Acute Myocardial Infarction
Conditions
Keywords
Thrombus aspiration, Percutaneous coronary intervention
Brief summary
The present study was designed to investigate whether the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary percutaneous coronary intervention (PCI) in acute myocardial infarction improve clinical outcomes.
Detailed description
Primary percutaneous coronary intervention (PCI) is the preferred strategy for immediate revascularization in patients with acute ST-elevation myocardial infarction (STEMI). A meta-analysis of trials comparing primary PCI to fibrinolytic therapy showed a mortality benefit to the invasive approach. However, although TIMI III flow is achieved in the culprit epicardial vessel in the majority of patients, lack of tissue-level reperfusion is observed in approximately 30% of patients as manifested by persistence of chest pain and ST-segment elevation. Many strategies have tried to overcome this problem, from mechanical thrombectomy and distal protection devices to myocardial preserving agents. The purpose of present study is to investigate the efficacy of the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary PCI in acute myocardial infarction.
Interventions
DEVICEEndeavor resolute or Resolute integrity (Medtronic)
PCI without thrombus aspiration
DEVICEExport Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
PCI after thrombus aspiration
Sponsors
Medtronic
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset * Patients who are eligible for PCI
Exclusion criteria
* History of bleeding diathesis or coagulopathy * Pregnant * Known hypersensitivity or contra-indication to contrast agent * Left main disease * In-stent restenosis lesion * Graft vessels lesion * Chronic total occlusion lesion * Renal dysfunction, creatinine more than 2.0 mg/dL * Contraindication to aspirin, clopidogrel or cilostazol * Prior PCI or bypass surgery * Old myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization | 12 months after index procedure |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death | 1 month until 12 months after index procedure |
| Myocardial infarction(Q or non-Q) | 1 month until 12 months after index procedure |
| Stent thrombosis by Academic Research Consortium definition | 1 month until 12 months after index procedure |
| Target vessel revascularization (clinically- and ischemia-driven) | 1 month until 12 months after index procedure |
| All-cause Death | 1 month until 12 months after index procedure |
| Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade | Day 0 (during PCI procedure) |
| Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades | Day 0 (during PCI procedure) |
| Left ventricular wall motion improvement | 12 months |
| ST segment resolution on ECG after procedure | 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure |
| Target lesion revascularization (clinically- and ischemia-driven) | 1 month until 12 months after index procedure |
Countries
South Korea
Outcome results
None listed