Abstract 5487: Randomized Comparison of Prehospital Initiated Facilitated PCI versus Primary PCI in Acute Myocardial Infarction With < 3 h After Symptom Onset
Background: Facilitated PCI with fibrinolysis did not show a benefit in comparison to primary PCI in recently published trials. However, a subgroup of patients with high-risk STEMI presenting early after symptom onset, treated with optimal antiplatelet co-medication, and with long transfer times might benefit from a fibrinolytic-based facilitated PCI. Aim of this multicenter trial was therefore to assess the merits of facilitated PCI versus primary PCI in a STEMI network with long transfer distances.
Methods: Patients with STEMI (< 3 h after symptom onset) were randomized to either prehospital initiated facilitated PCI using tenecteplase (group A; n=80) or primary PCI (group B; n=80). Optimal prehospital co-medication consisted of 600 mg clopidogrel loading-dose plus aspirin. Glycoprotein IIb/IIIa-inhibitors were given liberally during PCI. The primary endpoint was infarct size assessed by MRI. Secondary endpoints were microvascular obstruction and myocardial salvage assessed by MRI, ST-segment resolution at 90 min, and a composite of death, re-MI, and congestive heart failure at 30 day follow-up. Safety was assessed by major bleeding and any stroke.
Results: The median time from symptom-onset to randomization was 64 min (IQR 42; 103) in group A versus 55 min in group B (IQR 27; 91; p=0.26). The median symptom-onset to balloon time was 157 min (IQR 121; 224) versus 131 min (IQR 108; 177; p=0.03). Despite better preinterventional TIMI-flow in group A (76% versus 28% TIMI 2/3; p<0.001) the infarct size was similar in group A versus group B (14.1% of left ventricle [IQR 5.3; 26.7] versus 15.1% [IQR 7.5; 23.3]; p=0.75). There was also no difference in microvascular obstruction, myocardial salvage (p=0.65 and 0.71) and ST-segment resolution (p=0.42). For the combined clinical endpoint there was trend towards higher event rates in group A (18.9% versus 8.1%; p=0.09, relative risk 2.33, 95% confidence interval, 0.98–5.63) without a difference in major bleeding and stroke (8.2% versus 5.5%; p=0.74)
Conclusion: In patients with STEMI presenting early after symptom onset 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.