The Supralimus (R) sirolimus-eluting stent

dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorLEMOS, Pedro A.
dc.contributor.authorBIENERT, Igor
dc.date.accessioned2013-09-23T16:53:31Z
dc.date.available2013-09-23T16:53:31Z
dc.date.issued2013
dc.description.abstractThe use of biodegradable polymeric coatings has emerged as a potential bioengineering target to improve the vascular compatibility of coronary drug-eluting stents (DESs). This review summarizes the main features and scientific facts about the Supralimus (R) sirolimus-eluting stent (Sahajanand Medical Technologies Ltd, Surat, India), which is a biodegradable polymer-based, sirolimus-eluting metallic stent that was recently introduced for routine use in Europe. The novel stent is built on a stainless steel platform, coated with a blend of biodegradable polymers (poly-l-lactide, poly-dl-lactide-co-glycolide and polyvinyl pyrrolidone; coating thickness is 4-5 mu m). The active agent is the antiproliferative sirolimus in a dose load of 1.4 mu g/mm(2), which is released within 48 days. The Supralimus stent was initially evaluated in the single-arm SERIES-I study, which showed binary angiographic restenosis rates of 0% (in-stent) and 1.7% (in-segment) and an instent late lumen loss of 0.09 +/- 0.28 mm. The multicenter randomized PAINT trial compared two DESs with identical metallic platforms and biodegradable polymer carriers, but different agents (Infinnium (R) [Sahajanand Medical Technologies Pvt Ltd] paclitaxel-eluting stent or Supralimus sirolimus-eluting stent) against bare stents. After 3 years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9 vs 7.1%; p = 0.6), but a lower risk of repeat interventions (10 vs 29.9%; p < 0.01) than controls with bare stents. The incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (1st year: 1.8%; 2nd year: 0.4% and 3rd year: 0%). These results demonstrate that the novel Supralimus stents are effective in reducing reintervention, while potentially improving the safety profile by decreasing the risk of late-term thrombosis, even though further studies would be necessary to confirm these findings.
dc.description.indexMEDLINE
dc.identifier.citationEXPERT REVIEW OF MEDICAL DEVICES, v.10, n.3, p.295-300, 2013
dc.identifier.doi10.1586/ERD.12.91
dc.identifier.issn1743-4440
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/2352
dc.language.isoeng
dc.publisherEXPERT REVIEWS
dc.relation.ispartofExpert Review of Medical Devices
dc.rightsrestrictedAccess
dc.rights.holderCopyright EXPERT REVIEWS
dc.subjectangioplasty
dc.subjectatherosclerosis
dc.subjectbiodegradable
dc.subjectcoronary
dc.subjectrestenosis
dc.subjectstent
dc.subject.otherpaint randomized-trial
dc.subject.otherfollow-up
dc.subject.otherbiodegradable polymers
dc.subject.otherbare metal
dc.subject.otherimplantation
dc.subject.otherpaclitaxel
dc.subject.otherthrombosis
dc.subject.otherdisease
dc.subject.otherlactide
dc.subject.other1-year
dc.subject.wosEngineering, Biomedical
dc.titleThe Supralimus (R) sirolimus-eluting stent
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.author.externalBIENERT, Igor:Univ Sao Paulo, Sch Med, Dept Intervent Cardiol, Heart Inst InCor, Sao Paulo, Brazil; Marilia State Sch Med, Dept Intervent Cardiol, Sao Paulo, Brazil
hcfmusp.citation.scopus10
hcfmusp.contributor.author-fmusphcPEDRO ALVES LEMOS NETO
hcfmusp.description.beginpage295
hcfmusp.description.endpage300
hcfmusp.description.issue3
hcfmusp.description.volume10
hcfmusp.origemWOS
hcfmusp.origem.pubmed23597097
hcfmusp.origem.scopus2-s2.0-84877897256
hcfmusp.origem.wosWOS:000319048400009
hcfmusp.publisher.cityLONDON
hcfmusp.publisher.countryENGLAND
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