Purpose
Coronary artery disease (CAD) is a major cause of mortality and morbidity (1) and the identification of CAD patients at high risk of adverse events is crucial.
Several non-invasive stress tests (NIST) are commonly used as gatekeepers to invasive coronary angiography (ICA).
However,
the diagnostic yield of the invasive procedure is still low (2,
3).
Coronary computed tomography angiography (cCTA) has been recently introduced as an alternative imaging modality to rule out CAD (4,
5) with low radiation exposure (6) and the potential for improving...
Methods and Materials
Overall study design. The PERFECTION study is a longitudinal,
prospective and consecutive cohort study to compare the feasibility and accuracy of FFRCT versus stress-CTP for the diagnosis of functionally significant CAD.
The target populations are symptomatic subjects with suspected CAD and no contra-indications to FFRCT and stress CTP who are referred for non-emergent,
clinically indicated ICA.
Exclusion criteria will include: a) low pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score (22); b) prior clinically documented myocardial infarction; c) previous history of...
Results
EFFICACY ANALYSIS,
SAMPLE SIZE DETERMINATION AND STATISTICAL ANALYSIS
Efficacy analysis.
The primary end point is to compare the feasibility and diagnostic accuracy of FFRCT versus static and dynamic stress-CTP.
The secondary end points are : a) diagnostic accuracy of coronary artery imaging at rest cCTA datasets versus coronary artery imaging at stress CTP datasets for diagnosis of obstructive CAD using ICA as reference standard; b) diagnostic accuracy between static CTP versus dynamic CTP for the detection of functionally significant CAD using ICA plus invasive FFR...
Conclusion
In conclusion,
the PERFECTION study will compare FFRct and stress CTP with the aim of providing information about which is the more effective technology for the diagnosis of functionally significant CAD.
The first patient will be enrolled in September 2015 and patient enrollment will be completed by the end of September 2017.
References
1. Lucas FL,
De Lorenzo MA,
Siewers AE,
et al.
Temporal trends in the utilization of diagnostic testing and treatments for cardiovascular disease in the United States,
1993-2001.
Circulation.
2006;24;113:374-9.
2. Patel MR,
Peterson ED,
Dai D,
et al.
Low diagnostic yield of elective coronary angiography.
N Engl J Med.
2010; 11;362:886-95.
3. Patel MR,
Dai D,
Hernandez AF,
et al.
Prevalence and predictors of non obstructive coronary artery disease identified with coronary angiography in contemporary clinical practice.
Am Heart J.
2014;167:846-52.
Pontone G,
Andreini...