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