Author + information
- Received December 23, 2010
- Accepted January 5, 2011
- Published online June 1, 2011.
- Holger Thiele, MD⁎,⁎ (, )
- Ingo Eitel, MD⁎,
- Claudia Meinberg, BSc⁎,
- Steffen Desch, MD⁎,
- Anja Leuschner, BSc⁎,
- Dietrich Pfeiffer, MD†,
- Andreas Hartmann, MD‡,
- Ulrich Lotze, MD§,
- Wolfgang Strauß, MD∥,
- Gerhard Schuler, MD⁎,
- LIPSIA-STEMI Trial Group
- ↵⁎Reprint requests and correspondence:
Dr. Holger Thiele, Department of Internal Medicine/Cardiology, University of Leipzig, Heart Center, Strümpellstrasse 39, 04289 Leipzig, Germany
Objectives This multicenter trial sought to assess the merits of facilitated percutaneous coronary intervention (PCI) versus primary PCI in an ST-segment elevation myocardial infarction (STEMI) network with long transfer distances in patients presenting early after symptom onset.
Background Facilitated PCI with fibrinolysis might be beneficial in specific high-risk STEMI situations to prevent myocardial necrosis expansion.
Methods Patients with STEMI (<3 h after symptom onset) were randomized to either pre-hospital–initiated facilitated PCI using tenecteplase (Group A; n = 81) or primary PCI (Group B; n = 81) plus optimal antithrombotic comedication. 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 median time from symptom onset to randomization was 64 min (interquartile range [IQR]: 42 to 103 min) in Group A versus 55 min in Group B (IQR: 27 to 91 min; p = 0.26). Despite better pre-interventional TIMI (Thrombolysis In Myocardial Infarction) flow in Group A (71% vs. 35% TIMI flow grade 2 or 3; p < 0.001), the infarct size tended to be worse in Group A versus Group B (17.9% of left ventricle [IQR: 8.4% to 35.0%] vs. 13.7% [IQR: 7.5% to 24.0%]; p = 0.10). There was also a strong trend toward more early and late microvascular obstruction, (p = 0.06 and 0.09) and no difference in ST-segment resolution (p = 0.26). The combined clinical endpoint showed a trend toward higher event rates in Group A (19.8% vs. 13.6%; p = 0.13, relative risk: 0.52, 95% confidence interval: 0.23 to 1.18).
Conclusions In STEMI patients presenting early after symptom onset with relatively long transfer times, a fibrinolytic-based facilitated PCI approach with optimal antiplatelet comedication does not offer a benefit over primary PCI with respect to infarct size and tissue perfusion. ([LIPSIA-STEMI] The Leipzig Immediate Prehospital Facilitated Angioplasty in ST-Segment Myocardial Infarction; NCT00359918)
- acute myocardial infarction
- percutaneous coronary intervention
- pre-hospital treatment
The study was supported in part by a research grant from the German Heart Research Foundation and Boehringer Ingelheim GmbH, Germany. The authors have reported that they have no relationships to disclose. Drs. Thiele and Eitel contributed equally to this manuscript.
- Received December 23, 2010.
- Accepted January 5, 2011.
- American College of Cardiology Foundation