Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents

Study Overview
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Brief Summary
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Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up. Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.

Detailed Description
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This is a prospective, multicenter, randomized study assessing the efficacy of stenting moderate SVG lesions (30% to 60% by visual estimation) with paclitaxel-eluting stents in the prevention of SVG atherosclerosis progression and cardiac events at follow-up. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. Following this procedure, all patients will have follow-up visits by telephone or clinic at 30 days, 180 days, 1 year, and yearly until the common study end date. The duration of the study will be approximately 4 years with a minimun of 2-year follow-up.

Official Title
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Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents as a New Approach to MainTaining VeIn Graft Patency and Reducing Cardiac Events

Conditions
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Coronary Artery Bypass Grafting

Intervention / Treatment
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* Device: Paclitaxel eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical indication for cardiac catheterization and SVG angiography Presence of at least one SVG lesion of 30% to 60% diameter stenoses, by visual estimation, which is not the culprit lesion* responsible for the clinical syndrome of the patient *If the target lesion is located in the same SVG than the culprit lesion (if present) it has to be at least 4 cm far from the stented segment) Written informed consent Exclusion Criteria: Patient < 18 years old Ejection fraction < 30% Renal insufficiency with creatinine > 200 μmol/l Presence of more than 2 moderate SVG stenoses in a single SVG or significant diffuse SVG disease defined as disease covering more than half of the length of the SVG Presence of more than 2 SVGs with moderate SVG stenoses Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure (culprit lesions will be treated before patient randomization) Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure SVG lesion located at the distal anastomosis SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium) Lesion length >25 mm SVGs ≤ 3 years ago Cardiogenic shock Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year Pregnancy Contraindication to aspirin and/or thienopyridine/ticagrelor treatment Allergy to paclitaxel Any disease with a limiting life-expectancy (less than 2 years) Need for chronic anticoagulation treatment Definite presence or high suspicion of thrombus or ulceration in the target lesion Target lesion located in the same SVG as the culprit lesion (if present) and distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion < 4 cm Vein graft diameter < 2.5 mm

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI-stenting<br>Stenting the moderate SVG lesion with the paclitaxel stent | Device: Paclitaxel eluting stent<br>* Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment<br>|
| No Intervention: Standard medical treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization related to the target SVG over the duration of follow-up. |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up. |  | 60 months | 
| 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome. |  | 60 months | 
| 3-Total medical costs (at index hospitalization and at follow-up). |  | 60 months | 
| 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented. |  | 60 months | 
| 5-Severe (>60%) SVG lesions or SVG occlusion at the target SVG at 2-year follow-up as determined by 3D computed-tomography. |  | 60 months | 
| 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up. |  | 60 months | 
| 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria. |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Grafting, Drug Eluting Stent, Saphenous Vein Graft