Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Bypass Grafting
• Intervention / Treatment: Device: Paclitaxel eluting stent

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical indication for cardiac catheterization and SVG angiography

2. 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)

3. Written informed consent

Exclusion Criteria:

1. Patient < 18 years old
2. Ejection fraction < 30%
3. Renal insufficiency with creatinine > 200 μmol/l
4. 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
5. Presence of more than 2 SVGs with moderate SVG stenoses
6. 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)
7. Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
8. SVG lesion located at the distal anastomosis
9. SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium)
10. Lesion length >25 mm
11. SVGs ≤ 3 years ago
12. Cardiogenic shock
13. Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
14. Pregnancy
15. Contraindication to aspirin and/or thienopyridine/ticagrelor treatment
16. Allergy to paclitaxel
17. Any disease with a limiting life-expectancy (less than 2 years)
18. Need for chronic anticoagulation treatment
19. Definite presence or high suspicion of thrombus or ulceration in the target lesion
20. 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
21. Vein graft diameter < 2.5 mm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Collaborators: Canadian Institutes of Health Research (CIHR); Boston Scientific Corporation

Publications and helpful links

General Publications

• Rodes-Cabau J, Jolly SS, Cairns J, Mansour S, L'Allier PL, Teefy PJ, Graham JJ, Le May MR, Cantor WJ, Wood D, Balasubramanian K, DeLarochelliere R, Dzavik V; VELETI II Investigators (Sealing Moderate Coronary Saphenous Vein Graft Lesions With Paclitaxel-Eluting Stents). Sealing Intermediate Nonobstructive Coronary Saphenous Vein Graft Lesions With Drug-Eluting Stents as a New Approach to Reducing Cardiac Events: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2016 Nov;9(11):e004336. doi: 10.1161/CIRCINTERVENTIONS.116.004336.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (Estimate): October 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Drug Eluting Stent; Coronary Artery Bypass Grafting; Saphenous Vein Graft
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: VELETI II