Clinical trial NCT05510661: Use of Export in Primary Percutaneous Coronary Intervention
Official title: Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Total Occlusion of Coronary Artery
Primary Percutaneous Coronary Intervention
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2022-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Manual thrombus aspiration (use of export catheter) followed by primary PCI
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post thrombus aspiration TIMI flow
timeFrame: Immediately after export/balloon
measure: Slow/No-reflow
timeFrame: Immediately after procedure
measure: Major adverse cardiac events
timeFrame: In-hospital, at 1 month, and at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
name: Dr Fiaza Farooq, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar D, Saghir T, Sial JA, Kumar R, Karim M, Huma ZE, Qamar N. Use of export vs. balloon in primary percutaneous coronary intervention, in-hospital outcomes and optimal export time. Journal of the American College of Cardiology. 2021 May 11; 77(18_Supplement_1): 1034.