Author/Authors :
Cullen، نويسنده , , Louise and Mueller، نويسنده , , Christian and Parsonage، نويسنده , , William A. and Wildi، نويسنده , , Karin and Greenslade، نويسنده , , Jaimi H. and Twerenbold، نويسنده , , Raphael and Aldous، نويسنده , , Sally and Meller، نويسنده , , Bernadette and Tate، نويسنده , , Jillian R. and Reichlin، نويسنده , , Tobias and Hammett، نويسنده , , Christopher J. and Zellweger، نويسنده , , Christa and Ungerer، نويسنده , , Jacobus P.J. and Rubini Gimenez، نويسنده , , Maria and Troughton، نويسنده , , Richard M. Murray، نويسنده , , Karsten and Brown، نويسنده , , Anthony F.T. and Mueller، نويسنده , , Mira and George، نويسنده , , Peter and Mosimann، نويسنده , , Tamina and Flaws، نويسنده , , Dylan F. and Reiter، نويسنده , , Miriam and Lamanna، نويسنده , , Arvin and Haaf، نويسنده , , Philip W. Pemberton، نويسنده , , Christopher J. and Richards، نويسنده , , A. Mark and Chu، نويسنده , , Kevin and Reid، نويسنده , , Christopher M. and Peacock، نويسنده , , William Frank and Jaffe، نويسنده , , Allan S. and Florkowski، نويسنده , , Christopher and Deely، نويسنده , , Joanne M. and Than، نويسنده , , Martin، نويسنده ,
Abstract :
Objectives
udy objective was to validate a new high-sensitivity troponin I (hs-TnI) assay in a clinical protocol for assessing patients who present to the emergency department with chest pain.
ound
ols using sensitive troponin assays can accelerate the rule out of acute myocardial infarction in patients with low-risk (suspected) acute coronary syndrome (ACS).
s
tudy evaluated 2 prospective cohorts of patients in the emergency department with ACS in an accelerated diagnostic pathway integrating 0- and 2-h hs-TnI results, Thrombolysis In Myocardial Infarction (TIMI) risk scores, and electrocardiography. Strategies to identify low-risk patients incorporated TIMI risk scores = 0 or ≤1. The primary endpoint was a major adverse cardiac event (MACE) within 30 days.
s
primary cohort, 1,635 patients were recruited and had 30-day follow-up. A total of 247 patients (15.1%) had a MACE. The finding of no ischemic electrocardiogram and hs-TnI ≤26.2 ng/l with the TIMI = 0 and TIMI ≤1 pathways, respectively, classified 19.6% (n = 320) and 41.5% (n = 678) of these patients as low risk; 0% (n = 0) and 0.8% (n = 2) had a MACE, respectively. In the secondary cohort, 909 patients were recruited. A total of 156 patients (17.2%) had a MACE. The TIMI = 0 and TIMI ≤1 pathways classified 25.3% (n = 230) and 38.6% (n = 351), respectively, of these patients as low risk; 0% (n = 0) and 0.8% (n = 1) had a MACE, respectively. Sensitivity, specificity, and negative predictive value for TIMI = 0 in the primary cohort were 100% (95% confidence interval [CI]: 98.5% to 100%), 23.1% (95% CI: 20.9% to 25.3%), and 100% (95% CI: 98.8% to 100%), respectively. Sensitivity, specificity, and negative predictive value for TIMI ≤1 in the primary cohort were 99.2 (95% CI: 97.1 to 99.8), 48.7 (95% CI: 46.1 to 51.3), and 99.7 (95% CI: 98.9 to 99.9), respectively. Sensitivity, specificity, and negative value for TIMI ≤1 in the secondary cohort were 99.4% (95% CI: 96.5 to 100), 46.5% (95% CI: 42.9 to 50.1), and 99.7% (95% CI: 98.4 to 100), respectively.
sions
ly-discharge strategy using an hs-TnI assay and TIMI score ≤1 had similar safety as previously reported, with the potential to decrease the observation periods and admissions for approximately 40% of patients with suspected ACS. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE] Study, NCT00470587; A 2hr Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker [ADAPT]: a prospective observational validation study, ACTRN12611001069943)
