Stent design aspects Part A – Overview

Dr. Amir Kraitzer

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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