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Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. F. Cura

PREMIAR Trial. Protection from Distal Embolization in High-Risk Patients With Acute ST-Segment Elevation Myocardial Infarction (PREMIAR) Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. F. Cura. PREMIAR Trial: Background.

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Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. F. Cura

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  1. PREMIAR Trial Protection from Distal Embolization in High-Risk Patients With Acute ST-Segment Elevation Myocardial Infarction (PREMIAR) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. F. Cura

  2. PREMIAR Trial: Background • This was a 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 percutaneous coronary intervention (PCI) for STEMI. Presented at ACC 2006

  3. PREMIAR Trial: Study Design 140 patients with STEMI <12 hours, reperfusion candidate. Excluding those with: Cardiogenic shock, CABG or PCI within last 6 months, inadequate ECG, baseline TIMI 3 flow, small vessel <2.5 mm, bifurcation (side branch >2.5 mm), multivessel PCI, LMCA stenosis, tortuosity, unable to deliver stent or device. Randomized. Over 50% with LAD as target vessel, 25% GP IIb/IIIa inhibition, use of SpideRX prolonged procedure by 10 minutes, 40-60% of filter patients with >1 branch proximal to the stenosis, mean age 60 years, mean follow-up 12 months. Primary PCI with SpideRX Embolic Protection Device n=70 Primary PCI n=70 • Primary Endpoint: Degree of ST-segment resolution by continuous Holter monitoring measured at 60 minutes. • 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 (MACE) at 30 days and 12 months. Presented at ACC 2006

  4. PREMIAR Trial: Primary Endpoint Rate of complete ST-segment resolution at 60 minutes (%) • The rate of complete ST-segment resolution at 60 minutes was 61% for placebo and 60.1% in the distal protection patients (p=NS). • Baseline characteristics were well matched and the median time from symptom onset to PCI was 150 minutes. • Baseline TIMI flow 0-1 was present in 83-85% of patients. % Presented at ACC 2006

  5. PREMIAR Trial: Secondary Endpoints • There were no differences found in ejection fraction or no-reflow. • Non-significant reductions in angiographically visible thrombosis or distal embolization with distal protection were noted. Presented at ACC 2006

  6. PREMIAR Trial: Additional Findings Device success, debris recapture, and necessary predilation (%) • The SpideRX distal protection device was used successfully in 94.3% of patients. • Debris was captured in 48.0%. • Predilation was required in 12.1%. % patients Presented at ACC 2006

  7. PREMIAR Trial: Summary • 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 MACE. Presented at ACC 2006

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