title: 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).
abstract: OBJECTIVE
  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).
authors.affiliation: Department of Internal Medicine/Cardiology, University of Leipzig-Heart Center, Leipzig, Germany. thielh@medizin.uni-leipzig.de
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
authors.forename: Claudia
authors.initials: C
authors.lastname: Meinberg
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.forename: Anja
authors.initials: A
authors.lastname: Leuschner
authors.forename: Dietrich
authors.initials: D
authors.lastname: Pfeiffer
authors.forename: Andreas
authors.initials: A
authors.lastname: Hartmann
authors.forename: Ulrich
authors.initials: U
authors.lastname: Lotze
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Strauss
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D016001:Confidence Intervals; D004562:Electrocardiography; D004632:Emergency Medical Services / Q000379:methods*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006352:Heart Ventricles; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000628:therapy*; D015425:Myocardial Reperfusion; D012307:Risk Factors; D013686:Telemetry / Q000295:instrumentation; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents