Quality of Life Clinical Trial
Official title:
Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention
Current guidelines for the diagnosis and management of patients with stable coronary artery disease (CAD) strongly support the performance of non-invasive imaging techniques for the detection of myocardial ischemia prior to revascularization procedures. This recommendation originates from the strong evidence base showing the lack of prognostic benefit from percutaneous coronary interventions (PCI) over optimal medical therapy in patients without verification of myocardial ischemia. On the other hand, it could be demonstrated that patients with functionally significant coronary artery stenoses do benefit from revascularization. Cardiac magnetic resonance imaging (CMR) has emerged to be a diagnostic modality of choice for the detection of myocardial ischemia with high sensitivity and specificity. The investigators therefore designed this prospective and randomized trial to compare a CMR-driven vs. angiography-driven management of patients with stable CAD concerning major cardiac endpoints, futile angiographies and quality of life.
Current guidelines for the diagnosis and management of patients with stable coronary artery
disease (CAD) recommend - besides thorough history and physical examination - proper risk
stratification prior to invasive therapy. The detection or exclusion of moderate to severe
reversible myocardial ischemia is a crucial part of the work-up process which designates the
patients to the high-risk group when ischemia is present. This is of special interest, as
several observational studies have shown that the prognostic benefit from revascularization
depends on the amount of myocardial ischemia. Moreover, patients without ischemia do not seem
to benefit from revascularization over optimal medical therapy. This emphasizes the need for
functional testing prior to therapeutic decisions.
Invasive coronary angiography still is considered to be the "gold-standard" for the diagnosis
of CAD, though it exhibits several limitations and shortcomings. Multiple studies have
documented the significant interobserver variability in the grading of coronary artery
stenosis, as well as the frequent occurrence of under- and overestimation of hemodynamic
relevance. One has to conclude that coronary angiography may provide anatomical information
but is not the modality of choice concerning the detection of myocardial ischemia. Moreover,
there is no study which has randomized patients with stable CAD to either catheterization or
no catheterization yet, so there does not exist high-quality evidence which would support the
performance of a diagnostic coronary angiography in the majority of cases of stable CAD. This
is of special interest, as there is a reported frequency of complications due to diagnostic
coronary angiography of about 1.5%. Nevertheless, coronary angiography remains the most often
performed diagnostic test in this setting, with more than one-half of elective percutaneous
coronary interventions (PCI) done without previous stress-testing.
Adenosine perfusion cardiac magnetic resonance imaging (CMR) is an imaging modality which
provides anatomical and functional information in one single examination. With its ability to
reliably detect reversible myocardial ischemia, it plays an increasing role in the diagnosis
and risk stratification of patients with suspected or known CAD. Though CMR therefore is
highly recommended in the diagnostic work-up in the setting of stable CAD, no study exists
which would have evaluated a CMR driven approach in patient management with regard to the
occurrence of major cardiac events, quality of life and safety endpoints.
Objective of our study is to show that a CMR based conservative or invasive management of
patients with suspected or known CAD is not inferior with regard to major cardiac endpoints
and quality of life in comparison to a - more conventional - coronary angiography based
approach. The investigators assume that a significant number of diagnostic coronary
angiographies and PCIs thus could be spared without decrease in patient safety and comfort.
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