The Supralimus (R) sirolimus-eluting stent
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Citações na Scopus
10
Tipo de produção
article
Data de publicação
2013
Título da Revista
ISSN da Revista
Título do Volume
Editora
EXPERT REVIEWS
Autores
BIENERT, Igor
Citação
EXPERT REVIEW OF MEDICAL DEVICES, v.10, n.3, p.295-300, 2013
Resumo
The 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.
Palavras-chave
angioplasty, atherosclerosis, biodegradable, coronary, restenosis, stent
Referências
- Baran KW, 2011, EUROINTERVENTION, V6, P949, DOI 10.4244/EIJV6I8A165
- Chin WWL, 2008, EUR J PHARM BIOPHARM, V69, P1083, DOI 10.1016/j.ejpb.2008.02.013
- Costa Jr JR, 2010, J AM COLL CARDIOL, V55, pA208
- Dani Sameer, 2008, EuroIntervention, V4, P59, DOI 10.4244/EIJV4I1A11
- Faxon DP, 2004, CIRCULATION, V109, P2595, DOI 10.1161/01.CIR.0000128517.52533.DB
- Hu XX, 2008, BIOMATERIALS, V29, P3128, DOI 10.1016/j.biomaterials.2008.04.010
- Lemos PA, 2009, ARQ BRAS CARDIOL, V93, P590, DOI 10.1590/S0066-782X2009001200006
- Lemos PA, 2004, CIRCULATION, V110, P3199, DOI 10.1161/01.CIR.0000147275.50550.68
- Lemos PA, 2012, EUROINTERVENTION, V8, P117, DOI 10.4244/EIJV8I1A18
- Lemos PA, 2009, CATHETER CARDIO INTE, V74, P665, DOI 10.1002/ccd.22166
- Lima KM, 1999, BRAZ J MED BIOL RES, V32, P171
- Liu XH, 2005, J BIOMED MATER RES A, V74A, P84, DOI 10.1002/jbm.a.30367
- Middleton JC, 2000, BIOMATERIALS, V21, P2335, DOI 10.1016/S0142-9612(00)00101-0
- Ong ATL, 2006, EUR HEART J, V27, P2996, DOI 10.1093/eurheartj/ehl357
- Serruys PW, 2007, CIRCULATION, V115, P1433, DOI 10.1161/CIRCULATIONAHA.106.666826
- Stone GW, 2007, NEW ENGL J MED, V356, P998, DOI 10.1056/NEJMoa067193
- Thakkar Ashok, 2013, Journal of Medical Devices, V7, DOI 10.1115/1.4023414
- van Domburg RT, 2005, EUR HEART J, V26, P675, DOI 10.1093/eurheartj/ehi088
- Wykrzykowska J, 2011, EUROINTERVENTION, V7, P789, DOI 10.4244/EIJV7I7A125
- Xu J, 2011, INT J CHEM, V3, P57
- Zhou ZH, 2009, POLYM-PLAST TECHNOL, V48, P115, DOI 10.1080/03602550802497206