Coronary Heart Disease Clinical Trial
Official title:
The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris
Patients with ischemic heart disease and symptoms due to lack of oxygen to the heart on exertion (stable angina pectoris) are usually treated by either percutaneous coronary intervention (PCI) or optimal medical therapy (OMT) alone. In patients with mild to moderate coronary artery disease the prognostic impact of PCI is probably limited. Furthermore it is unclear which treatment is superior in terms of relieving symptoms (PCI or OMT). In this trial, patients with mild to moderate coronary artery disease will be randomized to PCI or sham-PCI. All patients will undergo optimal medical therapy. It is hypothesized that PCI is superior to sham-PCI in patients with stable angina pectoris undergoing optimal medical therapy in terms of symptom-relief.
Ischemic heart disease (IHD) is a major cause of death and disability worldwide. Patients
with ischemic heart disease and symptoms due to lack of oxygen to the heart on exertion
(stable angina pectoris) are usually treated by either percutaneous coronary intervention
(PCI) or optimal medical therapy (OMT) alone. In patients with mild to moderate coronary
artery disease the prognostic impact of PCI is probably limited. Furthermore it is unclear
which treatment is superior in terms of relieving symptoms (PCI or OMT). Both treatments are
effective in terms of reducing symptoms, but come with potential side effects.
PCI has in previous trials failed to show superiority compared to medical therapy in patients
with stable angina pectoris. However, many visually significant lesions do not limit the
blood flow significantly to the heart, and stenting such a lesion only exposes the patient to
the risk of side effects of intervention. In recent years it has therefore become
guideline-recommended practice to perform physiological test to evaluate a potential
stenosis. During an angiography this is most often done using fractional flow reserve (FFR).
This study tests the optimal strategy for treatment of angina-symptoms in patients with
stable pectoris. PCI is performed with modern stent designs and use of intravascular
functional testing (FFR-guided PCI) and compared to sham-PCI.
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