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DEDICATION. DEDICATION. Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Leif Thuesen. DEDICATION : Background.

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Presented at the American College of Cardiology Annual Scientific Session

March, 2007

Presented by Dr. Leif Thuesen

Dedication background

DEDICATION : Background

  • The goal of this trial was to evaluate treatment with distal protection using a Filterwire compared with conventional intervention among patients with ST elevation MI undergoing percutaneous coronary intervention (PCI).

  • Another goal was to evaluate PCI with drug-eluting stents (DES) compared with bare metal stents (BMS).

ACC 2007

Dedication study design

DEDICATION : Study Design

626 patients of average age 62 years undergoing PCI and presenting with ST elevation > 4mm, symptom duration < 12 hours, and the abitilty to place the protection device distal to the culprit lesion.

Randomized. Mean follow-up 30 days.

Exclusion Criteria: left main lesion, gastrointestinal bleed in the prior month, expected survival < 1 year.


Conventional PCI


Distal Protection

using a Filterwire


Patients were further randomized to PCI using DES compared with BMS (data not shown)

  • Primary endpoint: ST resolution through 90 minutes post-PCI.

  • Secondary endpoints: Post-PCI TIMI flow grade; wall motion index at discharge; cardiac biomarker release; major adverse cardiac and cerebral events (MACCE) at 30 days.

ACC 2007

Dedication primary endpoint

DEDICATION: Primary Endpoint

  • There was no difference in ST resolution of ≥70% on continuous ischemia-monitoring through 90 min post-PCI for the distal protection compared with the conventional PCI group.

  • There was also no difference in time to ST resolution (26 min in each group).

p = 0.29

ST Resolution (%)

n = 312

n = 314

ACC 2007

Dedication results


  • There was no difference in peak CKMB (236 mcg/l vs. 238 mcg/l) or peak troponin-T (6.72 mcg/l vs. 6.69 mcg/l).

  • Post-PCI TIMI flow grade was slightly but significantly higher in the distal protection group (95% vs. 88%, p=0.01).

ACC 2007

Dedication results1


  • There was no difference in wall motion index score (1.6 each) or Left Ventricular Ejection Fraction at discharge.

  • MACCE at 30 days occurred in 5.4% of the distal protection group and 3.2% of the conventional PCI group (p=0.17).

ACC 2007

Dedication summary


  • Among patients with ST elevation MI undergoing PCI, use of a distal protection device was not associated with a difference in ST resolution or peak biomarker elevation compared with conventional PCI.

  • Prior studies of distal protection devices for primary PCI have shown limited efficacy, including the EMERALD and PROMISE trials which both showed no difference in infarct size with use of distal protection devices.

ACC 2007

Dedication summary1


  • Additionally, the PREMIAR trial showed no difference in ST resolution.

  • Based on these trials, use of a distal protection device during primary PCI does not appear efficacious.

ACC 2007

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