Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris

Coronary Heart Disease Clinical Trial

— DANANGINA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496648
• Other study ID #: H-18009651
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2020
• Source: Herlev and Gentofte Hospital
• Contact: Sune Ammentorp Haahr-Pedersen, MD
• Phone: +45 38672267
• Email: sunped01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stable Angina

Intervention

Procedure:
• Percutaneous Coronary Intervention
Percutaneous coronary intervention with drug-eluting stents and modern techniques
• Sham-percutaneous coronary intervention
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.

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Gentofte	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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