Favourable in-hospital outcome is observed in numerous patients after Non ST myocardial infarction (NSTEMI) with invasive strategy but European guidelines proposed systematic intensive care unit monitoring up to 24 h in lower risk patients (grade 1, level of evidence C). Regarding absence of prospective study supporting this strategy, we assessed the hypothesis that the lower risk NSTEMI patients identified through simple medical criteria and after coronary angiography evaluation may not require intensive care unit admission.
The incidence of serious in hospital complications after NSTEMI has dramatically decreased over the past decades mainly due to early coronary angioplasty with new generation drug eluting stents surrounded by an optimal antithrombotic treatment (1). Major in-hospital adverse events after NSTEMI became uncommon and above all appears predictable including unstable hemodynamic state, acute stent thrombosis and life threatening arrhythmia (5-7). Recent 2020 European guidelines recommended that all patients with NSTEMI should be monitored up to 24 hours or up to percutaneous coronary intervention (PCI) in the intensive care unit (ICU) and rhythm monitoring \> 24 h in patients at intermediate or high risk of cardiac arrhythmia (2). However, the usefulness of systematic ICU admission and ECG monitoring, for lower risk patients particularly when they have been stabilized with successful (PCI) has never been evaluated in a randomized study and remain controversial (8-10). The main objective of this randomized study is to validate the feasibility and safety of a strategy without intensive care unit admission of lower risk NSTEMI patients after coronary angiography evaluation and successful PCI when required, compared to the conventional strategy using systematic ICU monitoring. All patients admitted in our hospital for NSTEMI (initial admission of patients in ICU or directly in the cath lab) will have systematic coronary angiography evaluation and PCI when required. They will be classified as low or high risk patients related to guidelines derived criteria including results of coronary angiography evaluation. Low risk patients will be randomized in ICU admission group (control group) or general cardiology ward (GCW) group (experimental group) without ECG monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Patient hospitalized in Intensive care unit with ECG monitoring
Patient hospitalized in General cardiology ward without ECG monitoring. patients randomized in this group will not be hospitalized in intensive care unit unless an event require intensive care unit monitoring.
UH Nîmes
Nîmes, Gard, France
RECRUITINGUH Montpellier
Montpellier, France
RECRUITINGUH Toulouse
Toulouse, France
WITHDRAWNSuccess of the experimental strategy defined by absence of major adverse events 4 +/- 3 days after inclusion
Major adverse events include : mortality (total and cardiovascular), severe bleeding (BARC criteria \>2), major vascular events (BARC 3 or 4 criteria) , cardiac failure requiring specific therapy ,acute kidney injury (RAKIN classification ≥grade 2) , major neurologic events confirmed with brain imaging, severe conductive or rhythm disorder, new coronary ischemic event requiring coronary angiography, any medical decision for secondary ICU transfer
Time frame: 4 +/- 3 days after inclusion
Incidence of low vs high risk NSTEMI patients admitted in ICU or in cath lab
number of low vs high risk NSTEMI (flow chart)
Time frame: 1 month follow up
Incidence of each event included in the combined primary outcome
evaluation of each event of combined primary end point
Time frame: 1 month follow up
Comparison of hospitalization length of stay for the 2 groups
lenght of stay in ICU and total hospitalization stay in days
Time frame: though hospital follow up, an average of 5 days
ICU length of stay in the control group
ICU length of stay in the control group in days
Time frame: though hospital follow up, an average of 5 days
Evolution of patient satisfaction (questionnaire)
a short 5 questions by phone regarding satisfaction in the 2 groups
Time frame: 1 month +/- 7 days after inclusion
Comparison of total mortality in both arm
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SUPPORTIVE_CARE
Masking
NONE
Enrollment
320
total mortality in both arms
Time frame: 1 month +/- 7 days after inclusion
Comparison of cardiovascular mortality in both arm
cardiovascular mortality in both arms
Time frame: 1 month +/- 7 days after inclusion
Comparison of new hospitalization for cardiac event in both arms
new hospitalization for cardiac reasons
Time frame: 1 month +/- 7 days after inclusion
Comparison of direct medical cost of the initial inpatient stay in both arm
economic study regarding medical cost
Time frame: during hospitalization stay