Clinical trial NCT00911976: Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions
Official title: Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Stenting Of Saphenous Vein Grafts Xience V Angiographic Study (SOS-Xience V)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Bypass
Atherosclerosis
Keywords: Coronary artery bypass
Stents
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Restenosis
Everolimus
Saphenous vein grafts
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2009-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary saphenous vein bypass graft lesions.

Detailed description: Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-stent restenosis. Although drug-eluting stents (DES) appear promising, there are limited and conflicting data on their efficacy and safety in SVGs. Our group recently completed and reported the results of the SOS (Stenting Of Saphenous vein grafts) trial that compared a paclitaxel-eluting stent with a similar BMS. There is currently no data on the use of the second generation DES in these challenging lesions. The SOS-Xience V study will examine the effects of the Xience V everolimus-eluting stent in SVG lesions.

The specific aim of SOS-Xience V is to examine the 12-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of \> 50% of the minimum lumen diameter of the target segment) after implantation of the Xience V stent in SVG lesions.

The Xience V stent will be implanted in 40 consecutive patients who need stenting of a SVG lesion. Patients will undergo repeat follow-up angiography and intravascular ultrasonography at 12 months and will be followed clinically for 12 months to determine:

1. the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography (primary study endpoint), and
2. intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography, and (b) 12-month incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) (secondary study endpoints), and (c) percent stent strut coverage by optical coherence tomography

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.5 and 4.5 mm in diameter, is ≤ 22 mm in length, and can be treated with implantation of a single stent
3. Use of an embolic protection device during the SVG intervention
4. Able and willing to return for angiographic follow-up after 12 months
5. Agree to participate and provide informed consent

Exclusion Criteria:

1. Use of stents other than the Xience V stent
2. Planned non-cardiac surgery within the following 12 months
3. Presentation with an ST-segment elevation acute myocardial infarction
4. Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
5. Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
6. Hemorrhagic diatheses, or refusal to receive blood transfusions
7. Current treatment with warfarin
8. Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
9. Coexisting conditions that limit life expectancy to less than 12 months
10. Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
11. Patients allergic to contrast material that can not be adequately premedicated
12. History of an allergic reaction or significant sensitivity to everolimus
13. Documented left ventricular ejection fraction (LVEF) \< 25% at most recent evaluation

Primary outcomes:
measure: the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography
timeFrame: 12 months
Secondary outcomes:
measure: intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography
timeFrame: 12 months
measure: incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization)
timeFrame: 12 months
measure: Percent stent strut coverage by optical coherence tomography
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Healthcare System
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil S Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Texas Veterans Healthcare System
name: Subhash Banerjee, MD
role: STUDY_DIRECTOR
References:
citation: Papayannis AC, Michael TT, Yangirova D, Abdel-Karim AR, Kohlhaas J, Mahmood A, Addo T, Haagen D, Makke L, Roesle M, Rangan B, Banerjee S, Brilakis ES. Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions. J Invasive Cardiol. 2012 Aug;24(8):390-4.