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Published on: January 16, 2019
Intravascular ultrasound guidance for complex high-risk indicated procedures in underrepresented patient populations
Ernest Spitzer1, Ximena S Paredes2, J Dawn Abbott3
1European Cardiovascular Research Institute, Rotterdam, the Netherlands; Cardialysis, Rotterdam, the Netherlands.
Insights
Intravascular ultrasound (IVUS) guidance improves percutaneous coronary intervention (PCI) outcomes in complex coronary lesions for minority populations. This registry study assessed IVUS-guided PCI safety and efficacy in underrepresented patients with high-risk procedures.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Intravascular ultrasound (IVUS) is recommended for percutaneous coronary intervention (PCI) in complex coronary lesions.
- Complex coronary anatomy affects up to one-third of patients, correlating with poorer outcomes.
- Limited data exists on lesion characteristics and outcomes in minority patient groups.
Purpose of the Study:
- To evaluate the safety and efficacy of IVUS-guided PCI in underrepresented minority populations undergoing complex high-risk procedures.
- To assess procedural and clinical outcomes in this specific patient demographic.
Main Methods:
- Prospective, observational, multicenter, single-arm study (IVUS CHIP UPP Registry).
- Included ~1010 subjects identifying within a demographic minority undergoing complex high-risk PCI.
- Defined optimal stenting criteria and assessed target-vessel failure at 1 year.
Main Results:
- The study focused on safety and efficacy of IVUS-guided PCI in a minority population.
- Specific criteria for optimal stenting were applied.
- Primary endpoint was target-vessel failure at 1 year, with secondary procedural and imaging endpoints.
Conclusions:
- The IVUS CHIP UPP Registry is the first prospective study of its kind.
- It investigates IVUS-guided PCI outcomes in complex coronary lesions among US minority populations.
- Provides crucial data on managing complex coronary artery disease in underrepresented groups.
Background:
Intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) of complex coronary lesions is currently recommended by international guidelines. Complex coronary anatomy is observed in up to one third of the patients undergoing coronary interventions and is associated with worse clinical outcomes. Data on lesion characteristics and outcomes are scarce in census-defined minority groups.
Methods/Design:
The Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures in Underrepresented Patient Populations (UPP) Registry is a prospective, observational, multicenter, single-arm study describing the safety and efficacy of IVUS-guided PCI in approximately 1010 subjects who self-identify within a demographic minority and undergo complex high-risk procedures. Criteria for optimal stenting include final minimal stent area (MSA) >5 mm2 or MSA >90 % of the distal reference lumen, plaque burden <50 % within 5 mm proximal or distal to stent edges, and absence of edge dissections involving the media and > 3 mm in length. The primary endpoint of target-vessel failure is a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization at 1 year. Secondary endpoints include the individual components of the primary end point as well as procedural and imaging endpoints.
Summary:
The IVUS CHIP UPP Registry is the first prospective investigation of procedural and clinical outcomes related to an IVUS-guided PCI for management of complex coronary lesions among minority patient populations in the United States.
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