A Jabir, Malviya Amit, Thomas Joby, S Vijaykumar, Mandalay Ashishkumar, Joseph Jo, Mathew Rony
Cardiology, Lisie Hospital, Kochi, IND.
Cardiology, North Eastern Indira Gandhi Regional Institute of Health And Medical Sciences, Shillong, IND.
Cureus. 2021 Sep 16;13(9):e18027. doi: 10.7759/cureus.18027. eCollection 2021 Sep.
Background Bifurcation coronary stenting (BCS) has unique therapeutic challenges. Several BCS strategies are prescribed for treatment, with conflicting data, and which is the best strategy for optimal short- and long-term outcomes remains a matter of debate. There is no systematic data from an Indian perspective in regard to patterns of BCS and its outcomes. Methods and analysis The Indian Bifurcation Stenting (IBIS) registry is a prospective, nationwide, endpoint-driven, investigator-initiated, multi-center, observational registry to compare the different bifurcation stent strategies, the effect of adjuvant techniques, and bifurcation anatomical differences in predicting short- and long-term clinical outcomes of bifurcation coronary interventions in India. A total of 1,000 patients from 20 clinical sites across the country will be enrolled in this study from September 2020 to August 2023. The primary endpoint will be the composite endpoint of major adverse cardiac events including cardiac death, target lesion myocardial infarction (MI), and ischemia-driven target lesion revascularization at the end of two years. The secondary endpoints include all causes of death, MI, target vessel revascularization, in-stent restenosis, stroke, and predefined procedural parameters. The safety endpoint is the occurrence of definite or probable stent thrombosis. Conclusion The aim of this prospective observational registry is to assess the practice patterns and clinical outcomes of patients undergoing coronary bifurcation lesion angioplasty in India. This will be extremely useful to provide an evidence-based insight as well as guidance to bifurcation angioplasty in India.
背景 冠状动脉分叉病变支架置入术（BCS）具有独特的治疗挑战。目前针对该疾病规定了几种治疗策略，但相关数据存在冲突，哪种策略能实现最佳的短期和长期疗效仍是一个有争议的问题。从印度的角度来看，目前尚无关于BCS模式及其结果的系统性数据。
方法与分析 印度分叉病变支架置入术（IBIS）注册研究是一项前瞻性、全国性、终点驱动、研究者发起的多中心观察性注册研究，旨在比较不同的分叉病变支架策略、辅助技术的效果以及分叉病变解剖结构差异对印度冠状动脉分叉病变介入治疗短期和长期临床结果的预测作用。2020年9月至2023年8月期间，将从全国20个临床地点招募1000名患者参与本研究。主要终点为两年末包括心源性死亡、靶病变心肌梗死（MI）和缺血驱动的靶病变血运重建在内的主要不良心脏事件复合终点。次要终点包括各种原因导致的死亡、MI、靶血管血运重建、支架内再狭窄、中风以及预设的手术参数。安全终点为明确或可能的支架血栓形成事件。
结论 这项前瞻性观察性注册研究的目的是评估印度接受冠状动脉分叉病变血管成形术患者的治疗模式和临床结果。这对于为印度的分叉病变血管成形术提供基于证据的见解和指导将极为有用。
