This document discusses the potential use of bioresorbable vascular scaffolds (BRS) for treating chronic total occlusions (CTOs) and summarizes the presenter's conclusions. It outlines some benefits of BRS, such as avoiding permanent stents, but also notes challenges like weaker radial strength and risk of scaffold overlapping. Limited data on 105 patients who received BRS for CTOs showed good outcomes at 6 months. However, the presenter ultimately concludes there is currently no clear indication for using BRS rather than drug-eluting stents to treat CTO lesions, due to unresolved risks and limitations of available BRS technologies.

1. Medizinische Klinik I
Lukaskrankenhaus Neuss
BVS – An option for CTOs ?
Prof. Dr. M. Haude
Medizinische Klinik I
Städtische Kliniken Neuss
Lukaskrankenhaus GmbH
mhaude@lukasneuss.de
EURO CTO CLUB
The Experts „Live“ Workshop – Berlin, September 15 - 16

2. Medizinische Klinik I
Lukaskrankenhaus Neuss
Why considering BRS technology?
• ESC Guideline recommendation:

3. Medizinische Klinik I
Lukaskrankenhaus Neuss
Limitations of current DES technology
• Permanent implant
• Chronic mechanical stress to the artery
• Chronic vessel wall inflammation
• No vasomotion of the stented segment
• Stent fractures
• Acquired stent malapposition
• Development of neoatherosclerosis
• Prolonged DAPT (minimum 6 – 12 months)
• Stent thrombosis (especially late and very late ST)
• CT / MRI compatibility for non-invasive imaging
• Difficult surgical grafting of stented vessel segments
• Stent malapposition in pediatric indications with growing vessels

4. Medizinische Klinik I
Lukaskrankenhaus Neuss
Overview on BRS programs
4
CE

5. Medizinische Klinik I
Lukaskrankenhaus Neuss
CE marked drug eluting BRS
Available since 2012;(2015): CE 2013: CE 2017: CE 2016: CE
Material PLLA PLLA
Desaminotyrosine-derived
polycarbonate
Magnesium
Scaffolding time 6-12m 1-3m Bis zu 12m Bis zu 3m
Resorption time 3-4 years ~2 years 3-4 years 1 year
Marker Platinum Pt/Ir No marker Tantalum
Strut thickness / width [µm] 150/180 150 125 150/150
Drug Everolimus Novolimus Sirolimus Sirolimus

6. Medizinische Klinik I
Lukaskrankenhaus Neuss
Have BRS fullfilled the expectations?
 No chronic mechanic stress to the vessel wall
? No chronic inflammatory stress to the vessel wall after
resorption
 Regain of vasomotion after resorption
 No late scaffold fractures
 No late scaffold malapposition
 less device thrombosis (especially late and very late)
? Less neoartheriosclerosis
 CT/MRI compatible
? Easier bypass connection to a

7. Medizinische Klinik I
Lukaskrankenhaus Neuss
What clinical results do we have available
for the Ce-marked scaffolds?
• Safety and efficacy data from randomized trials against DES are
only available for the ABSORB BVS
• More MIs
• More scaffold thromboses
• More TLR
• Schlechterer LLL
• Not more vasomotion
• Implantation in more complex lesions (small vessels, long
lesions, STEMI etc.)
• Suboptimal implantation technique (PSP developed during the
evolution of clinical results)
ABSORB BVS (ABBOTT)
• Absorb II
• Absorb III
• Absorb – Japan
• Absorb – China
• Aida

8. Medizinische Klinik I
Lukaskrankenhaus Neuss
Why now to consider BRS for CTO treatment?
Pro arguments:
• Avoid full-metal jacket especially in long CTO
lesions
• Avoid chronic mechanical stress to the
artery
• Avoid chronic vessel wall inflammation
• Allow vasomotion of the scaffolded
segment
• Hope for less neoatherosclerosis
• CT / MRI compatibility for non-invasive
imaging
• Easier surgical grafting of the scaffolded
vessel segments
Contra arguments:
• Less radial strength of scaffolds vs DES
• More recoil, especially when implanted in
CTO recanalizations with intimal tracking
• Larger crimping profile with poorer trackability
• Often need for multiple scaffolds for long CTO
lesions
• Scaffold overlapping resulting in high
thrombosis risk
• According to scaffold absorption time, signify-
cantly longer DAPT when compared to DES
• Risk of bleeding
• No hope for return of vasomotion in CTO
lesions
• Significantly more expensive

9. Medizinische Klinik I
Lukaskrankenhaus Neuss
What data do we have for BRS in CTO lesions?
• 105 pts with CTO PCI
• Mean J-CTO score: 2.61
• 25.7% retrograde approach
• Mean scaffold length: 59.75 ± 25.85 mm
• No. of scaffolds per CTO lesion: 2.44
• Post-dilatation: 81.5%
Fam et al Eurointervention 2017; 13:355 - 363

10. Medizinische Klinik I
Lukaskrankenhaus Neuss
What data do we have for BRS in CTO lesions?
At 6-month:
• 2 MI
• 1 scaffold thrombosis
• 2 TLRs
Fam et al Eurointervention 2017; 13:355 - 363

11. Medizinische Klinik I
Lukaskrankenhaus Neuss
My personal conclusion?
• When balancing all pros and cons,
I do not see an indication for
currently available BRS in the
treatment of CTO lesions

12. Medizinische Klinik I
Lukaskrankenhaus Neuss
Many thanks for your
kind attention
BRS for CTO