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

Seoul National University

Status and phase

Completed

Phase 4

Conditions

ST-segment Elevation Myocardial Infarction

Treatments

Procedure: c-PCI

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01384019

SNUBH-001

Details and patient eligibility

About

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.

Full description

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).

Enrollment

126 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.