Optimal Timing of Intervention in NSTE-ACS Without Pretreatment With P2Y12-ADP Receptor Antagonists - EARLY

Nov 11, 2018
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Presenter/Author:
Laurent bonello, MD
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
French Ministry of Health
Date Presented:
11/11/2018
Date Updated:
11/11/2018
Original Posted Date:
11/11/2018
References

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.

Description:

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.

Study Design

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%

Inclusion criteria:

  • 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%

Principal Findings:

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

Interpretation:

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.

References:

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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