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Published on: July 25, 2019
Rationale, Design, and Implications of Bifurcation Coronary Stenting: Insight from the Indian Bifurcation Stenting
Jabir A1, Amit Malviya2, Joby Thomas3
1Cardiology, Lisie Hospital, Kochi, IND.
Insights
The Indian Bifurcation Stenting (IBIS) registry is evaluating coronary artery stenting strategies in India. This study aims to provide evidence-based guidance for optimal patient outcomes in bifurcation interventions.
Area of Science:
- Cardiology
- Interventional Cardiology
- Public Health
Background:
- Bifurcation coronary stenting (BCS) presents unique challenges with debated optimal strategies.
- Existing data lacks a specific Indian perspective on BCS patterns and outcomes.
Purpose of the Study:
- To prospectively assess practice patterns and clinical outcomes of BCS in India.
- To compare different bifurcation stenting strategies and adjuvant techniques.
- To identify factors influencing short- and long-term outcomes of coronary bifurcation interventions.
Main Methods:
- Prospective, nationwide, multi-center, observational registry (Indian Bifurcation Stenting - IBIS).
- Enrollment of 1,000 patients across 20 clinical sites from September 2020 to August 2023.
- Primary endpoint: Major adverse cardiac events at two years; secondary endpoints include death, MI, TVR, ISR, stroke, and stent thrombosis.
Main Results:
- Data collection ongoing; primary and secondary endpoints to be analyzed at study completion.
- Focus on major adverse cardiac events (cardiac death, MI, ischemia-driven target lesion revascularization).
- Safety endpoint: incidence of definite or probable stent thrombosis.
Conclusions:
- The IBIS registry will provide crucial insights into Indian BCS practices.
- Findings will guide evidence-based recommendations for coronary bifurcation angioplasty in India.
- Aims to improve patient care and long-term outcomes for complex coronary interventions.
Abstract:
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.
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