Direct Comparison of 2 Rule-Out Strategies for Acute Myocardial Infarction

TY - JOUR

T1 - Direct Comparison of 2 Rule-Out Strategies for Acute Myocardial Infarction

T2 - 2-h Accelerated Diagnostic Protocol vs 2-h Algorithm

AU - Wildi, Karin

AU - Cullen, Louise

AU - Twerenbold, Raphael

AU - Greenslade, Jaimi H

AU - Parsonage, William

AU - Boeddinghaus, Jasper

AU - Nestelberger, Thomas

AU - Sabti, Zaid

AU - Rubini-Giménez, Maria

AU - Puelacher, Christian

AU - Cupa, Janosch

AU - Schumacher, Lukas

AU - Badertscher, Patrick

AU - Grimm, Karin

AU - Kozhuharov, Nikola

AU - Stelzig, Claudia

AU - Freese, Michael

AU - Rentsch, Katharina

AU - Lohrmann, Jens

AU - Kloos, Wanda

AU - Buser, Andreas

AU - Reichlin, Tobias

AU - Pickering, John W

AU - Than, Martin

AU - Mueller, Christian

N1 - © 2017 American Association for Clinical Chemistry.

PY - 2017/7

Y1 - 2017/7

N2 - BACKGROUND: We compared 2 high-sensitivity cardiac troponin (hs-cTn)-based 2-h strategies in patients presenting with suspected acute myocardial infarction (AMI) to the emergency department (ED): the 2-h accelerated diagnostic protocol (2h-ADP) combining hs-cTn, electrocardiogram, and a risk score, and the 2-h algorithm exclusively based on hs-cTn concentrations and their absolute changes.METHODS: Analyses were performed in 2 independent diagnostic cohorts [European Advantageous Predictors of Acute Coronary Syndrome Evaluation (APACE) study, Australian-New Zealand 2-h Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker (ADAPT) study] employing hs-cTnT (Elecsys) and hs-cTnI (Architect). The final diagnosis was adjudicated by 2 independent cardiologists.RESULTS: AMI was the final diagnosis in 16.5% (95% CI, 14.6%-18.6%) of the 1372 patients in APACE, and 12.6% (95% CI, 10.7%-14.7%) of 1153 patients in ADAPT. The negative predictive value (NPV) and sensitivity for AMI were very high and comparable with both strategies using either hs-cTnT or hs-cTnI in both cohorts (all statistical comparisons nonsignificant). The percentage of patients triaged toward rule-out was significantly lower with the 2h-ADP (36%-43%) vs the 2-h algorithm (55%-68%) with both assays and in both cohorts (P < 0.001). The sensitivity of the 2h-ADP was higher for 30-day major adverse cardiovascular events.CONCLUSIONS: Both algorithms provided very high and comparable safety as quantified by the NPV and sensitivity for AMI and major adverse cardiac events (MACE) at 30 days in patients triaged toward rule-out, although sensitivity for MACE at 30 days was lower with both algorithms in cohort 2. Although the 2-h algorithm was more efficacious, not all patients ruled out for AMI by this algorithm were appropriate candidates for early discharge. The 2h-ADP seems superior in the selection of patients for early discharge from the ED.CLINICAL TRIAL REGISTRATION: APACE: http://clinicaltrials.gov/show/NCT00470587ADAPT: Australia-New Zealand Clinical Trials Registry ACTRN12611001069943.

AB - BACKGROUND: We compared 2 high-sensitivity cardiac troponin (hs-cTn)-based 2-h strategies in patients presenting with suspected acute myocardial infarction (AMI) to the emergency department (ED): the 2-h accelerated diagnostic protocol (2h-ADP) combining hs-cTn, electrocardiogram, and a risk score, and the 2-h algorithm exclusively based on hs-cTn concentrations and their absolute changes.METHODS: Analyses were performed in 2 independent diagnostic cohorts [European Advantageous Predictors of Acute Coronary Syndrome Evaluation (APACE) study, Australian-New Zealand 2-h Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker (ADAPT) study] employing hs-cTnT (Elecsys) and hs-cTnI (Architect). The final diagnosis was adjudicated by 2 independent cardiologists.RESULTS: AMI was the final diagnosis in 16.5% (95% CI, 14.6%-18.6%) of the 1372 patients in APACE, and 12.6% (95% CI, 10.7%-14.7%) of 1153 patients in ADAPT. The negative predictive value (NPV) and sensitivity for AMI were very high and comparable with both strategies using either hs-cTnT or hs-cTnI in both cohorts (all statistical comparisons nonsignificant). The percentage of patients triaged toward rule-out was significantly lower with the 2h-ADP (36%-43%) vs the 2-h algorithm (55%-68%) with both assays and in both cohorts (P < 0.001). The sensitivity of the 2h-ADP was higher for 30-day major adverse cardiovascular events.CONCLUSIONS: Both algorithms provided very high and comparable safety as quantified by the NPV and sensitivity for AMI and major adverse cardiac events (MACE) at 30 days in patients triaged toward rule-out, although sensitivity for MACE at 30 days was lower with both algorithms in cohort 2. Although the 2-h algorithm was more efficacious, not all patients ruled out for AMI by this algorithm were appropriate candidates for early discharge. The 2h-ADP seems superior in the selection of patients for early discharge from the ED.CLINICAL TRIAL REGISTRATION: APACE: http://clinicaltrials.gov/show/NCT00470587ADAPT: Australia-New Zealand Clinical Trials Registry ACTRN12611001069943.

KW - Aged

KW - Algorithms

KW - Diagnostic Techniques, Cardiovascular/standards

KW - Female

KW - Humans

KW - Male

KW - Myocardial Infarction/blood

KW - Prospective Studies

KW - Troponin I/blood

KW - Troponin T/blood

U2 - 10.1373/clinchem.2016.268359

DO - 10.1373/clinchem.2016.268359

M3 - SCORING: Journal article

C2 - 28515106

VL - 63

SP - 1227

EP - 1236

JO - CLIN CHEM

JF - CLIN CHEM

SN - 0009-9147

IS - 7

ER -