1. Stent design aspects
Part A – Overview
Dr. Amir Kraitzer
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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&J
1960
1977 1977 1986 1994 2003 2011 2012
CABG 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 DES
Second 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 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