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)

Study Questions:

What is the role of facilitated percutaneous coronary intervention (PCI) in patients presenting early, but facing long transfer time for primary PCI?

Methods:

The authors performed a randomized trial to evaluate the role of fibrinolytic therapy-based facilitated PCI in patients with ST-segment elevation myocardial infarction who present within 3 hours of symptom onset. Patients were randomized to either prehospital-initiated facilitated PCI using tenecteplase (n = 81) or primary PCI (n = 81). The primary endpoint was infarct size assessed by delayed-enhancement magnetic resonance imaging. Secondary endpoints were microvascular obstruction and myocardial salvage, early ST-segment resolution, and a composite of death, repeated myocardial infarctions, and congestive heart failure within 30 days.

Results:

The total time from symptom onset to PCI was slightly longer in the facilitated PCI arm (158 vs. 131 minutes). Facilitated PCI was associated with better preinterventional TIMI (Thrombolysis In Myocardial Infarction) flow, but the infarct size tended to be worse in this population (17.9% of left ventricle vs. 13.7% p = 0.10). There was no difference in ST-segment resolution (p = 0.26). The combined clinical endpoint showed a trend toward higher event rates (19.8% vs. 13.6%; p = 0.13; relative risk, 0.52; 95% confidence interval, 0.23-1.18).

Conclusions:

There was no benefit of facilitated PCI in patients presenting early after symptom onset and being transferred for primary PCI.

Perspective:

Facilitated PCI appears to be a logical strategy, but has consistently failed when tested in randomized settings. The results of this study essentially mirror those of the larger FINESSE trial (Ellis SG, et al., N Engl J Med 2008;358:2205-17), and there is no role for facilitated PCI in contemporary clinical practice.

Keywords: Thrombolytic Therapy, Myocardial Infarction, Heart Failure, Angioplasty, Magnetic Resonance Imaging, Percutaneous Coronary Intervention


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