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Eur Heart J Acute Cardiovasc Care. 2017 Sep;6(6):500-510. doi: 10.1177/2048872616641901. Epub 2016 Apr 4.

Outcomes after planned invasive or conservative treatment strategy in patients with non-ST-elevation acute coronary syndrome and a normal value of high sensitivity troponin at randomisation: A Platelet Inhibition and Patient Outcomes (PLATO) trial biomarker substudy.

Author information

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.

KEYWORDS:

Acute coronary syndrome; biological markers; blood platelets; myocardial infarction

PMID:
27044282
DOI:
10.1177/2048872616641901
[Indexed for MEDLINE]

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