Percutaneous Coronary Intervention Versus Medical Treatment for Stable Angina Pectoris

Not Applicable

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

• Registration Number: NCT04496648
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-06-15
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Study First Posted: 2020-08-03
• Last Update Posted: 2020-08-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Combined endpoint of strategy success	3 months	Number of patients without angina (freedom from angina) and without hospital admission for intolerable stable angina pectoris, unstable angina pectoris, or acute myocardial infarction

Secondary Outcome Measures

Name	Time	Method
Number of conversions to PCI for procedural complication (sham-PCI group)	3 months	see above
Number of patients with hospital admission for intolerable stable angina, unstable angina pectoris, or acute myocardial infarction	3 months	see above
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	3 months	see above
Number of patients with clinically driven coronary revascularization	3 months	see above
Change in CCS class	3 months	see above
Use of antianginal agents	3 months	0, 1, 2, or 3 agents
Quality of life score	3 months	5- level EQ-5D (EQ-5D-5L) questionnaire. Each dimension will be scored from 0-5 where a higher score means a better outcome. .
Number of all-cause death, any myocardial infarction, stroke, major bleeding, and severe drug reaction	3 months	see above
Change in angina-specific quality of life	3 months	Seattle Angina Questionnaire 7. Values will range from 0-100 where higher score means better outcome.
Primary composite endpoint in the modified intention-to-treat population	3 months	The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding.
Change in CCS class in the modified intention-to-treat population	3 months	The modified intention-to-treat population is comprised of patients who underwent the study procedure and follow-up without overt or formal unblinding.
Change in Seattle Angina Questionnaire 7 score in the modified intention-to-treat population	3 months	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.
Change in generic quality of life (EQ-5D-5L) in the modified intention-to-treat population	3 months	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.

Trial Locations

Locations (1)

Gentofte University Hospital; 🇩🇰 Gentofte, Copenhagen, Denmark