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可生物降解聚合物涂层西罗莫司洗脱冠状动脉支架系统的长期安全性和有效性评估:INDOLIMUS注册研究的1年结果

Evaluation of prolonged safety and efficacy of biodegradable polymer coated sirolimus-eluting coronary stent system: 1-year outcomes of the INDOLIMUS Registry.

作者信息

Rajasekhar Durgaprasad, Vanajakshamma Velam, Vidyasagar Akula, Ranganayakulu Kummaraganti Paramatma, Babu Mannuva Boochi, Sivasankara Chakali, Kothari Shivani, Thakkar Ashok

机构信息

1 Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, India ; 2 Department of Clinical Trials, Sahajanand Medical Technologies Pvt. Ltd., Surat, Gujarat, India.

出版信息

Cardiovasc Diagn Ther. 2015 Aug;5(4):249-53. doi: 10.3978/j.issn.2223-3652.2015.04.07.

Abstract

BACKGROUND

The main aim is to evaluate prolonged safety and efficacy of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd.) sirolimus-eluting coronary stent system.

METHODS

It was a single center, non randomized, retrospective registry. Out of total 530 patients involved in the INDOLIMUS Registry, follow-up of 523 patients were obtained at 1-year The primary end-point of this was major adverse cardiac events, which is a composite of cardiac death, target lesion revascularization, target vessel revascularization, myocardial infarction and stent thrombosis, at 1-year follow-up.

RESULTS

Cardiac death, target lesion revascularization and myocardial infarction at 1-year were reported in 19 (3.6%), 2 (0.4%), and 2 (0.4%) patients respectively, while stent thrombosis was reported in 1 (0.2%) patient. The resultant major adverse cardiac events at 1-year were reported to be 24 (4.5%).

CONCLUSIONS

The lower incidence of MACE in uncontrolled and more complex cohorts at 1-year follow-up clearly depicts the prolonged safety and efficacy of the Indolimus sirolimus-eluting stent (SES) system.

摘要

背景

主要目的是评估Indolimus(萨哈扬南德医疗技术有限公司)西罗莫司洗脱冠状动脉支架系统的长期安全性和有效性。

方法

这是一项单中心、非随机、回顾性注册研究。在INDOLIMUS注册研究纳入的530例患者中,对523例患者进行了1年的随访。其主要终点是主要不良心脏事件,即在1年随访时,它是心脏死亡、靶病变血运重建、靶血管血运重建、心肌梗死和支架血栓形成的综合指标。

结果

1年时分别有19例(3.6%)、2例(0.4%)和2例(0.4%)患者发生心脏死亡、靶病变血运重建和心肌梗死,而有1例(0.2%)患者发生支架血栓形成。1年时报告的主要不良心脏事件为24例(4.5%)。

结论

在1年随访时,未控制的更复杂队列中主要不良心脏事件发生率较低,清楚地表明了Indolimus西罗莫司洗脱支架(SES)系统的长期安全性和有效性。

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