Evangelos Giannitsis1, Lars Wallentin2,3, Stefan K James2,3, Maria Bertilsson3, Agneta Siegbahn2,3, Robert F Storey4, Steen Husted5, Christopher P Cannon6,7, Paul W Armstrong8, Philippe G Steg9,10,11,12,13, Hugo A Katus1. 1. 1 Medizinische Klinik, Universitätsklinikum Heidelberg, Germany. 2. 2 Department of Medical Sciences, Uppsala University, Sweden. 3. 3 Uppsala Clinical Research Center, Uppsala University, Sweden. 4. 4 Department of Cardiovascular Science, University of Sheffield, UK. 5. 5 Medical Department, Hospital Unit West, Herning/Holstebro, Denmark. 6. 6 Cardiovascular Division, Brigham and Women's Hospital, USA. 7. 7 Harvard Clinical Research Institute, USA. 8. 8 Canadian VIGOUR Centre, University of Alberta, Canada. 9. 9 INSERM-Unité 1148, France. 10. 10 Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France. 11. 11 Université Paris-Diderot, Sorbonne-Paris Cité, France. 12. 12 National Heart and Lung Institute, Imperial College London, UK. 13. 13 Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, UK.
Abstract
AIMS: Current guidelines for patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) recommend early invasive treatment in intermediate-to-high risk patients based on medical history, electrocardiogram (ECG) and elevated troponin. Patients with normal levels of cardiac troponin measured with a high-sensitivity method (cTnT-hs) might not benefit from early invasive procedures. METHODS AND RESULTS: In this Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) blood-core substudy, 1232 patients presented with NSTE-ACS had a high sensitivity cardiac troponin T (cTnT-hs) level <99th percentile (<14 ng/l) at randomisation. The outcomes in relation to a planned invasive ( n=473) vs planned conservative treatment ( n=759), were evaluated by adjusted Cox proportional hazard analyses. In patients with a normal cTnT-hs at randomisation, regardless of randomised treatment, a planned invasive vs conservative treatment was associated with a 2.3-fold higher risk (7.3% vs 3.4%, p=0.0028) for cardiovascular (CV) death or myocardial infarction (MI), driven by higher rates of procedure-related MI (3.4% vs 0.1%), while there were no differences in rates of CV death (1.3% vs 1.3%, p=0.72) or spontaneous MI (3.0% vs 2.1%, p=0.28). There were significantly more major bleeds (hazard ratio (HR) 2.98, p<0.0001), mainly due to coronary artery bypass graft (CABG)-related (HR 4.05, p<0.0001) and non-CABG procedural-related major bleeding events (HR 5.31, p=0.0175), however there were no differences in non-procedure-related major bleeding (1.5% vs 1.9%, p=0.45). Findings were consistent for patients with a normal cTnI-hs at randomisation. CONCLUSIONS: In patients with NSTE-ACS and normal cTnT-hs, a planned early invasive treatment strategy was associated with increased rates of procedure-related MI and bleeding but no differences in long-term spontaneous MI, non-procedure-related bleeding or mortality.
RCT Entities:
AIMS: Current guidelines for patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) recommend early invasive treatment in intermediate-to-high risk patients based on medical history, electrocardiogram (ECG) and elevated troponin. Patients with normal levels of cardiac troponin measured with a high-sensitivity method (cTnT-hs) might not benefit from early invasive procedures. METHODS AND RESULTS: In this Prospective Randomized Platelet Inhibition and Patient Outcomes (PLATO) blood-core substudy, 1232 patients presented with NSTE-ACS had a high sensitivity cardiac troponin T (cTnT-hs) level <99th percentile (<14 ng/l) at randomisation. The outcomes in relation to a planned invasive ( n=473) vs planned conservative treatment ( n=759), were evaluated by adjusted Cox proportional hazard analyses. In patients with a normal cTnT-hs at randomisation, regardless of randomised treatment, a planned invasive vs conservative treatment was associated with a 2.3-fold higher risk (7.3% vs 3.4%, p=0.0028) for cardiovascular (CV) death or myocardial infarction (MI), driven by higher rates of procedure-related MI (3.4% vs 0.1%), while there were no differences in rates of CV death (1.3% vs 1.3%, p=0.72) or spontaneous MI (3.0% vs 2.1%, p=0.28). There were significantly more major bleeds (hazard ratio (HR) 2.98, p<0.0001), mainly due to coronary artery bypass graft (CABG)-related (HR 4.05, p<0.0001) and non-CABG procedural-related major bleeding events (HR 5.31, p=0.0175), however there were no differences in non-procedure-related major bleeding (1.5% vs 1.9%, p=0.45). Findings were consistent for patients with a normal cTnI-hs at randomisation. CONCLUSIONS: In patients with NSTE-ACS and normal cTnT-hs, a planned early invasive treatment strategy was associated with increased rates of procedure-related MI and bleeding but no differences in long-term spontaneous MI, non-procedure-related bleeding or mortality.
Authors: Patrizia Natale; Suetonia C Palmer; Valeria M Saglimbene; Marinella Ruospo; Mona Razavian; Jonathan C Craig; Meg J Jardine; Angela C Webster; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2022-02-28
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Authors: Evangelos Giannitsis; Piers Clifford; Anna Slagman; Ralph Ruedelstein; Christoph Liebetrau; Christian Hamm; Didier Honnart; Kurt Huber; Jörn Ole Vollert; Carlo Simonelli; Malte Schröder; Jan C Wiemer; Matthias Mueller-Hennessen; Hinrich Schroer; Kim Kastner; Martin Möckel Journal: BMJ Open Date: 2019-07-23 Impact factor: 2.692
Authors: Evangelos Giannitsis; Moritz Biener; Hauke Hund; Matthias Mueller-Hennessen; Mehrshad Vafaie; Jochen Gandowitz; Christoph Riedle; Julia Löhr; Hugo A Katus; Kiril M Stoyanov Journal: Clin Res Cardiol Date: 2019-07-19 Impact factor: 5.460