TY - JOUR
T1 - Randomized comparison of pre-hospitalinitiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset
T2 - The LIPSIA-STEMI trial (Leipzig Immediate Prehospital Facilitated Angioplasty in ST-segment myocardial infarction)
AU - Thiele, Holger
AU - Eitel, Ingo
AU - Meinberg, Claudia
AU - Desch, Steffen
AU - Leuschner, Anja
AU - Pfeiffer, Dietrich
AU - Hartmann, Andreas
AU - Lotze, Ulrich
AU - Strauß, Wolfgang
AU - Schuler, Gerhard
N1 - Funding Information:
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.
PY - 2011/6
Y1 - 2011/6
N2 - 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-hospitalinitiated 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)
AB - 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-hospitalinitiated 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)
UR - http://www.scopus.com/inward/record.url?scp=79959509271&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2011.01.013
DO - 10.1016/j.jcin.2011.01.013
M3 - Journal articles
AN - SCOPUS:79959509271
SN - 1936-8798
VL - 4
SP - 605
EP - 614
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 6
ER -
