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).
RCT Entities:
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).
Authors: Suzanne de Waha; Ingo Eitel; Steffen Desch; Georg Fuernau; Philipp Lurz; Daniel Urban; Gerhard Schuler; Holger Thiele Journal: Clin Res Cardiol Date: 2015-03-01 Impact factor: 5.460
Authors: Bernhard Jäger; Serdar Farhan; Karim Kalla; Helmut D Glogar; Günter Christ; Ronald Karnik; Georg Norman; Herbert Prachar; Wolfgang Schreiber; Alfred Kaff; Andrea Podczeck-Schweighofer; Franz Weidinger; Thomas Stefenelli; Georg Delle-Karth; Anton N Laggner; Gerald Maurer; Kurt Huber Journal: Wien Klin Wochenschr Date: 2015-07-11 Impact factor: 1.704