ST-segment Elevation Myocardial Infarction
Conditions
Keywords
ST-elevation myocardial infarction, percutaneous coronary intervention, cardiac magnetic resonance imaging, microvascular occlusion, myocardial salvage
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).
Interventions
DEVICEdistal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))
The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration
PROCEDUREc-PCI
conventional PCI without Guard wire
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postinfarct Remodeling | 6 months | postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reperfusion Success | 3-5 days | microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR |
Countries
South Korea
Participant flow
Recruitment details
Between Jan 24, 2004, and June 16, 2008, 550 patients with STEMI were screened.
Pre-assignment details
Among them, 126 patients were randomized to receive either PCI with distal protection (n=65) or PCI alone (n=61). Fifty five patients per each group received post-PCI CMR. Forty one patients underwent 6 month MRI in distal protection group and 43 patients, in conventional PCI group.
Participants by arm
| Arm | Count |
|---|---|
| DP-TA distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) | 65 |
| c-PCI conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction | 61 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | MRI refusal | 6 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | DP-TA | c-PCI | Total |
|---|---|---|---|
| Age Continuous | 58 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 12 |
| Region of Enrollment Korea, Republic of | 65 participants | 61 participants | 126 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 52 Participants | 48 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 61 |
| serious Total, serious adverse events | 7 / 65 | 7 / 61 |
Outcome results
Primary
Postinfarct Remodeling
postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI
Time frame: 6 months
Population: Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DP-TA | Postinfarct Remodeling | 11 Number of participants with remodeling |
| c-PCI | Postinfarct Remodeling | 6 Number of participants with remodeling |
Secondary
Reperfusion Success
microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR
Time frame: 3-5 days