Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Myocardial Salvage Index assesed by CMR
研究概览
简要总结
Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial infarction (AMI).
Timely restoration of perfusion and thereby myocardial salvage is the single most important objective in the management of patients with ST segment-elevation myocardial infarction (STEMI).
To address these uncertainties, our study aims to evaluate the role of RT in patients who are most likely to benefit from it (thrombus grade 4 and 5) using a sensitive, quantitative, and reproducible parameter; CMR-derived myocardial salvage. also, to determine whether Rheolytic Thrombectomy (RT) before conventional PCI to the culprit vessel as compared to conventional PCI (with or without MTA) results in improved myocardial salvage; and to identify clinical and angiographic determinants of any difference observed between both treatment groups.
详细描述
Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial infarction (AMI) , , . Timely restoration of perfusion and thereby myocardial salvage is the single most important objective in the management of patients with ST segment-elevation myocardial infarction (STEMI).
Primary percutaneous coronary intervention (PCI) is now the preferred treatment for STEMI patients and is effective in opening the infarct-related artery (IRA) and restoring Thrombolysis in Myocardial Infarction (TIMI) III flow in more than 95% of patients , , . However the presence of a large thrombus burden increase the incidence of adverse outcomes including persistent or transient no-reflow and in-hospital major adverse cardiac events (MACEs), possibly due to distal atherothrombotic embolization, with ensuing disruption of the microvascular network and failure of myocardial reperfusion . The microvascular obstruction occurs in 10% of STEMI patients with a patent epicardial vessel after primary PCI , , . It is associated with an increased infarct size, reduced recovery of ventricular function, and increased mortality , , , , , , .
Removal of thrombi from the IRA during primary PCI may prevent distal embolization and improve myocardial perfusion and thus long term clinical outcomes. However studies conducted to date provide mixed results , , , , , .The two largest randomized trials to date comparing manual thrombus aspiration (MTA) followed by PCI to PCI only are the Thrombus Aspiration during PCI in Acute Myocardial Infarction (TASTE) study , and Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction (TAPAS) study , . They further illustrate the existing uncertainties.
TAPAS study showed improvement of the myocardial blush grade (primary endpoint) and reduction of cardiac mortality at one year follow up in patients of the MTA group compared to those in the conventional-PCI group. However, it is important to note that TAPAS was not powered to detect differences in clinical outcome. TASTE study showed no mortality benefit of MTA at one year follow up. These results concluded that routine use of thrombus aspiration is not supported by current evidence however, selective use may improve tissue perfusion in some patients .Accordingly MTA is currently a class IIb recommendation in the European Society of Cardiology (ESC) guidelines for myocardial revascularization in STEMI patients , and a class IIa recommendation in the 2013 ACC/AHA STEMI guidelines . The latter was released before the results of TASTE were published.
MTA is ineffective in ≈30% of patients. Furthermore, residual thrombi after MTA are present in virtually all patients when studied by optical coherence tomography (OCT).27, . The currently existing alternative technique for removal of intracoronary thrombi is the Rheolytic Thrombectomy (RT) by Angiojet device. RT is a catheter-based system that utilizes multiple high-velocity, high-pressure saline jets introduced through orifices in the distal tip of the catheter to create a localized low-pressure zone (Venturi-Bernoulli effect), resulting in a vacuum effect with the entrainment and dissociation of bulky thrombi. The jets break down thrombi into small particles and propel them proximally through the exhaust lumen, leading to the aspiration and removal of thrombotic debris without embolization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI with time from symptom onset of <12 hours duration.
- •STEMI with time from symptom onset < 24 hours, in the presence of ongoing ischaemia, life-threatening arrhythmias or if pain and ECG changes have been stuttering.
排除标准
- •Clinical exclusion criteria:
- •STEMI patients receiving fibrinolytic therapy.
- •Cardiogenic shock.
- •Patients with clinical, hemodynamic, or electrical instability as well as those judged to be critically ill or when there is need to minimize the procedure length to the shortest possible time.
- •Patients refusing to participate in the study.
- •Angiographic exclusion criteria:
- •Infarct artery reference vessel diameter <2.5 mm on visual assessment.
- •Previously stented infarct artery.
- •TIMI thrombus grade <
- •Inability to identify the infarct artery.
- •Contraindications to adenosine:
- •Second or third degree atrioventricular block
- •Sick sinus syndrome
- •Systolic blood pressure less than 90 mm Hg
- •Sinus bradycardia (heart rate<40 bpm)
- •Active bronchospastic disease with regular use of inhalers
- •Known hypersensitivity to adenosine
- •Contraindications to CMR :
- •Cerebral aneurysm clips
- •MRI non compatible cardiac pacemaker
- •Implanted cardioverter-defibrillator
- •Retained transvenous pacemaker and defibrillator leads
- •Electronic implant or device, eg, insulin pump or other infusion pump
- •Cochlear, otologic, or other ear implant
- •Shunt (spinal or intraventricular)
- •Tissue expander (eg, breast)
- •Joint replacement (eg, hip, knee, etc)
- •Any type of prosthesis (eg, eye, penile, etc)
- •Known claustrophobia
- •Body piercing jewelry
- •Known/possible pregnancy or breast feeding.
结局指标
主要结局
Myocardial Salvage Index assesed by CMR
时间窗: 48 hours after the Intervention and after 3 month of the STEMI.
Myocardial salvage index (MSI) will be determined as the difference between the area at risk and the total infarct area divided by the area at risk.
次要结局
- ST segment resolution(after 60 minutes of the procedure)
- Corrected TIMI frame count(During the coronary angio to assess flow after the procedure.)