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14th VNCC Danang 10-14 Oct 2014

Bioresborbable Scaffolds in
Acute Coronary Syndromes
Koh Tian Hai
Senior Consultant, Dept of Cardiology
Senior Advisor
National Heart Centre, Singapore


Conflicts of Interest

• Abbott – trial grant & travel support
• BSC, Biosensors- travel support


2014 ESC Guideline on evaluation &
revascularisation in ACS

S Windecker , P Kolh et al. EHJ 2014; 35: 2541-2619


DES with randomised Trials with
primary clinical endpoint - ESC

S Windecker , P Kolh et al. EHJ 2014; 35: 2541-2619


Some Current BRS undergoing trials

A Lelasi & M Tespii Fut Card 2014; 10: 409-20




Attractiveness of BVS
• Vessel enlargement
• Vasomotor restoration
• Completely dissolvable- uncaging of vessel
– Feasible for future CABG options

• Permits assessment with non-invasive CT
angiography


BRS: Late Lumen Enlargement

P W Serruys at TCT 2013


Porcine Model-IVUS: Increase in Lumen
area:
BVS vs EES after 12mths
70 pigs with 109 BVS and 70 EES implanted in various arteries;
Serial angio, IVUS and histomorphometry at various timepoints 1-42 mths

JP Lane et al. JACCIntv 2014; 7: june online


Porcine IVUS : Increase in lumen area after
12mth & pulsatility with BVS vs EES after 6mth

JP Lane et al. JACCIntv 2014; 7: june online



Plaque Sealing with BRS

P W Serruys at TCT 2013


BVS Case Illustration

1

2
RCA tortuosity ++
-LAO cranial view

RCA-RAO view showing
Severe tortuosity


3

4

Trackability of BVS

Final post BVS - LAO cranial


3 Gen DES & BVS for LAD long CTO


Pre PCI CTO

Synergy Tracking

Prox LAD - BVS


Final Angio & 9mth follow-up

Final

9 mths angio


ABSORB Cohort A: MACE to 5 years
30 patient Cohort
No MACE beyond 6 months
No cardiac deaths
No Stent Thrombosis
All 18 pts with MSCT at 5yrs
show patent Scaffolds

Y Onuma et al. JACCIntv 2013; 6:999-1009


Why do we need to implant
BVS in ACS?
• Younger patients, less Coro Atherosclerosis
– Free patients from permanent stents


• Does not obviate CABG for long lesions.
• ? Long term reduction in need for antiplatelet Rx.
• ? Safety to stop all antiplatelets temporarily for
surgical procedures.
• ? Plaque sealing of vulnerable plaques.


142 ppci pts
3 groups
Non randomised

V Kocka et al. EHJ 2014l 35: 787-94


Baseline Characteristics

V Kocka et al. EHJ 2014l 35: 787-94


Prague 19: MACE outcomes at 6 mths

V Kocka et al. EHJ 2014l 35: 787-94


BRS in ACS Trials & Registries
Trial

Active MACE
arm n


ST

Control n
(non
random)

STEMI-First

49

2.6%
@ 30 days

0

123

PRAGUE-19
STEMI

41

5%
@ 6 mths

1

57

KajimaNUHCS

STEMI

11

9.1%
@ 53 days

T Gori-ACS
UAP,NSTEMISTEMI

150

10-7%
@ 30 days

3

103

J WeibeSTEMI

25

8.3%
@ 137 days

0

-


MACE

ST

p

93%

-

0.6

15.5%

2

>0.8

-


C Naber @ TCT 2014


Proportion of ACS patients in
ABSORB FIRST

C Naber @ TCT 2014



Cardiac Death & MI to 30 days

C Naber @ TCT 2014


ABSORB II
BVS VS EES

1yr secondary
clinical outcomes
501 pt, 2:1 BVS : EES
Randomised Multicentre

PW Serruys et al. Lancet; online 14 Sept 2014


ABSORB II at 1yr:
Secondary MACE Endpoints
Absorb
N=335

EES
N=166

P=0.28

PW Serruys et al. Lancet; online 14 Sept 2014



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