Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI

Dec 01, 2011
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
01/01/2011
Date Updated:
12/01/2011
Original Posted Date:
12/01/2011
References

Description:

The goal of the trial was to evaluate timing of invasive therapy among patients with non-ST-elevation myocardial infarction (NSTEMI).

Hypothesis:

Immediate invasive therapy will reduce infarct size.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • Patients 18-90 years of age with NSTEMI

    Number of enrollees: 602
    Duration of follow-up: 6 months
    Mean patient age: 68 years
    Percentage female: 34%
    Ejection fraction: 55%

Exclusions:

  • Refractory ischemia
  • Hemodynamic instability
  • Congestive heart failure
  • Significant arrhythmia
  • Use of anticoagulation
  • Contraindication to aspirin, clopidogrel, heparin, or glycoprotein IIb/IIIa inhibitor
  • Limited life expectancy
  • Alternate diagnosis for elevated troponin

Primary Endpoints:

  • Peak CK-MB activity during hospitalization

Secondary Endpoints:

  • Death or nonfatal MI
  • Death, nonfatal MI, or refractory ischemia
  • Death, nonfatal MI, refractory ischemia, or rehospitalization for unstable angina
  • Severe/life-threatening bleeding
  • Moderate bleeding

Drug/Procedures Used:

Patients with NSTEMI were randomized to immediate invasive therapy within 2 hours (n = 201) versus early invasive therapy within 10-48 hours (n = 200) versus selective invasive therapy (n = 201).

Concomitant Medications:

All patients who underwent percutaneous coronary intervention (PCI) received aspirin, clopidogrel 600 mg, unfractionated heparin, and tirofiban.

Principal Findings:

Overall, 602 patients were randomized. The mean age was 68 years, 34% were women, 39% had diabetes, mean body mass index was 28 kg/m2, and mean left ventricular ejection fraction was 55%.

The median time to angiography was 1.1 hours in the immediate group, 18.3 hours in the early group, and 67.2 hours in the selective invasive group (p < 0.001). The proportion of patients that underwent angiography was 100% vs. 99% vs. 85%, respectively.

Peak creatine kinase-myocardial band (CK-MB) activity was 0.94 µkat/L vs. 0.78 µkat/L vs. 0.91 µkat/L, respectively. The area under the curve for CK-MB release was also similar between the groups.

In-hospital MI: 13.5% vs. 8.5% vs. 7.0% (p = 0.07). All other outcomes were reported at 6 months. MI: 16.5% vs. 10.0% vs. 8.0% (p = 0.02); death or MI: 21.0% vs. 16.0% vs. 14.5% (p = 0.17); death, MI, or refractory ischemia: 20.9% vs. 21.5% vs. 22.0% (p = 0.98); death, MI, refractory ischemia, or rehospitalization: 26.0% vs. 26.5% vs. 24.5% (p = 0.91), respectively.

Severe/life-threatening bleeding: 0.5% vs. 0.5% vs. 1.0% (p = 0.78), respectively.

Interpretation:

Among patients with NSTEMI, a strategy of immediate invasive therapy did not reduce infarct size or adverse clinical outcomes compared with early invasive therapy or selective invasive therapy. In fact, the incidence of MI was highest in the immediate invasive therapy group mainly due to periprocedural events. The rate of angiography was very high in the selective invasive group, which likely minimized the difference between this and the early invasive group.

References:

Thiele H, Rach J, Klein N, et al. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J 2011;Nov 21:[Epub ahead of print].

Keywords: Myocardial Infarction, Follow-Up Studies, Creatine Kinase, Body Mass Index, Stroke Volume, Diabetes Mellitus


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