Protection from Distal Embolization in High-Risk Patients With Acute ST-Segment Elevation Myocardial Infarction - PREMIAR

Description:

Randomized study assessing the safety, efficacy and performance of the SpideRX distal protection device among patients with ST elevation myocardial infarction (STEMI).

Hypothesis:

Distal protection using the SpideRX embolic protection device would improve ST segment resolution after percutanious coronary intervention (PCI) for STEMI.

Study Design

Study Design:

Patients Enrolled: 140
Mean Follow Up: 6 months
Mean Patient Age: Mean age 60 years
Female: 18

Patient Populations:

STEMI with continuous chest pain for ≥30 minutes presenting within 12 hours, reperfusion candidate

Exclusions:

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.

Primary Endpoints:

Degree of ST-segment resolution by continuous Holter monitoring measured at 60 minutes after PCI.

Secondary Endpoints:

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.

Drug/Procedures Used:

Patients were randomized to primary PCI alone (n=70) or primary PCI using the SpideRX Embolic Protection Device (n=70).

Principal Findings:

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).

Interpretation:

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.

References:

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.

Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Acute Heart Failure

Keywords: Myocardial Infarction, Embolic Protection Devices, Chest Pain, Heart Failure, Angioplasty, Balloon, Coronary


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