Protocol
- 1. THROMBUS ASPIRATION DURING ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION Protocol of a thesis submitted by: Islam Mohammed Khedr
- 2. Supervisors Prof. Dr. Mohammed Ayman Abd El-Hai Professor of cardiology and angiology, Faculty of medicine, University of Alexandria. Prof. Dr. Amr Mahmoud Thanaa Eldin Zaky Professor of cardiology and angiology, Faculty of medicine, University of Alexandria. Dr. Sherif Wagdy Ayad Lecturer in cardiology and angiology, Faculty of medicine, University of Alexandria.
- 3. Assessors Prof. Dr. Mostafa Mohammed Nawar Professor of cardiology and angiology, Faculty of medicine, University of Alexandria. Prof. Dr. Mohammed Ahmed Sobhy Professor of cardiology and angiology, Faculty of medicine, University of Alexandria.
- 4. Introduction • Thrombus aspiration is easy, quickly performed and a cheap adjunct to PCI. Thrombus aspiration has been adapted by some centers as routine, while others use this treatment at the discretion of the operator and others use it scarcely. • In the recent guidelines from the American College of Cardiology, the American Heart Association and the European society of cardiology thrombus aspiration has been upgraded to a class IIa recommendation (i.e. it is reasonable to perform the procedure) with a level of evidence: B (i.e. limited populations evaluated). In our view, evidence needs to be established before thrombus aspiration becomes routine for some and discarded by others because of the uncertainty related to evidence this far.
- 5. AIM OF THE WORK • The aim of this work is to compare mortality at 30 days (Primary endpoint) in patients with STEMI treated with PCI and manual thrombus aspiration versus PCI alone. • Secondary endpoints assessed during the index hospitalization, included complications of PCI, stroke or neurologic complications, heart failure, length of stay in the hospital and TIMI flow grade in patients with STEMI treated with PCI and manual thrombus aspiration versus PCI alone.
- 6. PATIENTS • A total of 80 patients will be included in the study. • Inclusion criteria: Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block. Correspondence between ECG findings and culprit artery pathoanatomy. A minimum of 70% stenosis in culprit artery by visual estimate. Possibility to perform thrombus aspiration. • Exclusion criteria: Need for emergency coronary artery bypass grafting. Previous randomization in the study. Prior myocardial infarction. Previous open chest surgery. Inability to perform thrombus aspiration. Inability to provide informed consent. Consent will be taken from all patients to participate in the study.
- 7. METHODS • It is a prospective, randomized clinical trial. • Patients enrolled in the study will be assigned to two well-matched groups .40 consecutive patients will undergo conventional PCI “no thrombus aspiration group” followed by another 40 consecutive patients will undergo PCI with thrombus aspiration “thrombus aspiration group”.
- 8. METHODS • All patients will be subjected to: 1. Thorough history taking with special emphasis on nature of the chest pain, cardiovascular risk factors and history of IHD. 2. Clinical examination including; pulse, blood pressure and presence of cardiac murmur, gallop or pulmonary congestion. 3. Standard 12 lead ECG for localization of MI. 4. Cardiac biomarkers. 5. Echocardiography.
- 9. METHODS 6. PCI: In all patients, initially a guidewire is passed through the culprit lesion. For patients randomized to conventional PCI, guidewire advancement is followed by balloon dilatation, balloon dilatation and stenting or direct stenting to achieve antegrade flow. For patients randomized to thrombus aspiration, guidewire passing will be followed by thrombus aspiration with an aspiration catheter. Continuous manual suction is performed using a proximal-to-distal approach, which is defined as active aspiration during initial passage of the lesion. After thrombus aspiration PCI is done as described above
- 10. METHODS 7. Post-procedure platelet inhibition: After the index PCI, lifelong acetylsalicylic acid in a dose of 75-160 mg per day and clopidogril in a dose of 75 mg per day for one year will be prescribed. Use of GP IIb/IIIa inhibitors will be according to the guidelines as bailout therapy in the event of angiographic evidence of large thrombus, slow or no-reflow and other thrombotic complications.
- 11. Thank You