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Enhanced Myocardial Efficacy and Removal by Aspiration of Liberated Debris

Enhanced Myocardial Efficacy and Removal by Aspiration of Liberated Debris

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Enhanced Myocardial Efficacy and Removal by Aspiration of Liberated Debris

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  1. EMERALD Trial Enhanced Myocardial Efficacy and Removalby Aspiration of Liberated Debris Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Gregg W. Stone

  2. EMERALD Trial 505 patients presenting within six hours of chest pain onset with ≥2 mm ST elevation or left bundle branch block and planned use of primary or rescue PCI Randomized, open-label, multicenter Control No distal protection n=246 GuardWire Distal Protection 0.028” GuardWire Plus System n=252 • Endpoints: • ST resolution 30 minutes post-procedure • Infarct size assessed by Tc-99m sestamibi imaging at days 5-14 Presented at ACC Scientific Sessions 2004

  3. EMERALD Trial MACE at 30 Days p=0.79 • Visible debris was removed in 73% of patients in the GuardWire arm. • There was a significantly higher number of diabetic patients in the control arm (17.3% vs. 7.5%, p=0.001). • Use of GP IIb/IIIa inhibitors was 82.9% and 83.5% in the GuardWire and Control arms, respectively. • Major adverse cardiac events (MACE) at 30 days was similar in both groups, as were the components of MACE: death (2.1% vs. 2.9%, p=0.77), heart failure (2.1% vs. 0.4%, p=0.12), new onset hypotension (11.1% each), and readmission for left ventricular failure (0.8% vs. 0%, p=0.25). % Presented at ACC Scientific Sessions 2004

  4. EMERALD Trial Post-Procedure TIMI Frame Count p=0.48 Post-Procedure TIMI Grade 3 Flow p=0.36 Post-Procedure Myocardial Blush 3 p=0.13 % Guard Wire Control Guard Wire Control Guard Wire Control • Post-procedure epicardial flow did not differ between groups, as assessed using TIMI grade 3 flow or TIMI frame count. Myocardial blush grade 3 trended higher in the GuardWire arm. Presented at ACC Scientific Sessions 2004

  5. EMERALD Trial Mean ST Resolution p=0.39 Complete ST Resolution (≥70%) 30 Minutes Post-Procedure p=0.77 Infarct Size p=0.09 % Guard Wire Guard Wire Guard Wire Control Control Control • The frequency of complete ST resolution (≥70%) 30 minutes post-procedure did not differ between the treatment arms, nor did mean ST resolution. The other coprimary endpoint, infarct size, also did not differ between treatment groups. Presented at ACC Scientific Sessions 2004

  6. EMERALD Trial • Among patients with STEMI, use of the distal protection GuardWire device was not associated with an improvement in the primary endpoints of post-procedure ST resolution or final infarct size. • Despite the capture of visible debris in 73% of patients in the GuardWire arm, no significant measures of myocardial perfusion were observed, with only a trend toward higher rate of myocardial blush grade 3.