Table 3.
Diagnostic performance, efficacy, and safety of a single baseline hs-cTnT below the limit of quantitation of 6 ng/L for index acute MI rule-out in patients in the adjudicated cohort. LoQ: limit of quantitation.
| Total Cohort | Total cohort with nonischemic ECG | |||||
|---|---|---|---|---|---|---|
| Total | Men | Women | Total | Men | Women | |
| Population and incidence of MI | ||||||
| Total patients, n | 1979 | 949 | 1030 | 1849 | 895 | 954 |
| Incidence of MI, n (%) | 141 (7.1) | 70 (7.4) | 71 (6.9) | 95 (5.0) | 51 (5.7) | 44 (4.6) |
| Efficacy: number (percentage) of patients identified as low risk | ||||||
| Patients with baseline hs-cTnT <LoQ (efficacy), n (%) | 624 (32) |
214 (23) |
410 (40) |
610 (33) |
210 (23) |
400 (42) |
| Diagnostic performance of baseline hs-cTnT<LoQ for ruling-out index presentation acute MI | ||||||
| Negative predictive value, % (95% CI) |
99.8 (99.1, 100) |
100 (98.3, 100) |
99.8 (98.7, 100) |
100 (99.4, 100) |
100 (98.3, 100) |
100 (99.1, 100) |
| Sensitivity, % (95% CI) |
99.3 (96.1, 100) |
100 (94.9, 100) |
98.6 (92.4, 100) |
100 (96.2, 100) |
100 (93.0, 100) |
100 (92.0, 100) |
| Negative likelihood ratio, (95% CI) |
0.02 (0.00–0.15) |
0 | 0.03 (0.00–0.23) |
0 | 0 | 0 |
| Missed MI rate among those with a negative test | 0.2% 1/624 |
0% 0/214 |
0.2% 1/410 |
0% 0/610 |
0% 0/210 |
0% 0/400 |
| Safety of baseline hs-cTnT<LoQ based on acute MI or death within 30-days | ||||||
| Negative predictive value, % (95% CI) |
99.7 (98.9, 100) |
100 (98.3, 100) |
99.5 (98.3, 99.9) |
99.8 (99.1, 100) |
100 (98.3, 100) |
99.8 (98.6, 100) |
| Sensitivity, % (95% CI) |
99.0 (96.4, 99.9) |
100 (96.3, 100) |
98.0 (92.8, 99.8) |
99.3 (96.2, 100) |
100 (95.2, 100) |
98.6 (92.3, 100) |
| Negative likelihood ratio, (95% CI) |
0.03 (0.01–0.12) |
0 | 0.05 (0.01–0.18) |
0.02 (0.00–0.14) |
0 | 0.03 (0.00–0.22) |
| Missed acute MI or death within 30-days among those with a negative test | 0.3% 2/624 |
0% 0/214 |
0.5% 2/410 |
0.2% 1/610 |
0% 0/210 |
0.3% 1/400 |