Coronary Stent - Part A - Overview
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  • 1. Stent design aspects Part 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 Disease Coronary artery disease (CAD) is leading cause of death world-wide CAD deaths estimated 1 in 5 annually Costs $151.6 billion in 2007 1995 – 2005: 34% decline in CAD death Initial Stenosis * Statistics were taken from American Heart Association
  • 3. Historical background Andreas Jacques Puel Julio Palmaz Cypher, Abbott Gruentzig Ulrich Sigwart Richard Schatz J&J1960 1977 1977 1986 1994 2003 2011 2012CABG Angioplasty Stent First FDA First FDA First CE Research FIM Approved Approved approved Pro-healing Stent DES DEBDS
  • 4. Restenosis Re-narrowing of a blood vessel causing a reduction of the luminal size Driver of restenosis recoil 40%revascularization mechanical stabilization of Need for acute result neointima formation 20% local delivery of anti-proliferative agents 5% implantation technique PTCA 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) - Paclitaxel 2006 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-eluting biodegradable stent, ABSORB ABSORB, Abbott (2011) - Everolimus
  • 10. Current and Future Research Biodegradable Stents Pro-healing approach
  • 11. Clinical restenosis measurement definitions Measurement 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 of treatment Late lumen loss The 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 restenosis Angiographic measurement during follow-up as stenosis in the treated segment including the 5mm 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 target lesion/vessel revascularizations Stent Thrombosis Basically 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 included all unexplained deaths occurring early (<30 days), late (31 to 360 days), or very late (>360 days) after the procedure