Rajasekhar Durgaprasad, Vanajakshamma Velam, Vidyasagar Akula, Ranganayakulu Kummaraganti Paramatma, Babu Mannuva Boochi, Sivasankara Chakali, Kothari Shivani, Thakkar Ashok
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.
Cardiovasc Diagn Ther. 2015 Aug;5(4):249-53. doi: 10.3978/j.issn.2223-3652.2015.04.07.
The main aim is to evaluate prolonged safety and efficacy of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd.) sirolimus-eluting coronary stent system.
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.
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%).
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.
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。
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。
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%）。
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。
