الفهرس 
Introduction and aim of the workOnly 14 pages are availabe for public view
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Abstract
Summary
The use of first-generation drug-eluting stents (DES) has been associated with safety concerns such as very late stent thrombosis. Today, with the release of newer DES, there is a need for comparative studies of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) to demonstrate their value in patients with high risk of restenosis such as diabetic patients. In a satellite symposium presented at EuroPCR 2014, the Cre8™ DES was discussed. The Cre8 device has a number of unique clinical features, including polymer-free technology, abluminal reservoir technology and bio-inducer surface that ensure effective neointima suppression and rapid endothelialisation. The efficacy of the Cre8 DES has been demonstrated in the International randomised comparison between DES LimusCarbostent and Taxus drug-eluting stents in the treatment of de novo coronary lesions (NEXT) randomised clinical study, with equivalent efficacy in the diabetic patients. Ongoing clinical studies such as Investig8 have confirmed the efficacy of the device in patient populations with a high proportion of diabetic patients. The Demonstr8 randomised trial has shown almost complete Cre8 strut coverage at three months with a numerical advantage versus bare metal stent (bare metal stents [BMS] – comparator device) at one month. In addition, use of the Cre8 DES may enable a shorter duration of dual antiplatelet therapy (DAPT) following PCI. The Cre8 DES therefore represents a significant advance in stent technology and may be particularly useful in challenging clinical settings
Aim of the work:
To evaluate the safety and efficacy of a new polymer free drug eluting sent (cre8) in coronary lesions.
Methods:
This study was a prospective non-randomized study performed to assess the safety and efficacy of Cre8 PF-DES in coronary lesions. The study was conducted in a single cardiac catheterization center (Department of Cardiovascular Medicine, Beni-Suef University) from November 2014 to April 2016. This study was conducted on 100 patients with ischemic heart disease attributable to coronary lesions who underwent percutaneous coronary intervention by Cre8 polymer free drug eluting stent. 59 patients developed typical anginal pain and coronary angiography was done for them while 41 patients were asymptomatic and stress MPI was done for them.
According to the results of the coronary angiography and MPI to detect who developed MACE and those who were free of events, patients were divided into two groups group I with MACE (death, MI, TLR) and group II without MACE.
Inclusion Criteria:
Patients with ischemic heart disease who performed coronary angiography that revealed significant coronary artery disease that is eligible for percutaneous coronary intervention according to the ESC guidelines for percutaneous coronary intervention.
All types of coronary lesions (Osteal, bifurcation, LM, ect).
Exclusion Criteria:
Contraindications for cardiac catheterization.
Patients with significant coronary artery disease not amenable for PCI.
3- Contraindication for dual antiplatelet therapy for at least 6 months post PCI.
Every patient was subjected to:
1) Thorough history taking, 12-lead ECG and echocardiography.
2) Coronary angiography for symptomatic patients: Follow up coronary angiography after
6 months to assess the stent.
3) Stress myocardial perfusion imaging for asymptomatic patients : Asymptomatic patients who were enrolled in group II were subjected to stress myocardial perfusion imaging to detect any residual ischemia in the target vessel by using Stress gated SESTAMIBI scintography.
The primary endpoint was the incidence of major adverse cardiac events (cardiac death, myocardial infarction and TLR).
The secondary endpoint was the device performance and peri-procedural safety.
Results:
Follow up was done at 6 months or more after enrollment for evaluation of the previously deployed stent for detection of instent restenosis and the need for target lesion revascularization (TLR), Coronary angiography was done for 59 symptomatic patients While the asymptomatic 41 patients were followed up by stress myocardial perfusion imaging.
Accroding to the results of our asseement: 16 patients developed MACE events and 84 patients were free of events.