Stent design aspects and coronary artery disease were discussed. Coronary artery disease is a leading cause of death worldwide. Historical developments in treatments including balloon angioplasty, bare metal stents, and drug-eluting stents were covered. Mechanisms of in-stent restenosis and approaches to prevent it such as mechanical techniques, drug coatings, and biodegradable stents were described. Clinical measures for evaluating restenosis outcomes were defined.

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