Gioel Gabrio Secco, MD, PhDCardiologia Interventistica

A. O. “Santi Antonio e Biagio e Cesare Arrigo”

Alessandria

ATTUALITA’ IN TEMA DI STENT

BIORIASSORBIBILI?

CardioAlessandria III

22-23 Settembre 2017

I have the following potential conflicts of interest to report

Consulting, research grants, travel reimbursement, speaker honorarium:

1. St Jude Medical

2. Biotronik

3. Boston Scientific

4. SIS Medical

5. Philips Volcano corp

6. Abbott Vascular

In the era of DESs, large-scale randomized trials and

all-comer registries have shown significant reductions

in the need for repeat revascularization

Awata M et al. J Am Coll Cardiol. 2008;52:789-90. Silber S et al. The Lancet. 2011

EV

EN

TS

YEARS

BMS

DES

II° DES

BRS

30%

15%

5%

???

Despite these improvements, newer-generation DESs have not managed to address all

the limitations of permanent coronary stents:- the persistent risks of TLR and neoatherosclerosis;

- hindrance of late lumen enlargement, and the lack of reactive vasomotion;

- the risk of VLST and its clinical sequelae, although substantially reduced still remains!

THEORETICAL BENEFITS

Reduction in long term events

Restoration of shear stress

Suitability for future treatments

Feasibility of non invasive imaging

Use in young / pediatrics subset

MANUFACTURER NAME PLATFORM THICKENESS DRUG

Abbot Absorb PLLA 157 Everolimus

Elixir DESolve PLLA 150 Novolimus

ART ART Pure PDLLA 170 -

Biotronik Magmaris Mg 150 Sirolimus

COMPOSITION ELASTICITY(GPA)

STRENGTH(MPA)

ELONGATIONAT BREAK, %

DEGRADATION TIME

PLLA 3.1 – 3.7 60 - 70 2 - 6 > 24 m

PDLLA 3.1 - 3.7 45 -55 2 - 6 6-12 m

Mg 40 - 45 220 - 330 2 - 20 1 - 3

Cobalt chromium 210 -235 1449 40 biostable

6 RCT (3738 pts) comparing the Absorb BVS with EES

NO DIFFERENCES in the rates of the composite pts & device-oriented adverse events

1 Year FU

Stone GW et al. Lancet 2016

Ali ZA et al. Lancet 2017.

PROGRESS

n=63

BIOSOLVE-I

n=46

BIOSOLVE-II

n=123

BIOSOLVE-III

n=63

12 month 36 month 12 month 6 month

TLF [%] 23.8 6.8 3.4 3.3

Scaffold ThrombosiDefinite or probable

0.0 0.0 0.0 0.0

Clinical trial

Trials Nr. paz FUP [m]

63 84

46 36

123 24

BIOSOLVE-III 63 6

Total 295

Magmaris:

Polymeric scaffold3

Magnesium

Polymer

NAME PLATFORM THICKENESS DRUG DEGRADATION

DESolve CX PLLA 120 Novolimus 2 y

Fantom Desaminotyrosinepolycarbonate with iodine

atoms

125 Sirolimus 1 – 3 y

MeRes PDLLA 100 Sirolimus 4 – 6 m; 100% 2y

FORTITUDE PLLA 150 Sirolimus 10 m

Mirage PLLA 125 Sirolimus 14 m

FireSorb PLLA 100 - 125 Sirolimus 3 y