Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)

Study Overview
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Brief Summary
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During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein bypasses themselves develop blockages over time, a process termed saphenous vein graft disease. By lowering cholesterol levels in the blood, statin medications are used after surgery to prevent the development of atherosclerotic blockages in the vein bypasses. Recently, higher doses of statin medications have been introduced, with some studies showing that they are more effective than traditional doses when used in heart attack patients. Furthermore, laboratory tests have shown that higher doses of statin medications can slow the development of atherosclerosis. Despite these benefits, very little is known regarding the use of high-dose statin therapy after bypass surgery in humans. The goal of this study will be to see if high-dose statin therapy will prevent the development of vein graft occlusion during the first year after bypass surgery. Patients will be randomized to receive either high-dose statin therapy or conventional moderate-dose statin therapy starting within 4 days of surgery and continuing for the duration of one year after the operation. The statin medication will be given in capsule form. During the course of this study, neither the patient nor the health care team will know which treatment each patient is receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will be performed to evaluate the patency of the vein bypasses.

Detailed Description
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The current clinical guidelines recommend treatment to achieve LDL levels <100 mg/dL after surgical coronary revascularization. However, recent studies have illustrated that even more intensive lipid reduction with high-dose statins can further improve cardiovascular outcomes. Targeting LDL levels to 70 mg/dL after CABG with intensive statin therapy may prevent the process of postoperative saphenous vein graft disease and lead to improved graft patency. Therefore, in the ACTIVE Trial, we will conduct a randomized controlled trial comparing high-dose (80 mg atorvastatin) to moderate-dose (10 mg atorvastatin)statin therapy in patients undergoing CABG with saphenous vein grafts. The effect of aggressive cholesterol therapy on the process of vein graft disease will be examined with computed tomography (CT) coronary angiography one year after CABG. This study will address the subject of postoperative high-dose statin therapy and help determine the optimal lipid-lowering strategy following CABG.

Official Title
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Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?

Conditions
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Saphenous Vein Graft Disease

Intervention / Treatment
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* Drug: Atorvastatin 80 mg daily
* Drug: Atorvastatin 10 mg daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing first-time CABG with at least 1 saphenous vein graft Exclusion Criteria: Redo-CABG Statin allergy Severe renal dysfunction Severe liver disease

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose statin therapy<br>Atorvastatin 80 mg daily | Drug: Atorvastatin 80 mg daily<br>* Atorvastatin 80 mg daily for 1 year<br>|
| Active Comparator: Moderate-dose statin therapy<br>Atorvastatin 10 mg daily | Drug: Atorvastatin 10 mg daily<br>* Atorvastatin 10 mg daily for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year | Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG | 1 year after CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography | Vein graft stenosis 1 year after CABG based on CT coronary angiography | Within 1 year after CABG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statin,, CABG,, saphenous vein graft,, graft occlusion,, lipids