Protection from Distal Embolization in High-Risk Patients With Acute ST-Segment Elevation Myocardial Infarction - PREMIAR
Randomized study assessing the safety, efficacy and performance of the SpideRX distal protection device among patients with ST elevation myocardial infarction (STEMI).
Distal protection using the SpideRX embolic protection device would improve ST segment resolution after percutanious coronary intervention (PCI) for STEMI.
Patients Enrolled: 140
Mean Follow Up: 6 months
Mean Patient Age: Mean age 60 years
STEMI with continuous chest pain for ≥30 minutes presenting within 12 hours, reperfusion candidate
Cardiogenic shock, aortic dissection, cardiac tamponade, myocarditis, revascularization by coronary bypass surgery or percutaneous intervention within 6 months, oral anticoagulation, pregnancy, known renal failure, allergy to nitinol, stainless steel, aspirin, or thienopyridine.
Degree of ST-segment resolution by continuous Holter monitoring measured at 60 minutes after PCI.
Core laboratory analysis of TIMI frame count, distal embolization and myocardial blush; ejection fraction measured by cardiac ultrasound; and major adverse cardiac events at 30 days and 12 months.
Patients were randomized to primary PCI alone (n=70) or primary PCI using the SpideRX Embolic Protection Device (n=70).
Baseline characteristics were well matched. Time from symptom onset to PCI median was 150 minutes. Baseline TIMI flow 0-1 was 84%. The LAD was the target vessel in 55%. Glycoprotein IIB/IIIA inhibition was used in 26%. Use of the SpideRX device extended procedure time by a mean of 10 minutes. The device was used successfully in 94% of patients. Visible debris was recaptured in 48%.
The rate of complete ST-segment resolution at 60 minutes was 61.2% in distal protection patients and 60.3% for the control group (p=NS). Mean ST resolution was 74.7% for the distal protection device and 74.6% for the control group. No differences in ejection fraction were observed (47.4% vs. 45.3%). The composite endpoint of death, heart failure, or reinfarction at 6 months did not differ between groups (14.3% vs. 15.7%, p = 0.81).
Among patients undergoing primary PCI for ST elevation MI, distal protection using the SpideRX distal protection filter was not associated with improvements in ST-segment resolution, infarct size or major adverse cardiac events compared with PCI without distal protection.
Cura FA, et al. Protection of Distal Embolization in High-Risk Patients With Acute ST-Segment Elevation Myocardial Infarction (PREMIAR). Am J Cardiol 2007;99:357–363.
Cura F. Presented at the Late Breaking Clinical Trials Session of the i2 Summit Scientific Session, Atlanta, Georgia. March 12, 2006.
Keywords: Myocardial Infarction, Embolic Protection Devices, Chest Pain, Heart Failure, Angioplasty, Balloon, Coronary
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