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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
450
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Sham-PCI procedure for at least 15 minutes that includes shifting the C-arm, reinserting the FFR-wire in the catheter and inflating the device.
Gentofte University Hospital
Gentofte Municipality, Copenhagen, Denmark
RECRUITINGCombined endpoint of strategy success
Number of patients without angina (freedom from angina) and without hospital admission for intolerable stable angina pectoris, unstable angina pectoris, or acute myocardial infarction
Time frame: 3 months
Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction
see above
Time frame: 3 months
Number of conversions to PCI for procedural complication (sham-PCI group)
see above
Time frame: 3 months
Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
see above
Time frame: 3 months
Number of patients in CCS class 1, 2, and 3, respectively, without hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
see above
Time frame: 3 months
Number of patients with clinically driven coronary revascularization
see above
Time frame: 3 months
Change in CCS class
see above
Time frame: 3 months
Use of antianginal agents
0, 1, 2, or 3 agents
Time frame: 3 months
Quality of life score
5- level EQ-5D (EQ-5D-5L) questionnaire. Each dimension will be scored from 0-5 where a higher score means a better outcome. .
Time frame: 3 months
Change in angina-specific quality of life
Seattle Angina Questionnaire 7. Values will range from 0-100 where higher score means better outcome.
Time frame: 3 months
Primary composite endpoint in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding.
Time frame: 3 months
Change in CCS class in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding.
Time frame: 3 months
Change in Seattle Angina Questionnaire 7 score in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding. Values will range from 0-100 where higher score means better outcome.
Time frame: 3 months
Change in generic quality of life (EQ-5D-5L) in the modified intention-to-treat population
The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding. Each dimension will be scored from 0-5 where a higher score means a better outcome.
Time frame: 3 months
Niels Thue Olsen, MD, PhD
CONTACT
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