Optimal Timing of Intervention in NSTE-ACS Without Pretreatment With P2Y12-ADP Receptor Antagonists - EARLY
Contribution To Literature:
The EARLY trial showed that a very early invasive strategy is superior to a delayed invasive strategy in improving symptoms of recurrent ischemia among patients presenting with intermediate- to high-risk NSTE-ACS and not pretreated with P2Y2 inhibitors, with no difference in clinical endpoints.
The goal of the trial was to assess the safety and efficacy of a very early invasive strategy compared with a delayed invasive strategy among patients with intermediate- to high-risk non−ST-segment elevation acute coronary syndrome (NSTE-ACS) who were not pretreated with a P2Y2 inhibitors.
Eligible patients were randomized in a 1:1 fashion to very early invasive approach (within 2 hours) (n = 346) or delayed invasive strategy (12-72 hours) (n = 363).
- Total screened: 1,142
- Total number of enrollees: 709
- Duration of follow-up: 30 days
- Mean patient age: 65 years
- Percentage female: 29%
- Intermediate- to high-risk NSTE-ACS
- No pretreatment with P2Y2 inhibitors
Other salient features/characteristics:
- Diabetes: 32%
- Aspirin at randomization: 44%, P2Y2 inhibitors at randomization: 21%
- NSTE myocardial infarction (STEMI): 69%; High-risk NSTE-ACS: 93%; Mean GRACE score: 122
- Angiography: No significant disease: 19%, three-vessel disease: 23%
- Percutaneous coronary intervention: 75%, coronary artery bypass grafting: 3%
The primary outcome of cardiovascular (CV) death or recurrent ischemia at 30 days, for very early vs. delayed invasive, was 4.4% vs. 21.3%, p < 0.001.
- CV death: 0.6% vs. 1.1%, p = 0.69
- Recurrent ischemia: 4.1% vs. 20.7%, p < 0.001, mostly driven by symptoms of ischemia
Secondary outcomes, for very early vs. delayed invasive:
- MI: 1.2% vs. 0.8%, p = 0.72
- Bleeding Academic Research Consortium (BARC) bleeding ≥3: 0.3% vs. 0.8%, p = 0.62
- Length of stay: 7.5 vs. 5.8 days, p = 0.046
The results of this trial indicate that a very early invasive strategy is superior to a delayed invasive strategy in improving symptoms of recurrent ischemia among patients presenting with intermediate- to high-risk NSTE-ACS and not pretreated with P2Y2 inhibitors. No differences in hard endpoints such as CV death or MI were noted.
A few caveats exist. Although the investigators mandated that P2Y2 inhibitor pretreatment be disallowed, 21% were on P2Y2 inhibitors at the time of randomization. Similar reduction in ischemic events among high-risk patients has been noted in other trials before, including TIMACS and VERDICT, and current guidelines support an early invasive approach among the highest-risk patients.
Presented by Dr. Laurent Bonello at the American Heart Association Annual Scientific Sessions (AHA 2018), Chicago, IL, November 11, 2018.
Keywords: AHA Annual Scientific Sessions, AHA18, Acute Coronary Syndrome, Aspirin, Cardiology Interventions, Coronary Angiography, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Purinergic P2Y Receptor Antagonists
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