Stent Versus Thrombolysis for Occluded Coronary Arteries in Patients With Acute Myocardial Infarction 1 - STOP-AMI 1
The STOP-AMI 1 trial was a randomized trial designed to compare coronary stenting plus glycoprotein IIb/IIIa inhibition using abciximab to fibrinolytic therapy with alteplase in patients with ST-elevation myocardial infarction (STEMI).
In patients with STEMI, stenting plus abciximab would result in greater myocardial salvage as assessed by myocardial salvage index on radionucleotide scintigraphy compared to fibrinolytic therapy.
Patients Enrolled: 140
Mean Follow Up: 6 months
Mean Patient Age: median 60 years
Patients presenting within 12 hours after the onset of symptoms, chest pain for at least 20 minutes, and ST-segment elevation of at least 0.1 mV in two or more limb leads or at least 2 mV in two or more contiguous precordial leads on the surface electrocardiogram
Stroke within three months; active bleeding or bleeding diathesis; trauma or major surgery within one month; suspected aortic dissection; noncompressible vascular punctures; oral anticoagulant therapy with coumarin derivatives; or severe, uncontrolled hypertension (systolic blood pressure >180 mm Hg unresponsive to therapy)
Myocardial salvage index, calculated as the percentage of the left ventricle that was salvaged (injection of tracer prior to therapy with imaging post-therapy compared to a second study at 10 days), divided by the percentage that was compromised by the initial perfusion defect
Composite of death, reinfarction, and stroke within six months after randomization
1) Stent + IIb/IIIa: Stenting with Guidant Multi-link stent, with additional 2500 U of heparin and abciximab (0.25 mg/kg bolus followed by infusion of 10 mcg/min). Post-percutaneous coronary intervention regimen was ticlodipine 250 mg bid and aspirin.
2) Intravenous fibrinolytic: 15 mg bolus of alteplase, followed by 0.75 mg/kg infusion for 30 minutes (max 50 mg), and 0.5 mg/kg for 60 minutes (max 35 mg). Aspirin and heparin were given post-fibrinolytic therapy.
Aspirin (500 mg) and heparin (5000 U) prior to initiation of assigned therapy
A total of 140 patients were enrolled (71 in the stenting/abciximab arm and 69 in the alteplase arm). The two arms were well-balanced, with a significantly longer time to initiation of therapy in the stenting/abciximab arm (65 vs. 30 minutes after admission, p<0.001), and a median time from onset of symptoms to treatment of 150 minutes in both arms.
Initial and 10-day radionucleotide scans were obtained in 88% of patients. The size of the initial perfusion defect was similar in both groups, but the final size of the infarct was significantly smaller among patients in the stent/abciximab group versus the alteplase group (14.3% vs. 19.4%, p=0.02).
There was a greater degree of myocardial salvage in the stent/abciximab group (16.1% vs. 7.4% of the left ventricle, p<0.001). The salvage index was significantly greater with stenting/abciximab than with alteplase (0.57 vs. 0.26, p<0.001). The composite endpoint of death, reinfarction, or stroke at 30 days was lower in the stent/abciximab group versus the alteplase group (7.0% vs. 13.0%, p=0.02).
In this 140-patient trial in STEMI, stenting with abciximab resulted in improvements in myocardial salvage and final infarct size at 10 days when compared to alteplase. There was also a decrease in the incidence of the combined endpoint of death, reinfarction, and stroke between groups (lower rates in the stenting/abciximab arm); however, the study was not adequately powered to detect a difference in clinical outcomes. It is unclear from the primary analysis of this study how longer times to treatment would affect the results.
Schomig AA, Kastrati J, Dirschinger J, et al. Coronary stenting plus platelet glycoprotein IIb/IIIa blockade compared with tissue plasminogen activator in acute myocardial infarction. Stent versus Thrombolysis for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Study Investigators. N Engl J Med 2000;343:385-91.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Platelet Aggregation Inhibitors, Heparin, Immunoglobulin Fab Fragments, Fibrinolytic Agents, Electrocardiography, Stents, Percutaneous Coronary Intervention, Chest Pain, Tissue Plasminogen Activator, Heart Ventricles, Platelet Glycoprotein GPIIb-IIIa Complex
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