CẬP NHẬT về THIẾT kế STENT PHỦ THUỐC

 Once implanted into the artery, the BIOlut begins its controlled release of drug matrix gently breaks down into CO 2 and H 2 O causing minimal tissue burden and avoids inflammat

CẬP NHẬT VỀ

THIẾT KẾ STENT PHỦ THUỐC

Assoc Prof Truong Quang Binh MD., PhD., FSCAI

University Medical Center

3

Stent platform and delivery system

Eluting Stent

Pharmacologic

Garg S, et al Coronary artery stents The PCR-EAPCI Percutaneous Interventional Cardiovascular Medicine Textbook, pp 45-106 Price MJ, et al Fundamentals of Drug-Eluting Stent Design Coronary stenting: A Companion to Topol’s Textbook of Interventional

Cardiology

“ DRUG CARRIER VEHICLE” OF DES

DES with durable polymer (durable-polymer DES)

Drug Carrier

Polymer

DES with durable polymer

(durable-polymer DES)

DES with durable polymer (durable-polymer DES)

persistent arterial wall inflammation and delayed vascular healing

DES with biodegradable polymer (biodegradable-polymer DES)

 Once implanted into the

artery, the BIOlut begins

its controlled release of

drug

matrix gently breaks

down into CO 2 and H 2 O

causing minimal tissue

burden and avoids

inflammation

 Following complete

absorption of the

polymer, only a PROBIO

coated stent is left behind

Biodegradable-polymer DES

The hybrid structure:

• * Passive component

PROBIO encapsulates

the stent, eliminating

interaction between the

metal stent and the

surrounding tissue

• * Active component

BIOlut contains a

bioabsorbable polymer

matrix combined with a

limus drug for optimal

results

The underlying PRO-Kinetic

Energy Stent System provides

superior deliverability with

state-of-the-art thin strut stent design

An ideal combination of passive and active components

Industry’s first hybrid drug eluting stent

with a bioabsorbable polymer

reducing the long-term risks associated with

the presence of a permanent polymer

Porous Polymer-free Drug Eluting

Stent (polymer-free DES)

Porous Polymer-free Drug Eluting

Stent (polymer-free DES)

Bioresorbable scaffolds (BRS)

BRS can be accepted as the ultimate device for the treatment of CAD

and could be the next revolution in

interventional cardiology

Circumferential

3 µm/side

Overview of current DES stent designs

Sources: 1: GG Stefanini, M Taniwaki, S Windecker, Coronary stents: novel development, Heart doi:10.1136/heartjnl-2012-303522; 2: IT Meredith, Scientific symposium, TCT 2013

Strut and coating thickness in perspective

Absorb2

PLLA-EES

 Once implanted into the

artery, the BIOlut begins

its controlled release of

drug

matrix gently breaks

down into CO 2 and H 2 O

causing minimal tissue

burden and avoids

inflammation

 Following complete

absorption of the

polymer, only a PROBIO

coated stent is left behind

ORSIRO stent (Biotronik)

ORSIRO:

Late Loss = 0.05 Restenosis = 0%

19

Study Study design Total

patients

Primary endpoint Status

ClinicalTrials.gov Identifier:

FIM 30 9 mo LLL Primary endpoint reached NCT01214148

RCT vs Xience Prime 440 9 mo LLL Primary endpoint reached NCT01356888

International registry 1,000 12 mo TLF Primary endpoint reached NCT01553526

Satellite registries (8) >3,000 12 mo TLF Enrolling *

RCT vs Xience Prime 555 12 mo TVF Enrolling NCT01939249

Indian single-armed trial 120 9 mo LLL Primary endpoint reached NCT01426139

RCT vs Pantera Lux in ISR 210 6 mo LLL Enrolling NCT01651390

RCT vs Xience Prime 2,100 12 mo TLF Enrollment completed NCT01443104

SORT OUT VII RCT vs Nobori 2,314 12 mo TLF Enrollment completed NCT01879358

BIO-RESORT RCT vs Synergy & Resolute integrity 3,530 12 mo TVF Enrolling (n=1,779; 20 May 2014) NCT01674803

ORIENT RCT vs Resolute Integrity 345 9 mo LLL Enrolling NCT01826552

PRISON-IV RCT vs Xience Prime 330 9 mo LLL Enrolling NCT01516723

HAT-TRICK-OCT RCT vs Endeavor Resolute 40 3 mo Strut coverage Primary endpoint reached NCT01391871

ORSIRO OCT RCT vs Xience Prime 60 6 & 24 mo Strut coverage Enrolling NCT01594736

The clinical program for Orsiro is

comprehensive and well underway

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Clinical follow-up at 12 months

Clinical follow-up at 1 and 6- months

440 Patients with stable CAD

Clinical, angiographic, IVUS* and OCT*

Clinical follow-up to 5 years

Source: S Windecker, Late breaking trial presentation, EuroPCR 2013

Xience Prime

DESIGN

An international, RCT comparing the

Orsiro hybrid DES to Xience Prime

OBJECTIVE

To compare the Orsiro stent with a

bioabsorbable polymer to the XIENCE

with respect to non-inferiority for

in-stent Late Lumen Loss (LLL) at

9-months

PRIMARY ENDPOINT

In-Stent Late Lumen Loss at 9-month

IVUS: n=32 OCT: n=37

Patient Flow

* ITT= Intention to treat

Source: S Windecker, Late breaking trial presentation, EuroPCR 2013

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Orsiro (n=298)

Xience Prime (n=154) Age, years mean ± SD 62.7 ± 10.4 64.8 ± 9.2 Gender male (%) 78.2 74.7

History of stroke TIA (%) 7.0 6.5

Baseline clinical and lesion

characteristics

Source: S Windecker, Late breaking trial presentation, EuroPCR 2013

0.10 ± 0.32 0.11 ± 0.29 < 0.0001

In-stent late lumen loss at 9 months (mm)

Source: S Windecker, Late breaking trial presentation, EuroPCR 2013

24

Orsiro (n=278 Lesions)

Xience Prime (n=149 Lesions)

TLF, composite of cardiac death, target vessel MI (Universal Definition),

clinically driven TLR and emergent CABG - time to first event

All events have been adjudicated by an independent clinical event committee

(%)

Source: S Windecker, Scientific Symposia presentation, TCT 2013

Days after PCI

Source: M Sabaté, Scientific presentation, EuroPCR 2014

7.4%

12.3%

Days after PCI

28

Orsiro Xience Prime P

Well-apposed struts 98.6% 98.8% 0.62 Incomplete Strut

Apposition 1.0% 0.6% 0.32 Non-apposed side

branch 0.4% 0.6% 0.37

Covered Struts 98.3% 97.5% 0.042

OCT results at 9 months

Mean value 1.00± 0.44 mm 2

Stent apposition by IVUS

at 9-month FUP was 100%

in both study arms

Source: S Windecker, Late breaking trial presentation, EuroPCR 2013

Orsiro performs as best in class

Prime stent (with a durable polymer) for the in-stent late loss at 9 months

with both ORSIRO and XIENCE Prime

through 9 months

Chân thành cảm ơn quý vị

ORSIRO stent The other stents

DOCTOR