High-Sensitivity Cardiac Troponin in Stable Ischemic Heart Disease

Study by Nicholas Marston, MD, and team shows that high-sensitivity cardiac troponin at any detectable concentration is linked to a higher risk of major cardiovascular events in patients with stable ischemic heart disease. The research, conducted through the PEGASUS-TIMI 54 trial, aimed to further understand this relationship in stable ischemic heart disease patients with a history of myocardial infarction. Results suggest that the levels of hsTnI provide valuable risk stratification in this population, potentially aiding in better management of these patients.

• Cardiac troponin
• Ischemic heart disease
• Cardiovascular events
• Nicholas Marston
• Risk stratification

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1. High-sensitivity Cardiac Troponin at Any Detectable Concentration Identifies Higher Risk of Major Cardiovascular Events in Patients with Stable Ischemic Heart Disease Nicholas Marston, MD TIMI Study Group Brigham and Women s Hospital Nicholas A. Marston, Marc P. Bonaca, Petr Jarolim, Deepak L. Bhatt, Philippe Gabriel Steg, Marc Cohen, Robert F. Storey, Per Johanson, Erica Goodrich, Steve D. Wiviott, Eugene Braunwald, Marc S. Sabatine, David A. Morrow

2. Disclosures Presenter Disclosure: None PEGASUS-TIMI 54 supported by a grant to BWH from AstraZeneca Biomarker testing received reagent support from Abbott Laboratories

3. Background Stable patients with a history of MI (SIHD) have a heterogeneous risk of recurrent major CV events hsTn is an emerging tool to better risk-stratify these patients PROVE IT-TIMI 22 TRA 2P - TIMI 50 CV Death/MI/Stroke hsTnI Subset of 4,162 patients 30 days out from ACS 15,833 patients Prior MI, stroke, or PAD Objective: To further explore this relationship in the stable ischemic heart disease population Bonaca MP, et al. J Am Coll Cardiol 2016;68:322-323. Eisen A, et al. Clin Chem 2017;63:307-315.

4. Methods Nested prospective cohort study (n= 8,635) from PEGASUS- TIMI 54 Randomized, double-blinded, placebo controlled trial of ticagrelor vs. placebo 55 years old SIHD with a MI 1-3 years prior to enrollment 1 high-risk feature: 65 yo, DM, 2 MIs, multivessel CAD, CKD Median F/U 33 months Primary endpoint (PEP): CV death, MI, or stroke All elements of PEP centrally adjudicated

5. Methods (2) Serum hsTnI (Abbott ARCHITECT) drawn at enrollment Limit-of-detection 2 ng/L MI cut-point 26 ng/L (99th percentile) hsTnI was analyzed as categorical variable using a priori categorieswithin the normal reference range, defined as: Undetectable (<2 ng/L) Low (2-6 ng/L) High (>6 ng/L) Population studies with risk thresholds between 5-7 ng/L WOSCOPS (Ford, et al. JACC. 2016) JUPITER (Everett, et al. Circ.2015) CAPS (Patterson, et al. IJC. 2015) ADVANCE (Iribarren, et al. Heart. 2016) BiomarCare (Blankenberg, et al. EHJ. 2016) HUNT (Omland, et al Clin Chem. 2015) FINNRISK (Neumann, et al. PLOS One. 2014) AGES-Rej (Thorstein, et al. Clin Chem. 2016)

6. hsTn Distribution 2 6 Total N 8,635 Median hsTnI (ng/L) Overall 4.2 [2.7,7.2] Female 3.6 [2.3,6.5] Male 4.3 [2.8,7.3] 920 (10.7%) Undetectable Detectable 7,715 (89.3%) 2-6 ng/L 5,028 (58.2%) >6 ng/L 2,687 (31.1%) <2 ng/L 920 (10.7%) Sex

7. Baseline Characteristics <2 2-6 >6 Baseline Characteristics by hsTnI Level (N=920) % (N=5028) % (N=2687) % Demographics Age (yrs) (median, IQR) Male History Hypertension Diabetes Mellitus History of CABG History of 2nd prior MI Peripheral Artery Disease Congestive Heart Failure eGFR <60 61 (55,66) 64 65 (58,70) 77 67 (60,73) 79 70 29 1 9 3 7 12 78 28 5 14 6 12 20 82 34 9 21 9 25 33 *All p-values <0.001

8. Results: Unadjusted Analysis CV Death, MI, Stroke by hsTnI Level (ng/L) hsTnI Level 20% >6 (n=2,687) 2-6 (n=5,028) CV Death, MI, Stroke (%) <2 (n=920) 15% 13.5%* 10% 6.0%^ 5% 2.8% 0% 0 120 240 360 480 600 Days 720 840 960 1080 * p<0.0001 vs. undetectable ^p=0.0002 vs. undetectable

9. Results: Unadjusted Analysis CV Death, MI, Stroke by hsTnI Level (ng/L) hsTnI Level 20% 26 (n=433, 5.0%) >6-<26 (n=2,254) 2-6 (n=5,028) 18.6%# CV Death, MI, Stroke (%) 15% <2 (n=920) 12.5%* 10% 6.0%^ 5% 2.8% 0% 0 120 240 360 480 600 720 840 960 1080 Days # p<0.0001 vs. undetectable * p<0.0001 vs. undetectable ^ p=0.0002 vs. undetectable

10. Components of PEP Cardiovascular and Coronary Death, MI and Stroke by hsTnI Level (ng/L) <2 2-6 >6 10 8.7 9 8 3 Year KM Rate (%) 7 6 5 4.3 4.1 4 2.8 3 2.5 2.3 2 1.1 1.0 0.6 1 0.3 0 0 0 Cardiovascular Death P<0.0001* Coronary Heart Death P<0.0001* Myocardial Infarction P<0.0001^ Stroke P<0.0001^ *>6 vs 2-6 ^P-Trend

11. PEP, Mortality, MI, and Stroke Adjusted Hazard Ratios by hsTnI Level P-Trend <0.0001 <0.0001 <0.0001 0.0007 Hazard Ratio Hazard Ratio Adjusted for congestive heart failure, hypertension, age >=75, diabetes mellitus, history of stroke, history of CABG, PAD, eGFR <60, current smoker

12. hsTnI and TRS 2P Score Incidence of Primary Endpoint at 3 Years by TRS 2 P score and hsTnI 18.7 n=1094 12.2 20 n=769 18 7.7 16 9.1 14 n=806 KM Rate (%) n=1218 12 6.1 10 4.1 n=1660 8 hsTnI (ng/L) >6 n=2107 6 2.9 2.4 2.3 2-6 4 n=481 n=292 n=135 2 <2 0 High* Int* Low* *P-Trend <0.0001 TRS 2 P Score

13. Ticagrelor by hsTnI 0.84 P=0.001 0.91 0.94 0.91 1.20 3.1

14. Conclusion hsTn is a strong independent predictor of recurrent major CV events in SIHD Gradient of risk is present at any detectable level As low as 2-6 ng/L hsTnI >6 ng/L present in nearly 1/3 of patients >10% 3-year risk of MACE Extrapolated 10-year risk of MACE = 45% In combination with TRS 2 P, hsTnI provides complementary information

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16. 99th Percentile by Sex Women Men 34 16 25% 25% >6-<34 >6-<16 2-6 2-6 21.5% CV Death, MI, Stroke (%) <2 <2 20% 20% 18.4% 15% 14.5% 15% 12.0% 10% 10% 7.1% 5.6% 3.3% 5% 5% 1.9% 0% 0% 0 120 240 360 480 600 720 840 960 1080 0 120 240 360 480 600 720 840 960 1080 Days Days Days Sex-specific 99th %ile URL: 34 ng/L in men and 16 ng/L in women

17. PEP, Mortality, MI, and Stroke Adjusted Hazard Ratios by hsTnI Level Adjusted for congestive heart failure, hypertension, age >=75, diabetes mellitus, history of stroke, history of CABG, PAD, eGFR <60, current smoker