Use of Export in Primary Percutaneous Coronary Intervention

Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available.

Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI;

• Whether use of export catheter reduces in-hospital and short term adverse events
• Whether use of export reduces slow flow or no reflow
• Whether use of export reduces the use of intracoronary drugs
• Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events

Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.

Inclusion criteria

• Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
• Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
• Chest pain < 12 hours duration
• Total occlusion (TIMI 0 flow)
• Patients undergoing primary PCI
• Informed consent

Exclusion criteria

• Patients with prior history of cardiac related surgery or intervention
• Performance of a rescue PCI after thrombolysis
• Known existence of a disease resulting in a life expectancy of less than 6 months
• Killip class III, IV