hospital clinic i provincial, barcelona€¦ · hospital clinic i provincial, barcelona ce-mark...

Altres plataformes: situacio actual

Salvatore BrugalettaHospital Clinic i Provincial, Barcelona

CE-mark platforms

No CE-mark platforms

Altres plataformes: situacio actual

CE-mark platforms

No CE-mark platforms

Altres plataformes: situacio actual

CE-mark approved bioresorbablescaffolds

Mechanical properties

Reduced elasticity and strengthas compared to metallic stent

DESolve innovation

DESolve Nx TrialProspective one-arm study with 126 patients2-year clinical follow-up (122 patients)6-month QCA (113 patients) IVUS (40 patients)OCT follow-up (38 patients)

Abizaid JACC Intv 2016;9:565-74

DESolve Nx Trial: 6-month late loss

0.20±0.32 mm

DESolve Nx Trial: IVUS and OCT

Increase in scaffold area during 6-month

DESolve Nx Trial: 2-year ClinicalOutcomes

Fantom (Reva Medical Inc.)Optical properties comparison

Radiopaque platformEluting sirolimus

FANTOM II study (240 patients)

History of Magmaris scaffold

0.25±0.22

3.4

0.0

BIOSOLVE-II first-in-man trial (n=123 pts)

One-year TLF 3.4%. No events beyond 6M. No definite/probable ST

Magmaris vs. Absorb vs. OrsiroImmunofluorescence

Waksman R et al. Circulation Cardiovascular Interventions

Magmaris vs. Absorb vs. OrsiroImmunofluorescence

Magmaris vs. 316L-equivalentImmunofluorescence

148 patients with STEMI (< 6 hrs)1:1 randomization

MAGMARIS CohortN = 74

ORSIRO CohortN = 74

Thrombectomy +/-predilatation

Scaffolding (M-BRS) Stenting (DES)

Sizing max

+/- postdilatation / thrombectomy based on angiographic guidance

Primary endpoint: vasodilatatory response ≥ 3% after nitroglycerininjection at 1-year FU

NTG injection, OCT evaluation (subgroup 40 pacients)

Thrombectomy +/-predilatation

NTG injection, OCT evaluation (subgroup 40 pacients)

MAGSTEMI trial

CE-mark platforms

No CE-mark platforms

Altres plataformes: situacio actual

Firesorb BRS (Microport)

Clinical outcomes

OCT Data

MeRes 100 (Meril)

MeRes-1 Study (108 pts, 116 lesions)

MeRes-1 Study (108 pts, 116 lesions)

6-month OCT data 6-month Late loss

APTITUDE Sirolimus-eluting BRS(Amaranth Medical)

RENASCENT II study (60 Patients)

9-month late loss 0.19±0.26 mm

Low MACE rate (3.4%, due to 2 non-Q-wave

MI)

Scaffold stability as assessed by OCT lumen

area

High level of strut coverage (97%)

Colombo A EuroPCR 2017

Take-Home Messages

Development of other bioresorbableplatforms is slow but active, showinginteresting and favourable data

Large and randomized trials are neededto evaluate its safety and to understandwhich patient may benefit most from thistechnology