Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris

Conditions
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Coronary Heart Disease, Stable Angina, Ischemic Heart Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Procedure: Sham-percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized patient-blind sham-controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous Coronary Intervention<br>Conventional PCI and optimal medical therapy | Procedure: Percutaneous Coronary Intervention<br>* Percutaneous coronary intervention with drug-eluting stents and modern techniques<br>* Other names: PCI;|
| Placebo Comparator: Sham-percutaneous coronary intervention<br>Sham-PCI and optimal medical therapy | Procedure: Sham-percutaneous coronary intervention<br>* 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.<br>* Other names: sham-PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction | see above | 3 months | 
| Number of conversions to PCI for procedural complication (sham-PCI group) | see above | 3 months | 
| Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction | see above | 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 | 3 months | 
| Number of patients with clinically driven coronary revascularization | see above | 3 months | 
| Change in CCS class | see above | 3 months | 
| Use of antianginal agents | 0, 1, 2, or 3 agents | 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. . | 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. | 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. | 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. | 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. | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Fractional flow reserve, Optimal medical therapy, Antianginal, Percutaneous Coronary Intervention