The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.
Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia. FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed. Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions. The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
221
final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.
IUCPQ - Laval Hospital
Québec, Quebec, Canada
Rate of Target Vessel Failure
as the composite of cardiac death, lesion-related MI and target vessel revascularization
Time frame: within 18 months after index PCI;
Rate of angina-related events
defined as hospitalization for unstable angina and unsolicited medical visits for angina
Time frame: within 18 months after index PCI;
Final post-PCI pressure ratio values according to lesion location and intervened vessels
In the Physiology group, final pressure ratio (Pd/Pa) values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Time frame: Post-randomization after stent implantation (< 1 hour)
Final post-PCI FFR values according to lesion location and intervened vessels
In the Physiology group, final FFR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Time frame: Post-randomization after stent implantation (< 1 hour)
Final post-PCI dPR values according to lesion location and intervened vessels
In the Physiology group, final dPR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Time frame: Post-randomization after stent implantation (< 1 hour)
Final post-PCI physiology pullback curves according to lesion location and intervened vessels
In the Physiology group, final physiology pullback curves will be collected immediately after randomization, and if further intervention is performed, before completing the intervention if possible. Physiology pullback refers to either hyperemic or non-hyperemic pullback.
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Time frame: Post-randomization after stent implantation (< 1 hour)
Rates of unstable angina requiring hospitalization or unsolicited medical visits
Time frame: within 18 months of index procedure
Rates of individual components of MACE
including all-cause mortality, MI, TVR and any revascularization
Time frame: within 18 months of index procedure