Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)
Beth Israel Deaconess Medical Center
Summary
Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized. The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.
Description
Invasive physiological assessment via both resting and hyperemic indices has been shown to correlate with clinical outcomes in multiple controlled clinical trials. The traditional approach for the use of physiologic assessment has been in the context of angiographic intermediate lesions, defined as a stenosis between 40-70% stenosis by visual assessment, however it is plausible it could also be used in the context of coronary artery stenosis deemed severe (\>70%) by visual assessment given the clear limitations to an angiography approach alone. A subgroup analysis of the Fractional Flow Reserv…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>/= 18 years * Patient provides written informed consent * Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI)) * Scheduled for clinically indicated cardiac catheterization * At least one lesion with angiographic severity visually estimated to be \>/= 70% diameter stenosis that is deemed suitable for PCI * The operator plans to perform PCI on an ad hoc or planned basis * The target lesion is not planned for assessment by…
Interventions
- Diagnostic TestNon-hyperemic pressure ratio assessment pre and post PCI
Pre and post PCI invasive physiologic assessment
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts