Randomized Multicenter Trial of Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-Segment Elevation Myocardial Infarction - LIPSIA-STEMI

Jun 20, 2011
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Supported in part by a research grant from the German Heart Research Foundation and Boehringer Ingelheim GmbH, Germany.
Date Published:
01/01/2011
Date Updated:
06/20/2011
Original Posted Date:
06/20/2011
References

Description:

The goal of the trial was to evaluate a strategy of fibrinolysis and transfer for percutaneous coronary intervention (PCI) compared with transfer for primary PCI among patients with ST-segment elevation myocardial infarction (STEMI) presenting to hospitals without cardiac catheterization laboratories.

Hypothesis:

Facilitated PCI will reduce infarct size.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with STEMI within 3 hours of symptom onset

    Number of enrollees: 162
    Duration of follow-up: 30 days
    Mean patient age: 63 years
    Percentage female: 24%

Exclusions:

  • Contraindication to fibrinolysis
  • Contraindication to magnetic resonance imaging

Primary Endpoints:

  • Infarct size assessed by magnetic resonance imaging

Secondary Endpoints:

  • Microvascular obstruction
  • Early ST-segment resolution
  • Composite of death, myocardial infarction, or congestive heart failure within 30 days

Drug/Procedures Used:

Patients with STEMI within 3 hours of symptom onset were randomized in the ambulance to facilitated PCI with tenecteplase (n = 81) versus transfer for primary PCI (n = 81).

Concomitant Medications:

All patients received aspirin 500 mg, clopidogrel 600 mg, and unfractionated heparin 60 U/kg to maximum of 5000 U. Glycoprotein IIb/IIIa inhibitors were recommended in all patients at the time of PCI.

Principal Findings:

Overall, 162 patients were randomized. The mean age was 63 years, 24% were women, 36% had diabetes, anterior myocardial infarction was present in 43%, systolic blood pressure was 130 mm Hg, and median transportation distance was 92 miles. Adjuvant medications were similar between the groups, except for glycoprotein IIb/IIIa inhibitors, which were used in 29% of the facilitated group versus 88% of the primary PCI group (p < 0.001), respectively.

The time from symptom onset to balloon inflation was 158 minutes in the facilitated group versus 131 minutes in the primary PCI group (p = 0.01). TIMI flow grade 3 pre-procedure was present in 44% of the facilitated group versus 24% of the primary PCI group (p < 0.001).

The primary endpoint, infarct size, was 17.9% of the facilitated group versus 13.7% of the primary PCI group (p = 0.10). There was no difference in the primary endpoint according to prespecified subgroup analysis.

Early microvascular obstruction was 3.4% versus 1.9% (p = 0.06), late microvascular obstruction was 1.3% versus 0.9% (p = 0.09), left ventricular ejection fraction was 57.4% versus 60.3% (p = 0.72), no ST-segment recovery was 16.9% versus 12.8% (p = NS), composite adverse events were 19.8% versus 13.6% (p = 0.13), and GUSTO severe/life-threatening bleeding was 2.5% versus 2.5%, respectively, for facilitated versus primary PCI.

Interpretation:

Among patients with STEMI presenting very early from symptom onset (<3 hours), there was no benefit to fibrinolysis and transfer for PCI versus immediate transfer for primary PCI. Facilitated PCI did not improve infarct size, left ventricular ejection fraction, or clinical outcomes.

The time from symptom onset to balloon inflation was 27 minutes longer in the facilitated group in part due to the delay required to administer fibrinolytics. Despite the longer symptom to balloon time in the facilitated group, there was a 20% absolute increase in preprocedure TIMI 3 flow. The ASSENT-4 and FINESSE trials were also unable to document benefit from a facilitated PCI strategy.

References:

Thiele H, Eitel I, Meinberg C, et al. Randomized Comparison of Pre-Hospital–Initiated Facilitated Percutaneous Coronary Intervention Versus Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction Very Early After Symptom Onset: The LIPSIA-STEMI Trial (Leipzig Immediate Prehospital Facilitated Angioplasty in ST-Segment Myocardial Infarction). JACC Cardiovasc Interv 2011;4:605-614.

Keywords: Myocardial Infarction, Follow-Up Studies, Fibrinolysis, Cardiac Catheterization, Stroke Volume, Blood Pressure, Tissue Plasminogen Activator, Angioplasty, Balloon, Coronary, Diabetes Mellitus


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