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Published on: November 26, 2013
Rationale and Design of a Randomized Controlled Pilot Trial to Assess Stent Retriever Thrombectomy for Thrombus
Rafail A Kotronias1, Federico Marin2, Maria Emfietzoglou3
1Oxford Heart Centre, NIHR Biomedical Research Centre, Oxford University Hospitals, Oxford, United Kingdom; Department of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom.
Insights
Stent retriever thrombectomy may improve blood flow in ST-elevation myocardial infarction (STEMI) patients by reducing clot burden more effectively than current methods. This approach aims to enhance myocardial perfusion after primary PCI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- ST-elevation myocardial infarction (STEMI) involves coronary artery blockage, leading to heart muscle damage.
- Despite artery reopening, impaired downstream perfusion affects nearly half of STEMI patients.
- Coronary microvascular injury from distal emboli is a key cause of poor perfusion, with manual aspiration showing limited efficacy.
Purpose of the Study:
- To evaluate the safety and efficacy of stent retriever-assisted thrombectomy for reducing thrombus burden in STEMI patients.
- To compare stent retriever thrombectomy against manual thrombus aspiration and stenting in acute myocardial infarction.
Main Methods:
- The RETRIEVE-AMI trial randomizes 81 STEMI patients undergoing primary PCI to three groups: PCI alone, PCI with manual aspiration, or PCI with stent retriever thrombectomy.
- Optical coherence tomography (OCT) will assess changes in thrombus burden.
- A 6-month telephone follow-up is planned.
Main Results:
- Anticipated results suggest stent retriever thrombectomy will be superior in reducing thrombotic burden.
- The study expects to demonstrate the clinical safety of this thrombectomy approach.
Conclusions:
- Stent retriever thrombectomy is hypothesized to be a safe and more effective method for reducing thrombus burden in STEMI.
- This technique may improve myocardial perfusion in patients with acute myocardial infarction.
Background:
ST-elevation myocardial infarction (STEMI) is typically caused by thrombotic occlusion of a coronary artery with subsequent hypoperfusion and myocardial necrosis. In approximately half of patients with STEMI, despite successful restoration of epicardial coronary patency, downstream myocardium perfusion remains impeded. Coronary microvascular injury is one of the key mechanisms behind suboptimal myocardial perfusion and it is primarily, yet not exclusively, related to distal embolization of atherothrombotic material following recanalization of the culprit artery. Routine manual thrombus-aspiration has failed to show clinical efficacy in this scenario. This could be related with limitations in technology adopted as well as patients' selection. To this end, we set out to explore the efficacy and safety of stent retriever-assisted thrombectomy based on clot-removal device routinely used in stroke intervention.
Study Design And Objectives:
The stent RETRIEVEr thrombectomy for thrombus burden reduction in patients with Acute Myocardial Infarction (RETRIEVE-AMI) study has been designed to establish whether stent retriever-based thrombectomy is safe and more efficacious in thrombus modification than the current standard of care: manual thrombus aspiration or stenting. The RETRIEVE-AMI trial will enrol 81 participants admitted for primary PCI for inferior STEMI. Participants will be 1:1:1 randomised to receive either standalone PCI, thrombus aspiration and PCI, or retriever-based thrombectomy and PCI. Change in thrombus burden will be assessed via optical coherence tomography imaging. A telephone follow-up at 6 months will be arranged.
Conclusions:
It is anticipated by the investigators that stent retriever thrombectomy will more effectively reduce the thrombotic burden compared to current standard of care whilst being clinically safe.
