An immediate or early invasive strategy in non-ST-elevation acute coronary syndrome: The OPTIMA-2 randomized controlled trial - 09/03/21
, Giovanni Amoroso, MD,PhD a, Maarten A. Vink, MD,PhD a, Ton Slagboom, MD a, René J. van der Schaaf, MD,PhD a, Jean-Paul Herrman, MD,PhD a, Mark S. Patterson, MD,PhD a, Erik F.J. Oosterwerff, MD b, Nicola S. Vos, MD,PhD a, Freek W.A. Verheugt, MD,PhD a, Jan G.P. Tijssen, PhD c, Robbert J. de Winter, MD,PhD c, Robert K. Riezebos, MD,PhD aRésumé |
Background |
In intermediate- and high-risk non-ST elevated acute coronary syndrome (NSTE-ACS) patients, a routine invasive approach is recommended. The timing of coronary angiography remains controversial. To assess whether an immediate (<3 hours) invasive treatment strategy would reduce infarct size and is safe, compared with an early strategy (12-24 hours), for patients admitted with NSTE-ACS while preferably treated with ticagrelor.
Methods |
In this single-center, prospective, randomized trial an immediate or early invasive strategy was randomly assigned to patients with NSTE-ACS. At admission, the patients were preferably treated with a combination of aspirin, ticagrelor and fondaparinux. The primary endpoint was the infarct size as measured by area under the curve (AUC) of CK-MB in 48 hours. Secondary endpoints were bleeding outcomes and major adverse cardiac events (MACE): composite of all-cause death, MI and unplanned revascularization. Interim analysis showed futility regarding the primary endpoint and trial inclusion was terminated.
Results |
In total 249 patients (71% of planned) were included. The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group (IQR 112-618) and 201.3 ng/mL in the early group (IQR 119-479). Clinical follow-up was 1-year. The MACE-rate was 10% in the immediate and 10% in the early group (hazard ratio [HR] 1.13, 95% CI: 0.52-2.49).
Conclusions |
In NSTE-ACS patients randomized to either an immediate or an early-invasive strategy the observed median difference in the primary endpoint was about half the magnitude of the expected difference. The trial was terminated early for futility after 71% of the projected enrollment had been randomized into the trial.
Le texte complet de cet article est disponible en PDF.Abbreviations : AUC, BARC, CABG, CI, CK-MB, MACE, NACE, NSTE-ACS, STEMI
Plan
Vol 234
P. 42-50 - avril 2021 Retour au numéro
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