Clinical trial NCT04496648: Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris
Official title: The Danish Randomized Sham-Controlled Study of Invasive Versus Medical Treatment for Stable Angina Pectoris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Stable Angina
Ischemic Heart Disease
Keywords: Atherosclerosis
Fractional flow reserve
Optimal medical therapy
Antianginal
Percutaneous Coronary Intervention
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized patient-blind sham-controlled trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: Combined endpoint of strategy success
timeFrame: 3 months
Secondary outcomes:
measure: Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction
timeFrame: 3 months
measure: Number of conversions to PCI for procedural complication (sham-PCI group)
timeFrame: 3 months
measure: Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Number of patients with clinically driven coronary revascularization
timeFrame: 3 months
measure: Change in CCS class
timeFrame: 3 months
measure: Use of antianginal agents
timeFrame: 3 months
measure: Quality of life score
timeFrame: 3 months
measure: Change in angina-specific quality of life
timeFrame: 3 months
measure: Primary composite endpoint in the modified intention-to-treat population
timeFrame: 3 months
measure: Change in CCS class in the modified intention-to-treat population
timeFrame: 3 months
measure: Change in Seattle Angina Questionnaire 7 score in the modified intention-to-treat population
timeFrame: 3 months
measure: Change in generic quality of life (EQ-5D-5L) in the modified intention-to-treat population
timeFrame: 3 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte University Hospital
state: Copenhagen
Study officials:
affiliation: Zealand Unviersity Hospital
name: Ole Havndrup
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Ole Ahlehoff
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital Skejby
name: Ashkan Eftekhari
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Martin Kirk
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Rikke Sørensen
role: PRINCIPAL_INVESTIGATOR
References: