title: Early or late intervention in high-risk non-ST-elevation acute coronary syndromes: results of the ELISA-3 trial.
abstract: OBJECTIVE
  To compare an early to a delayed invasive strategy in high-risk patients with NSTE-ACS.
  
  
  RESULTS
  In this prospective multicentre trial, 542 patients hospitalised with NSTE-ACS were randomised to either an immediate (angiography and revascularisation if appropriate <12 hr) or a delayed invasive strategy (>48 hr after randomisation). Patients were eligible if they had two of the following three high-risk characteristics: evidence of extensive myocardial ischaemia on ECG, elevated biomarkers for myocardial necrosis (TropT >0.10 μg/L), and an age above 65 years. Primary endpoint of the study was the combined incidence of death, reinfarction and/or recurrent ischaemia at 30-day follow-up. Secondary endpoints were enzymatic infarct size as assessed by a single cardiac troponin T, at 72-96 hours after admission or at discharge, and the percentage of patients without a rise in CKMB during admission. Median age was 71.9 (interquartile range [IQR] 64.5-78.4) years. Median time between randomisation and start of angiography was 2.6 (IQR 1.2-6.2) hours in the immediate and 54.9 (44.2-74.5) hours in the delayed intervention group. The composite of death, reinfarction and/or recurrent ischaemia at 30 days occurred in 12% of patients and was not significantly different between the two groups (9.9% and 14.2%, respectively, p=0.135). All secondary endpoints and bleeding complications were comparable. Hospital duration was two days shorter in the immediate intervention group (4 days [IQR 2-10] vs. 6 days [IQR 4-12]).
  
  
  CONCLUSIONS
  Although no definitive conclusion can be drawn due to a lower than expected prevalence of the primary endpoint, an immediate invasive strategy was safe and feasible but not superior to a delayed invasive strategy in terms of the combined primary endpoint of death, reinfarction and/or recurrent ischaemia at 30 days. These results are consistent with previous randomised trials which studied the effect of timing of angiography in patients with NSTE-ACS.
  
  
  BACKGROUND
  ISRCTN Register 9230163.
authors.affiliation: Deventer Ziekenhuis, Deventer, The Netherlands.
authors.forename: Erik A
authors.initials: EA
authors.lastname: Badings
authors.forename: Salem H K
authors.initials: SH
authors.lastname: The
authors.forename: Jan-Henk E
authors.initials: JH
authors.lastname: Dambrink
authors.forename: Jan
authors.initials: J
authors.lastname: van Wijngaarden
authors.forename: Geert
authors.initials: G
authors.lastname: Tjeerdsma
authors.forename: Saman
authors.initials: S
authors.lastname: Rasoul
authors.forename: Jorik R
authors.initials: JR
authors.lastname: Timmer
authors.forename: Marloes L J
authors.initials: ML
authors.lastname: van der Wielen
authors.forename: Dirk J A
authors.initials: DJ
authors.lastname: Lok
authors.forename: Arnoud W J
authors.initials: AW
authors.lastname: van 't Hof
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000367:Age Factors; D000368:Aged; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D052279:Creatine Kinase, MB Form / Q000097:blood; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D009426:Netherlands; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D013997:Time Factors; D061665:Time-to-Treatment; D016896:Treatment Outcome; D020107:Troponin T / Q000097:blood
chemical_list: D015415:Biomarkers; D020107:Troponin T; D052279:Creatine Kinase, MB Form