Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry.
Int J Cardiol
; 283: 67-72, 2019 05 15.
Article
in En
| MEDLINE
| ID: mdl-30826192
ABSTRACT
BACKGROUND:
The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization.METHODS:
The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12â¯months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.RESULTS:
A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9⯱â¯11.2â¯years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (nâ¯=â¯88). Definite stent thrombosis occurred in 0.5% patients (nâ¯=â¯12).CONCLUSION:
The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS. GOV IDENTIFIER NCT02183454.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Product Surveillance, Postmarketing
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Coronary Artery Disease
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Registries
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Sirolimus
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Drug-Eluting Stents
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Percutaneous Coronary Intervention
Type of study:
Guideline
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limits:
Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
Int J Cardiol
Year:
2019
Type:
Article
Affiliation country:
Italy