Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris (DANANGINA)

Herlev and Gentofte Hospital

Status: Unknown

Conditions: Ischemic Heart Disease; Coronary Heart Disease; Stable Angina

Treatments: Procedure: Sham-percutaneous coronary intervention; Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04496648

H-18009651

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Age 18-85 years
• Patients with stable angina pectoris undergoing elective coronary angiography
• Canadian Cardiovascular Society (CCS) class 2 or 3
• Informed consent
• Lesions in one or more coronary vessels with a diameter >2.5 mm with FFR-values ≤0.80, and suitable for complete revascularization with PCI.

Exclusion criteria

• Contraindication to PCI or dual antiplatelet therapy (DAPT)
• Use of or indication for oral anticoagulants (OAC) or novel oral anticoagulants (NOAC)
• Use of clopidogrel
• Life expectancy of less than 2 years
• Severe valvular disease
• Severe comorbidity
• Acute coronary event within the past 12 months
• Left ventricular ejection fraction ≤35%.
• Renal function with estimated glomerular filtration rate (eGFR) <30 mL/min
• Pregnant or nursing
• Severe coronary artery disease (left main stenosis, 3-vessel disease, proximal left anterior descending stenosis, chronic total occlusion of major vessel)
• Coronary disease where complete revascularization by PCI is considered difficult or impossible.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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450 participants in 2 patient groups, including a placebo group

Percutaneous Coronary Intervention

Active Comparator group

Description:

Conventional PCI and optimal medical therapy

Treatment:

Procedure: Percutaneous Coronary Intervention

Sham-percutaneous coronary intervention

Placebo Comparator group

Description:

Sham-PCI and optimal medical therapy

Treatment:

Procedure: Sham-percutaneous coronary intervention