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