Use of Export in Primary Percutaneous Coronary Intervention (EPISOO)

National Institute of Cardiovascular Diseases, Pakistan

Status: Enrolling

Conditions: Total Occlusion of Coronary Artery; ST-segment Elevation Myocardial Infarction (STEMI); Primary Percutaneous Coronary Intervention

Treatments: Device: Balloon catheter; Device: Export Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05510661

ERC-63/2021

Details and patient eligibility

About

Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Manual thrombus aspiration (use of export catheter) followed by primary PCI

Treatment:

Device: Export Catheter

Control group

Active Comparator group

Description:

Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI

Treatment:

Device: Balloon catheter