenland P. Interpreting incremental value of markers added to risk prediction models. Am J Epidemiol. 2012;176(6):473-481.
16. Thygesen K, Alpert JS, Jaffe AS, et al; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Biomarker Subcommittee; ECG Subcommittee; Imaging Subcommittee; Classification Subcommittee; Intervention Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; Trials & Registries Subcommittee; ESC Committee for Practice Guidelines (CPG); Document Reviewers. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60(16):1581-1598.
17. Everett BM, Cook NR, Magnone MC, et al. Sensitive cardiac troponin T assay and the risk of incident cardiovascular disease in women with and without diabetes mellitus: the Women’s Health Study. Circulation. 2011;123(24):2811-2818.
18. Omland T, de Lemos JA, Sabatine MS, et al; Prevention of Events with Angiotensin Converting Enzyme Inhibition (PEACE) Trial Investigators. A sensitive cardiac troponin T assay in stable coronary artery disease. N Engl J Med. 2009;361(26):2538-2547.
19. Yiu KH, Lau KK, Zhao CT, et al. Predictive value of high-sensitivity troponin-I for future adverse cardiovascular outcome in stable patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2014;13:63.
20. Everett BM, Brooks MM, Vlachos HE, Chaitman BR, Frye RL, Bhatt DL; BARI 2D Study Group. Troponin and cardiac events in stable ischemic heart disease and diabetes. N Engl J Med. 2015;373 (7):610-620.
21. Selvin E, Lazo M, Chen Y, et al. Diabetes mellitus, prediabetes, and incidence of subclinical myocardial damage. Circulation. 2014;130(16):1374-1382.
22. Shah AD, Langenberg C, Rapsomaniki E, et al. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1·9 million people. Lancet Diabetes Endocrinol. 2015;3(2):105-113.
23. Fox CS, Golden SH, Anderson C, et al; American Heart Association Diabetes Committee of the Council on Lifestyle and Cardiometabolic Health, Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, Council on Quality of Care and Outcomes Research, and the American Diabetes Association. Update on prevention of cardiovascular disease in adults with type 2 diabetes mellitus in light of recent evidence: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2015;132(8):691-718.
24. Omland T, Sabatine MS, Jablonski KA, et al; PEACE Investigators. Prognostic value of B-type natriuretic peptides in patients with stable coronary artery disease: the PEACE Trial. J Am Coll Cardiol. 2007;50(3):205-214.
25. Bruno G, Landi A, Barutta F, et al. N-terminal probrain natriuretic peptide is a stronger predictor of cardiovascular mortality than C-reactive protein and albumin excretion rate in elderly patients with type 2 diabetes: the Casale Monferrato population-based study. Diabetes Care. 2013;36(9): 2677-2682.
26. Tarnow L, Gall MA, Hansen BV, Hovind P, Parving HH. Plasma N-terminal pro-B-type natriuretic peptide and mortality in type 2 diabetes. Diabetologia. 2006;49(10):2256-2262.
27. Gerstein HC, Paré G, McQueen MJ, et al; Outcome Reduction With Initial Glargine Intervention Trial Investigators. Identifying novel biomarkers for cardiovascular events or death in people with dysglycemia. Circulation. 2015;132(24): 2297-2304.
28. Sabatine MS, Morrow DA, de Lemos JA, et al. Multimarker approach to risk stratification in non-ST elevation acute coronary syndromes: simultaneous assessment of troponin I, C-reactive protein, and B-type natriuretic peptide. Circulation. 2002;105(15):1760-1763.
29. Scirica BM, Sabatine MS, Jarolim P, et al. Assessment of multiple cardiac biomarkers in non-ST-segment elevation acute coronary syndromes: observations from the MERLIN-TIMI 36 trial. Eur Heart J. 2011;32(6):697-705.
30. Hlatky MA, Greenland P, Arnett DK, et al; American Heart Association Expert Panel on Subclinical Atherosclerotic Diseases and Emerging Risk Factors and the Stroke Council. Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association [published correction appears in Circulation. 2009;119(25):e606]. Circulation. 2009;119(17):2408-2416.
31. McGeechan K, Macaskill P, Irwig L, Liew G, Wong TY. Assessing new biomarkers and predictive models for use in clinical practice: a clinician’s guide. Arch Intern Med. 2008;168(21):2304-2310.
32. Troughton RW, Frampton CM, Brunner-LaRocca HP, et al. Effect of B-type natriuretic peptide-guided treatment of chronic heart failure on total mortality and hospitalization: an individual patient meta-analysis. Eur Heart J. 2014;35(23):1559-1567.
33. Huelsmann M, Neuhold S, Resl M, et al. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial. J Am Coll Cardiol. 2013; 62(15):1365-1372.
34. Kernan WN, Viscoli CM, Furie KL, et al; IRIS Trial Investigators. Pioglitazone after ischemic stroke or transient ischemic attack. N Engl J Med. 2016;374 (14):1321-1331.
35. Zinman B, Wanner C, Lachin JM, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-2128.