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Stent design aspects Part A – Overview
Dr. Amir Kraitzer
The 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
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
* Statistics were taken from American Heart AssociationInitial Stenosis
Historical background
Abbott Cypher, J&J
Andreas Gruentzig
Julio Palmaz Richard Schatz
First FDA Approved Stent
Jacques Puel Ulrich Sigwart
1977 1977 1986 1994 2003 2011 2012
Angioplasty Stent FIM
First FDA Approved DES
1960
CABG First CE approved DEBDS
Research Pro-healing
RestenosisRe-narrowing of a blood vessel causing a reduction of the luminal size
Driver of restenosis
5%
BMSPTCA DES
Nee
d fo
r re
vasc
ular
izat
ion
recoil
neointima formation
implantation technique
mechanical stabilization of acute result
local delivery of anti-proliferative agents
40%
20%
Driver of restenosis
5%
BMSPTCA DES
Nee
d fo
r re
vasc
ular
izat
ion
recoil
neointima formation
implantation technique
mechanical stabilization of acute result
local delivery of anti-proliferative agents
40%
20%
5%
BMSPTCA DES
Nee
d fo
r re
vasc
ular
izat
ion
recoil
neointima formation
implantation technique
mechanical stabilization of acute result
local delivery of anti-proliferative agents
40%
20%
ISR Biology
ISR prevention
Mechanical techniques High-pressure stent deployment Stent sandwich Atherectomy
Systemic drugs Antiplatelets Anticoagulants
Temporary Local Delivery Brachytherapy Stents
Bare metal Coated Stents
Passive coating Active coating
Atherectomy
Edge Effect
Bare Metal Stent
Drug eluting stent (FDA approved)First generation DES Cypher, J&J (2003) – Sirolimus DES Taxus, Boston Scientific (2004) - Paclitaxel
Second generation DES Endeavor, Medtronic (2008)- Zotarolimus Xience, Abbott (2008)- Everolimus
2006 US coronary stent market estimated $5 billion, 90% is attributed to DES
Biodegradable drug eluting stent Third generation DES The first commercially approve drug-eluting
biodegradable stent, ABSORB ABSORB, Abbott (2011) - Everolimus
Current and Future Research
Biodegradable Stents Pro-healing approach
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 patients
Major 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