Chandra Praveen, Kumar Tarun
Department of Intervention Cardiology, Medanta the Medicity, Gurgaon, India.
Department of Intervention Cardiology, Medanta the Medicity, Gurgaon, India.
Indian Heart J. 2014 Nov-Dec;66(6):682-5. doi: 10.1016/j.ihj.2014.10.422. Epub 2014 Dec 3.
A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.
This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days.
MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients.
Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts.
一项前瞻性、多中心、上市后监测研究，旨在评估在印度常规临床实践中植入的Superia西罗莫司洗脱冠状动脉支架系统（SSECSS）的安全性和有效性。
这是一项前瞻性、开放标签、单臂、多中心（16个地点）的上市后观察性研究，纳入在印度常规临床实践中植入Superia西罗莫司洗脱冠状动脉支架（SSECS）的患者。总共纳入了200例植入Superia西罗莫司洗脱冠状动脉支架（SSECS）的冠状动脉疾病（CAD）患者。在30天、180天以及1年和2年时通过电话或门诊进行临床评估。对50例预先选定的患者进行队列研究，在180天时进行血管造影评估。
随访12个月时MACE为1.71%。随访6个月时，节段内晚期管腔丢失为0.14，支架内为0.10mm。仅2例患者需要进行靶病变血运重建（TLR）。
Superia支架与市场上其他可生物降解聚合物支架一样安全，现在是时候推出具有薄支柱的可生物降解聚合物支架了。
