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.
