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Swedish Early Decision Trial - SWEDES
Description:
The goal of the trial was to evaluate early treatment with either fibrinolysis or percutaneous coronary intervention (PCI) with abciximab among patients with ST elevation MI.
Study Design
Study Design:
Patients Enrolled: 205
Mean Follow Up: 30 days
Mean Patient Age: Mean age 65 years
Female: 25
Patient Populations:
Presentation within 6 hours after onset of symptoms with symptom duration of ≥30 minutes and ST-segment elevation ≥2 mm in ≥2 adjacent precordial leads or ≥1 mm in ≥2 adjacent limb leads.
Exclusions:
Age ≤75 years (initiated midway through trial), blood pressure >180/110 mm Hg, known bleeding disorders, contraindication to fibrinolysis, cardiogenic shock, cardiopulmonary resuscitation lasting >10 minutes within 2 weeks before inclusion, ongoing treatment with anticoagulants, allergy to study drugs, body weight >120 kg, known renal insufficiency.
Primary Endpoints:
ST-segment resolution at 120 minutes and TIMI flow grade 5 to 7 days after randomization
Drug/Procedures Used:
Patients were randomized to thrombolytic therapy with reteplase (n=104) or abciximab and transfer to an invasive center for PCI (n=101). All patients were also treated with enoxaparin at randomization.
Concomitant Medications:
Aspirin and enoxaparin
Principal Findings:
Therapy was started pre-hospitalization in 42% of patients. There was no difference in the primary endpoint of ST resolution at 120 minutes post-randomization (64% for lytic vs 68% for abciximab plus PCI, p=0.56). The co-primary endpoint of TIMI flow grade 3 at 5-7 days was higher in the abciximab plus PCI group compared with the lytic group (71% vs 54%, p=0.04). Corrected TIMI frame count was lower in the abciximab plus PCI group compared with the lytic group (median 31 frames vs 36 frames, p=0.03). There was no difference in the 30 day composite of death, reinfarction, or stroke (8% for lytic vs 3% for abciximab plus PCI, p=NS). Rescue PCI was performed more frequently in the lytic group (23% vs 1%, p<0.001).
Interpretation:
Among patients with ST elevation MI, treatment with an early invasive strategy with abciximab plus PCI was associated with higher rates of TIMI grade 3 flow compared with thrombolytic therapy at 5-7 days, with no difference in early ST resolution.
While other studies have shown primary PCI superior to fibrinolytic therapy for STEMI, it was unknown if optimal and rapid medical therapy would alter these results. In the present study, fibrinolytic therapy was to be started as early as possible, with 42% receiving pre-hospital lytic. Despite the time delay associated with primary PCI over fibrinolytics, late epicardial flow was improved, while clinical outcomes at 30 days tended to be improved.
References:
Svensson L, et al. Comparison of very early treatment with either fibrinolysis or percutaneous coronary intervention facilitated with abciximab with respect to ST recovery and infarct-related artery epicardial flow in patients with acute ST-segment elevation myocardial infarction: The Swedish Early Decision (SWEDES) reperfusion trial. Am Heart J 2006;151:798.e1-798.e7.
Keywords: Thrombolytic Therapy, Stroke, Myocardial Infarction, Platelet Aggregation Inhibitors, Immunoglobulin Fab Fragments, Fibrinolytic Agents, Percutaneous Coronary Intervention, Enoxaparin, Fibrinolysis, Recombinant Proteins, Tissue Plasminogen Activator
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