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

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

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):399-404; Tamai CCT 2004

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

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;369:1869-75 Waksman et al JACC Cardiovasc Interv. 2009 Apr;2(4):312-20

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

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

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

Case report 81 y, male Arterial hypertension, hypercholesterolemia 2 VD: PCI and ICS /BMS/ in LCx , POBA of RD1/LAD- 03.2012. Implanted permanent ECS /DDDR/ by reason of complete AV- block With restored angina than one month

Diagnostic LCx RD1/LAD

The procedure Pre-dilatation Placement

Implantation

Final

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