Coronary Stent - Part A - Overview

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  • 1. Stent design aspectsPart A Overview Dr. Amir KraitzerThe contents of materials available on this presentation are reserved. Content may not be reproduced,published, or transferred except with the prior written permission of Dr. Amir Kraitzer

2. Coronary Artery DiseaseCoronary artery disease (CAD) is leading cause of death world-wideCAD deaths estimated 1 in 5 annuallyCosts $151.6 billion in 20071995 2005: 34% decline in CAD deathInitial Stenosis* Statistics were taken from American Heart Association 3. Historical backgroundAndreasJacques PuelJulio Palmaz Cypher,AbbottGruentzigUlrich SigwartRichard Schatz J&J19601977 1977 19861994 20032011 2012CABG AngioplastyStent First FDA First FDA First CE ResearchFIM ApprovedApprovedapproved Pro-healingStent DES DEBDS 4. RestenosisRe-narrowing of a blood vesselcausing a reduction of theluminal size Driver of restenosisrecoil40%revascularizationmechanical stabilization ofNeed foracute resultneointima formation 20% local delivery ofanti-proliferative agents 5% implantation techniquePTCA BMS DES 5. ISR Biology 6. ISR prevention Atherectomy Mechanical techniques High-pressure stent deployment Stent sandwich Atherectomy Systemic drugs Antiplatelets Anticoagulants Temporary Local Delivery Edge Effect Brachytherapy Stents Bare metal Coated Stents Passive coating Active coating 7. Bare Metal Stent 8. Drug eluting stent (FDA approved)First generation DES Cypher, J&J (2003) Sirolimus DES Taxus, Boston Scientific (2004) - Paclitaxel2006 US coronary stent market estimated$5 billion, 90% is attributed to DESSecond generation DES Endeavor, Medtronic (2008)- Zotarolimus Xience, Abbott (2008)- Everolimus 9. Biodegradable drug eluting stent Third generation DES The first commercially approve drug-elutingbiodegradable stent, ABSORB ABSORB, Abbott (2011) - Everolimus 10. Current and Future Research Biodegradable Stents Pro-healing approach 11. Clinical restenosis measurement definitionsMeasurement Definition Target Lesion Revascularization (TLR) The rate of reported re-intervention procedures inside the target lesion Target Vessel Revascularization (TVR) The rate of re-intervention procedures inside any lesion located in the same coronary vessel oftreatmentLate lumen lossThe resulting luminal length reduction during follow-up In-stent restenosis (ISR) Angiographic measurement during follow-up as stenosis in the treated segment >50% of the treated patients In-segment restenosisAngiographic measurement during follow-up as stenosis in the treated segment including the5mm segment distal and proximal to the stent edges >50% of the treated patientsMajor Adverse Cardiac Events (MACEs)Complications in cardiac trials such as death, Q-wave and non-Q-wave infarction, and targetlesion/vessel revascularizations Stent ThrombosisBasically defined by the presence of angiographic thrombus in a stent during follow-up. However, it has variable definitions, such as probable or definite stent thrombosis. Recently, a set of definitions were developed by an academic research consortium (ARC) which includedall unexplained deaths occurring early (360days) after the procedure