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

Seoul National University Bundang Hospital126 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

ST-segment Elevation Myocardial Infarction

Interventions

distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))DEVICE

The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration

c-PCIPROCEDURE

conventional PCI without Guard wire

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul Natioinal University Bundang Hospital

Seongnam, South Korea

Outcomes

Primary Outcomes

Postinfarct Remodeling

postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

Time frame: 6 months

Secondary Outcomes

Reperfusion Success

microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR

Time frame: 3-5 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.