Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)

Study Overview
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Brief Summary
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The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.

Detailed Description
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Patients with first-diagnosed STEMI were randomly assigned to distal protection and thrombus aspiration (DP-TA) pretreatment during percutaneous coronary intervention (PCI) or conventional PCI (c-PCI). The primary endpoint was the remodeling index (RI), measured by cardiac magnetic resonance imaging (CMR) post-PCI and 6 months after PCI. Secondary endpoints, determined by CMR within 3 to 5 days after PCI, included the infarct ratio (infarct size to entire left ventricular [LV] size ) by delayed-enhancement (DE), area at risk (AAR) ratio (AAR to LV size) by T2 high-signal intensity , microvascular occlusion index (MVO) ratio (MVO to LV size) by DE, and myocardial salvage index (MSI, [AAR-infarct size] x 100/AAR).

Official Title
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Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction

Conditions
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ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))
* Procedure: c-PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 and less than 80 years presenting with STEMI more than 30 minutes but less than 12 hours after symptom onset with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block for whom primary PCI was intended Exclusion Criteria: included thrombolytic therapy before PCI; spontaneous restoration of coronary flow (> TIMI grade II or III); cardiogenic shock (Killip class IV); major surgery or active bleeding within 6 weeks; aspirin, thienopyridine, or heparin allergy; neutropenia (<1000 neutrophils/mm3), thrombocytopenia (<100000 platelets/mm3), hepatic dysfunction, or renal insufficiency (serum creatinine level >2.5 mg/dL [221 μmol/L]); noncardiac condition with expected survival less than 1 year; current participation in other investigations.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DP-TA<br>distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) | Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))<br>* The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration<br>* Other names: The GuardWire Plus (Medtronic Inc.);|
| Placebo Comparator: c-PCI<br>conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction | Procedure: c-PCI<br>* conventional PCI without Guard wire<br>* Other names: convenional PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postinfarct Remodeling | postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reperfusion Success | microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR | 3-5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-elevation myocardial infarction, percutaneous coronary intervention, cardiac magnetic resonance imaging, microvascular occlusion, myocardial salvage