Twerenbold, RaphaelRaphaelTwerenboldBadertscher, PatrickPatrickBadertscherBoeddinghaus, JasperJasperBoeddinghausNestelberger, ThomasThomasNestelbergerWildi, KarinKarinWildiPuelacher, ChristianChristianPuelacherSabti, ZaidZaidSabtiRubini Gimenez, MariaMariaRubini GimenezTschirky, SandraSandraTschirkydu Fay de Lavallaz, JeanneJeannedu Fay de LavallazKozhuharov, NikolaNikolaKozhuharovSazgary, LorraineLorraineSazgaryMueller, DeborahDeborahMuellerBreidthardt, TobiasTobiasBreidthardtStrebel, IvoIvoStrebelFlores Widmer, DayanaDayanaFlores WidmerShrestha, SamyutSamyutShresthaMiró, ÒscarÒscarMiróMartín-Sánchez, F JavierF JavierMartín-SánchezMorawiec, BeataBeataMorawiecParenica, JiriJiriParenicaGeigy, NicolasNicolasGeigyKeller, Dagmar IDagmar IKellerRentsch, KatharinaKatharinaRentschvon Eckardstein, ArnoldArnoldvon EckardsteinOsswald, StefanStefanOsswaldReichlin, Tobias RomanTobias RomanReichlin0000-0002-7197-8415Mueller, ChristianChristianMueller2024-10-082024-10-082018-01-30https://boris-portal.unibe.ch/handle/20.500.12422/64139BACKGROUND The European Society of Cardiology recommends a 0/1-hour algorithm for rapid rule-out and rule-in of non-ST-segment elevation myocardial infarction using high-sensitivity cardiac troponin (hs-cTn) concentrations irrespective of renal function. Because patients with renal dysfunction (RD) frequently present with increased hs-cTn concentrations even in the absence of non-ST-segment elevation myocardial infarction, concern has been raised regarding the performance of the 0/1-hour algorithm in RD. METHODS In a prospective multicenter diagnostic study enrolling unselected patients presenting with suspected non-ST-segment elevation myocardial infarction to the emergency department, we assessed the diagnostic performance of the European Society of Cardiology 0/1-hour algorithm using hs-cTnT and hs-cTnI in patients with RD, defined as an estimated glomerular filtration rate <60 mL/min/1.73 m, and compared it to patients with normal renal function. The final diagnosis was centrally adjudicated by 2 independent cardiologists using all available information, including cardiac imaging. Safety was quantified as sensitivity in the rule-out zone, accuracy as the specificity in the rule-in zone, and efficacy as the proportion of the overall cohort assigned to either rule-out or rule-in based on the 0- and 1-hour sample. RESULTS Among 3254 patients, RD was present in 487 patients (15%). The prevalence of non-ST-segment elevation myocardial infarction was substantially higher in patients with RD compared with patients with normal renal function (31% versus 13%, <0.001). Using hs-cTnT, patients with RD had comparable sensitivity of rule-out (100.0% [95% confidence interval {CI}, 97.6-100.0] versus 99.2% [95% CI, 97.6-99.8]; =0.559), lower specificity of rule-in (88.7% [95% CI, 84.8-91.9] versus 96.5% [95% CI, 95.7-97.2]; <0.001), and lower overall efficacy (51% versus 81%, <0.001), mainly driven by a much lower percentage of patients eligible for rule-out (18% versus 68%, <0.001) compared with patients with normal renal function. Using hs-cTnI, patients with RD had comparable sensitivity of rule-out (98.6% [95% CI, 95.0-99.8] versus 98.5% [95% CI, 96.5-99.5]; =1.0), lower specificity of rule-in (84.4% [95% CI, 79.9-88.3] versus 91.7% [95% CI, 90.5-92.9]; <0.001), and lower overall efficacy (54% versus 76%, <0.001; proportion ruled out, 18% versus 58%, <0.001) compared with patients with normal renal function. CONCLUSIONS In patients with RD, the safety of the European Society of Cardiology 0/1-hour algorithm is high, but specificity of rule-in and overall efficacy are decreased. Modifications of the rule-in and rule-out thresholds did not improve the safety or overall efficacy of the 0/1-hour algorithm. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00470587.en0/1-hour algorithm chronic kidney disease diagnosis of acute myocardial infarction high-sensitivity cardiac troponin renal dysfunction600 - Technology::610 - Medicine & healtharticle10.7892/boris.1263552910128710.1161/CIRCULATIONAHA.117.028901