Rajasekhar D, Vanajakshamma V, Shashank C, Srinivasakumar M L, Sivasankara C
Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, 517507, India.
Catheter Cardiovasc Interv. 2016 Sep;88(3):E93-8. doi: 10.1002/ccd.25246. Epub 2014 Jan 7.
This INDOLIMUS Registry sought to evaluate the safety and efficacy of the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent for the treatment of coronary artery disease across a wide range of patients treated in routine clinical practice, including those with high-risk characteristics and complex lesions.
First-generation drug-eluting stents utilize nonbiodegradable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events in an unselected patient population.
All 530 consecutive unselected patients (415 males and 115 females) included who underwent percutaneous coronary intervention at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India between August 2012 and March 2013, with an in-hospital, at 30-days and at 6-months follow-up. Retrospective analysis of those data had been done.
A total of 617 lesions were treated in 530 enrolled patients (mean age 54.9 ± 10.8 years) with average stent length of 18.8 ± 6.0 mm. An average of 1.18 stents was implanted per patient. The patients' characteristics are noted as having 169 (31.9%) patients of diabetics and 215 (40.6%) hypertension. Smoking, alcoholism and tobacco chewing were found in 273 (51.5%), 130 (24.5%) and 17 (3.2%), respectively. The indications for intervention were unstable angina in 77 (14.5%) and previous myocardial infarction in 56 (10.6%) of the patients. Lesions were of type B2 in 264 (42.7%) and type C in 127 (20.6%). Stent delivery was successful in all cases and in-hospital, 30-days and 6-months follow-up of all 530 patients was obtained. The incidence of any major adverse cardiac events at in-hospital, at 30-days and at 6-months were 5 (0.94%), 8 (1.52%), and 18 (3.40%), respectively. Long term follow-up of this registry is ongoing to confirm safety and efficacy profiles.
The relatively low event rate that was observed in INDOLIMUS Registry indicates that the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent can achieve excellent clinical performances in a large group of patients. © 2013 Wiley Periodicals, Inc.
本吲哚莫司注册研究旨在评估可生物降解聚合物涂层的吲哚莫司（Indolimus®）西罗莫司洗脱冠状动脉支架在常规临床实践中治疗的广泛患者群体（包括具有高风险特征和复杂病变的患者）中的安全性和有效性。
第一代药物洗脱支架使用不可生物降解的聚合物涂层，其在动脉壁中的持续存在可能对长期预后产生负面影响。据推测，聚合物的持续存在可能会损害药物洗脱支架的安全性，因此可生物降解的聚合物涂层可能会减少未选择患者群体中的晚期不良事件。
纳入2012年8月至2013年3月在印度蒂鲁伯蒂市斯利那加德瓦拉医学科学研究所接受经皮冠状动脉介入治疗的所有530例连续未选择患者（415例男性和115例女性），并进行住院、30天和6个月随访。对这些数据进行了回顾性分析。
530例入选患者（平均年龄54.9±10.8岁）共治疗617处病变，平均支架长度为18.8±6.0mm。每位患者平均植入1.18枚支架。患者特征显示，糖尿病患者169例（31.9%），高血压患者215例（40.6%）。吸烟、酗酒和嚼烟的患者分别有273例（51.5%）、130例（24.5%）和17例（3.2%）。干预指征为不稳定型心绞痛77例（14.5%），既往心肌梗死56例（10.6%）。病变类型为B2型264例（42.7%），C型127例（20.6%）。所有病例支架置入均成功，对所有530例患者进行了住院、30天和6个月随访。住院、30天和6个月时任何主要不良心脏事件的发生率分别为5例（0.94%）、8例（1.52%）和18例（3.40%）。该注册研究的长期随访正在进行中，以确认安全性和有效性概况。
吲哚莫司注册研究中观察到的相对较低的事件发生率表明，可生物降解聚合物涂层的吲哚莫司（Indolimus®）西罗莫司洗脱冠状动脉支架在大量患者中可实现优异的临床性能。©2013威利期刊公司。
