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Circulation 2008;118:632-638

Prevalence and Prognostic Significance of Preprocedural Cardiac Troponin Elevation Among Patients With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: Results From The EVENT Registry.

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Circulation 2008;118:632-638

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  1. Prevalence and Prognostic Significance of Preprocedural Cardiac Troponin Elevation Among Patients With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: Results From The EVENT Registry Allen Jeremias, Neal Kleiman, Deborah Nassif, Wen-Hua Hsieh, Michael Pencina, Kelly Maresh, Manish Parikh, Donald Cutlip, Ron Waksman, Steven Goldberg, Peter Berger, David Cohen Circulation 2008;118:632-638

  2. Presenter Disclosure Information The EVENT Registry is supported by research grants from Schering-Plough and Millennium Pharmaceuticals None of the authors have any disclosures with respect to this work

  3. Background • Elevated cardiac troponin well established as predictor of adverse outcomes among patients with ACS • Troponin elevation has been described in a number of disease states in the absence of ACS and has been shown to be associated with adverse outcomes • However, troponin is not typically evaluated in patients with stable CAD • To date the incidence and prognostic significance of troponin elevation among patients with stable CAD undergoing PCI is unknown

  4. Objective • To determine the prevalence of baseline troponin elevation in patients undergoing PCI for stable angina or abnormal cardiac stress test • To examine the association between elevated troponin and peri-procedural ischemic complications • To evaluate the long-term outcome among patients with baseline troponin elevation

  5. Study Design • The EVENT registry is a U.S. wide collaborative effort to assess “real clinical practice” by performing a prospective evaluation of unselected patients undergoing stent implantation • Baseline characteristics, angiographic outcomes, post-procedural elevation of biomarkers of myocardial necrosis and clinical end points are collected prospectively by case report forms (CRF) • Patients are evaluated during their index hospital admission, and 1-year after receiving the stents • The population for this analysis consists of 7592 patients from 47 centers in the U.S. recruited in a total of three waves

  6. 7592 Patients 613 Excluded (STEMI) Study Population N = 6979 3110 Excluded (ACS) N=3869 133 Excluded (Baseline CKMB >=1xULN) N=3736Clinically Eligible 1129 Excluded (Baseline CKMB not drawn ) N=2607 225 Excluded (Baseline cTn not available) N=2382Analytic Cohort

  7. Methods – Medical Therapy • All patients undergoing PCI were premedicated with 325 mg aspirin, and continued indefinitely • Antithrombotic regimens (heparin, bivalirudin, glycoprotein IIb/IIIa inhibitors) were at the discretion of the treating physicians • A loading dose of clopidogrel (300-600 mg) was given prior to the procedure or in the catheterization laboratory (unless patients were already on clopidogrel therapy), and clopidogrel 75 mg daily was recommended for 3-12 months

  8. Methods – Study Endpoints • Baseline clinical and procedural data were collected prospectively • In-hospital outcomes in patients according to baseline troponin status (elevated vs. normal) were evaluated according to site-specific reference levels • All events were adjudicated by 2 observers independently • Study endpoints included a composite of death and MI at hospital discharge and at 1 year

  9. Methods – Statistical Analysis A stepwise, sequentially saturated multivariate model was used with adjustments for the following variables: • Demographic: Age, gender • Clinical: DM, prior MI, prior CABG, estimated GFR • Angiographic: No. of diseased vessels, no. of lesions treated, bifurcation lesion, type B2 or C lesion, thrombus • Treatment variables: Pre-procedure thienopyridine use

  10. Results - Prevalence of Baseline cTn elevation in Stable CAD Degree of cTn Elevation 1-3x ULN 69.7% 3-5x ULN 8.5% 5-10x ULN 14.1% >10x ULN 7.7%

  11. Baseline Clinical Characteristics Troponin + Troponin - p n=142 n=2240 Age, years 65.5±10.8 64.5±10.7 NS Arterial Hypertension 84.4% 78.7% NS Diabetes Mellitus 37.3% 34.6% NS Hyperlipidemia 81.6% 79.0% NS Current Smoking 20.7% 20.5% NS eGFR, ml/min/1.73m2 81.6±36.7 89.5±44.1 0.017 LV EF<35% 6.3% 7.2% NS Previous MI 20.6% 23.7% NS Previous CABG 23.2% 23.4% NS

  12. Baseline Angiographic Characteristics Troponin + Troponin - p n=212 Lesions n=3063 Lesions Lesions treated, n 1.5±0.8 1.4±0.6 NS Type B2/C lesions 58.4% 50.4% 0.01 Angiographic Thrombus 6.1% 5.8% NS Pre-procedure TIMI 3 flow 83.0% 83.9% NS Bifurcation Lesion 15.1% 10.4% 0.03 DES implanted 93.0% 92.9% NS Total stent length, mm 23.6±13.4 22.2±12.3 NS Min. stent diameter, mm 3.0±0.8 3.0±0.9 NS Glycoprotein IIb/IIIa Inhibitor 34.3% 25.3% NS Bivalirudin 27.1% 49.8% <0.001 Clopidogrel Pre-Treatment 43.7% 58.6% 0.002

  13. Results– Death/MI % % P<0.001 P=0.06

  14. Results– Repeat PCI/CABG % % P=0.06 P=NS

  15. Results – In Hospital Clinical Outcomes Troponin + Troponin - p n=142 n=2240 Death or MI 13.4% 5.6% <0.001 Death 0.7% 0.0% 0.06 MI 13.4% 5.6% <0.001 Urgent Repeat PCI 1.4% 0.2% 0.06 Urgent CABG 0.7% 0.3% NS Stent Thrombosis 0.0% 0.2% NS

  16. Risk-Adjusted Risk of in-Hospital Death or MI Odds Ratio Univariate analysis Adjusted for demographic Factors Adjusted for demographic and clinical Factors Adjusted for demographic, clinical and angiographic Factors Adjusted for demographic, clinical, angiographic, and treatment factors 0 2 4 6

  17. One-Year Clinical Outcomes Troponin + Troponin - Adjusted HR p Death or MI 16.8% 7.3% 2.03 (1.2-3.3) 0.005 Death 2.4% 0.4% 4.78 (1.2-19.4) 0.03 MI 15.5% 7.0% 2.00 (1.2-3.3) 0.007

  18. Limitations • Registry data not as reliable as prospective, randomized trials • Cannot rule out selection bias as PCI strategy and overall medical care was left to the discretion of the operator

  19. Conclusion • The prevalence of elevated troponin levels in elective patients (stable angina or positive stress test) undergoing PCI is surprisingly high • Baseline troponin elevation is associated with a 2-fold increased risk of death or MI in-hospital and at 1-year follow up • If these findings are confirmed in future studies, consideration should be given to routine testing of troponin in this population before PCI • If more aggressive pharmacologic or PCI strategies are warranted in this high-risk group to decrease adverse events is currently unknown

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