1. My initial ABSORB experience Assoc. Prof. I. Petrov
City Clinic Sofia

2. BTI, Ideal™, Elixir Medical, Orbus etc....
Review the clinical evidence available
Historical studies
Igaki-Tamai
Current players
BVS
AMS
REVA
BTI, Ideal™, Elixir Medical, Orbus etc....
Future studies

3. Igaki-Tamai stent (Kyoto Medical Planning, Japan)
Poly-L-lactic acid (PLLA) self-expanding stent
Strut thickness of 170µm
FIM study of 50 patients (63 lesions)
1 in-hospital stent thrombosis and Q-wave MI
1 non-cardiac death
TLR (all with PCI): at 6 months 12%
at 12 months 17%
at 4 years 18%
Late loss index (in the first 15 patients) was 0.48mm at 6 months
Further studies in the SFA with this stent demonstrated feasibility and safety in deployment of these stents over a length of 70 mm – the stent has CE mark for use in PVD.
further balloon dilatation could be done with heated contrast in the balloon
Sustained increase in CSA at 6 months Struts still visible at 6 months
Limited due to poor deliverability / high profile
Tamai et al Circulation 2000;102(4): ; Tamai CCT 2004

4. Magnesium stent (AMS, Biotronik)
Balloon-expandable magnesium alloy absorbable stent
The first clinical trial was performed in 20 patients with severe PVD with disease in the proximal two-thirds of one or more infrapopliteal arteries
All were candidates for amputation and underwent PCI with the magnesium stent on a compassionate basis
Following pre-dilatation, the 3.0×15 and 3.5×15 mm AMS were successfully deployed with good angiography and ultrasound results
At 3 and 6 months post-implantation, the stent patency rates were 89% and 78%, respectively
At 3 months, USS & MRI demonstrated complete AMS absorption
At 6 months follow-up, only 1 patient required amputation

5. Ischaemia-driven TLR was 24% at 4 months, and 45% at 1 year
Magnesium stent (AMS, Biotronik)
Coronary FIM multicentre study of 63 patients – PROGRESS-AMS
The primary endpoint was MACE at 4 months and ischemia-driven TLR
Safe: no death, no MI, no stent thrombosis
The stent was well-expanded on deployment with no immediate recoil
High restenosis rate with an in-stent late loss of 1.08 ± 0.49mm
Cumulative frequency curves of in-segment luminal narrowing before, immediately after and at 4 months follow-up after AMS
Ischaemia-driven TLR was 24% at 4 months, and 45% at 1 year
Erbel et al Lancet 2007;369:
Waksman et al JACC Cardiovasc Interv Apr;2(4):312-20

6. REVA stent (Reva Medical)
Second generation stent with sirolimus on the abluminal surface
Absorption time: 4 years
Duration strength 4-6 months
FIM due to start shortly
Pollman Eurointervention Suppl 2009,F54

9. No thrombosis by ARC or Protocol
BVS stent (Abbott Vascular): Cohort B FIM trial
30 days
N=101
6 months
Cardiac death (%)
MI (all non-Q-wave) (%) 2 3
Ischaemia-driven TLR (%)
PCI
CABG
MACE (%) 5
TLF (%)
No thrombosis by ARC or Protocol
MACE: cardiac death, MI, ischemia-driven TLR
TLF: cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR

11. First 200 Pts ABSORB EXTEND Follow-up
30 Days
6 Months
Non-hierarchical
N = 200
Cardiac Death % (n)
0.5 (1)*
Myocardial Infarction % (n)
2.0 (4)
Q-wave MI
1.0 (2)
Non Q-wave MI
Ischemia driven TLR % (n)
0.5 (1)
CABG
PCI
Hierarchical MACE % (n)
2.5 (5)
Hierarchical TVF % (n)
3.0 (6)**
* Patient was treated with a metallic DES, not ABSORB
** One additional ischemia driven non-TL TVR treated by CABG
Abizaid, A., TCT, 2011

12. Case report 81 y, male Arterial hypertension, hypercholesterolemia
2 VD: PCI and ICS /BMS/ in LCx , POBA of RD1/LAD
Implanted permanent ECS /DDDR/ by reason of complete AV- block
With restored angina than one month

13. Diagnostic
LCx
RD1/LAD

14. The procedure
Pre-dilatation
Placement

15. Implantation

16. Final

17. Why degradable stents? No late adverse events: 1. Late thrombosis
2. Stent fractures
3. Hypersensitivity reaction (chronic inflammation)
Permits bypass surgery in future
Does not restrict arterial remodeling
Permits non- invasive imaging of artery