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

Phase 4

Completed

Brief Summary: 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: 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).

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Postinfarct Remodeling	6 months	postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

Secondary Outcome Measures

Name	Time	Method
Reperfusion Success	3-5 days	microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR

Locations (1): Seoul Natioinal University Bundang Hospital
🇰🇷
Seongnam, Korea, Republic of
Seoul Natioinal University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of