Pre-hospital fibrinolysis versus pre-hospital fibrinolysis plus PCI - Pre-hospital fibrinolysis versus pre-hospital fibrinolysis plus PCI
The goal of the trial was to evaluate pre-hospital fibrinolysis with retaplase and a glycoprotein IIb/IIIa inhibitor followed by medical management compared with pre-hospital fibrinolysis with retaplase and a glycoprotein IIb/IIIa inhibitor followed by percutaneous coronary intervention.
Patients Enrolled: 164
Mean Follow Up: 6 months
Symptoms for ≥30 minutes and <6 hours with ST-segment elevation ≥0.1 mV in two or more extremity leads or ≥0.2 mV in two or more pre-cordial leads.
Hemorrhagic stroke, ischaemic stroke within 3 months, active bleeding, non-compressible vascular punctures, history of major trauma or surgery <30 days, active peptic ulcer, neoplasms, uncontrolled hypertension >200 mmHg, suspected aortic dissection, cardiogenic shock, and pregnancy.
Final infarct size
ST-segment resolution at 90 minutes
Infarct size assessed by the area under the curve of the creatine kinase release for measurements obtained every 6 h over 3 days
Composite of death, reinfarction, disabling stroke, and major bleeding within 30 days and 6 months after randomization.
Patients with ST elevation MI were randomized to either pre-hospital combination-fibrinolysis (half-dose reteplase with abciximab) with standard care medical care (n=82) or pre-hospital combination-fibrinolysis with facilitated PCI (n=82). Rescue PCI for the medical therapy arm was indicated in the presence of ST resolution of <50% at 90 minutes or persistent angina. Angiography was recommended prior to hospital discharge.
All patients were to receive beta-blockers, ACE-inhibitors, statin and aspirin. Clopidogrel was used in 77% of the pre-hospital combination-fibrinolysis group and 88% of the facilitated PCI group.
All patients received the pre-hospital combination-fibrinolytic. In the facilitated PCI group, 96% had PCI performed. Prior to PCI, TIMI flow grade 3 was present in 69% of the facilitated PCI group, and TIMI 2 flow in 10%. Median time from hospital arrival to PCI was 63 minutes. Rescue PCI was performed in 18% of patients in the combination fibrinolysis group, and 73% underwent PCI prior to discharge.
The primary endpoint of infarct size was lower with facilitated PCI compared with pre-hospital combination-fibrinolysis (5.2% vs 10.4%, p=0.001). ST segment resolution occurred more frequently with facilitated PCI (80.0% vs 51.9%, p<0.001). Major bleeding did not differ by treatment group (n=4 with facilitated PCI vs n=5 with pre-hospital combination fibrinolysis). At 6 month follow-up, the composite of death, reinfarction, stroke or major bleeding was non-significantly lower in the facilitated PCI group (15.0% vs 25.3%, p=0.10).
Among patients with ST elevation MI, pre-hospital combination-fibrinolysis followed by facilitated PCI was associated with smaller infarct size compared with pre-hospital combination-fibrinolysis alone.
Prior studies comparing facilitated PCI with fibrinolysis have had some limitations, including lack of adequate anti-platelet therapy. The present study provided near-optimal medical management, with early, pre-hospital adminstration of both fibrinolytic and glycoprotein IIb/IIIa inhibitor, high use of clopidogrel, and use of beta-blockers, ACE-inhibitors, statins, and aspirin in nearly all patients. The one potential limitation of the medical management group was the use of half-dose reteplase rather than full dose. Despite the optimal medical management, facilitated PCI was associated with improved infarct size, ST resolution and a trend toward improved clinical outcomes without increased bleeding.
Thiele H, et al. Comparison of pre-hospital combination-fibrinolysis plus conventional care with pre-hospital combination-fibrinolysis plus facilitated percutaneous coronary intervention in acute myocardial infarction. European Heart Journal (2005) 26, 1956–1963
Keywords: Stroke, Follow-Up Studies, Platelet Aggregation Inhibitors, Ticlopidine, Blood Platelets, Immunoglobulin Fab Fragments, Fibrinolytic Agents, Purinergic P2Y Receptor Antagonists, Stents, Percutaneous Coronary Intervention, Fibrinolysis, Recombinant Proteins, Tissue Plasminogen Activator
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