Study Design

• Randomized
• Blinded
• Parallel
• Factorial

Patient Populations:

• Age >18 years
• STEMI symptoms >30 minutes, with anticipated symptom onset to device time ≤5 hours
• Infarct artery located in the proximal or mid LAD coronary artery, with TIMI 0/1/2 flow at the time of initial diagnostic angiography (prior to wire passage)
• Based on coronary anatomy, PCI is indicated for revascularization
• Only one epicardial coronary artery will be treated
• Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification)
  
  Number of screened applicants: 6,318
  Number of enrollees: 452
  Duration of follow-up: 30 days
  Mean patient age: 60 years
  Percentage female: 73%
  Ejection fraction: 40%
  

Exclusions:

• Prior MI, or known prior systolic dysfunction (known ejection fraction <40% by any prior measure or regional wall motion abnormalities)
• An elective surgical procedure is planned that would necessitate interruption of antiplatelet agents during the first 12 months post-enrollment
• Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the acute MI
• Subject has previously undergone an angioplasty or stenting procedure in the LAD artery
• Definite planned use of aspiration, atherectomy, thrombectomy, and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration)
• Any contraindication to undergo MRI
• Multivessel intervention required during the index procedure
• Severe vessel tortuosity, diffuse disease, or severe calcification is present, which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export^® Aspiration Catheter
• Features are present, which are highly unfavorable for PCI
• Target lesion is present within a bypass graft conduit
• MI is due to thrombosis within or adjacent to a previously implanted stent
• Left ventriculography demonstrates severe mitral regurgitation or a ventricular septal defect
• Unprotected left main stenosis >40% or that will require intervention
  

Primary Endpoints:

• Infarct size (percentage of total left ventricular mass) at 30 days

Secondary Endpoints:

• MACCE (death/MI/stroke/clinically driven target vessel revascularization) at 30 days

Drug/Procedures Used:

Patients undergoing PPCI for anterior STEMI and proximal or mid left anterior descending (LAD) occlusion were randomized in a 2 x 2 fashion to receive either intracoronary abciximab versus no abciximab, and manual aspiration thrombectomy versus thrombectomy. Manual thrombus aspiration was performed with a 6 F Export Catheter (Medtronic). To ensure high intrathrombus drug concentrations, a 0.25 mg/kg bolus of abciximab was administered locally at the site of the infarct lesion via the ClearWay RX Local Therapeutic Infusion Catheter, a microporous “weeping” PTFE balloon mounted on a 2.7F rapid exchange catheter (Atrium Medical). An abciximab infusion after PCI was allowed only for refractory intraprocedural thrombotic complications.

Concomitant Medications:

All patients were administered aspirin, 324 mg orally or 250-500 mg intravenously, and clopidogrel, 600 mg, or prasugrel, 60 mg, after which emergent coronary arteriography and left ventriculography were performed. Patients undergoing PCI received procedural anticoagulation with bivalirudin (intravenous bolus 0.75 mg/kg plus infusion of 1.75 mg/kg/h, discontinued at procedure end) without routine glycoprotein IIb/IIIa inhibition. Unfractionated heparin was used in 64% of the patients prior to diagnostic catheterization.