The SOS (Stenting Of Saphenous Vein Grafts) Trial

Arteriosclerosis Clinical Trial

Official title:

The SOS (Stenting Of Saphenous Vein Grafts) Randomized-controlled Trial of a Paclitaxel-eluting Stent vs. a Bare Metal Stent in Saphenous Vein Graft Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247208
• Other study ID #: VISN 17, 10N17
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2005
• Last updated: April 25, 2012
• Start date: May 2005
• Est. completion date: June 2011

Study information

• Verified date: April 2012
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent.

Description:

Introduction: The prevalence of coronary artery bypass graft (CABG) surgery is high in the veteran population. Saphenous veins are used as conduits in the majority of CABG operations. Compared to arterial conduits, saphenous vein grafts (SVGs) have a high rate of failure, requiring percutaneous coronary intervention (PCI) or repeat CABG. Bare metal stents are currently used in the majority of PCI in SVGs because they increase the procedural success rate and decrease restenosis. However, even with the use of bare metal stents, restenosis still occurs in 37-53% of the SVGs, often requiring repeat target vein graft revascularization.

Drug-eluting stents (DES) have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries. Even though, no randomized controlled trials have compared DES with bare stents in SVG interventions, DES are increasingly being used off label in this setting, based on registry data. DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries. We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent (which is identical to the paclitaxel-eluting stent but has no drug coating) in saphenous vein graft lesions.

Hypothesis: Compared to implantation of a bare metal stent, implantation of a similar paclitaxel-eluting stent (Taxus™, Boston Scientific, Nattick, Massachusetts) in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months.

Specific objectives: We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent (Taxus™) in order to determine:

1. whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography (primary study endpoint), and

2. whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization, target vessel failure, overall major adverse cardiac and cerebrovascular events, and intra-stent intimal hyperplasia accumulation, as measured by intravascular ultrasound (secondary endpoints).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least one 50-99% de-novo or restenotic lesion in a saphenous vein graft that is between 2.5 and 4.0 mm in diameter, requiring percutaneous coronary intervention according to the opinion of the attending cardiologist

• willing to return for repeat coronary angiography after 12 months

• able to give informed consent

Exclusion Criteria:

• previous or planned use of intravascular brachytherapy in the target vessel

• a left ventricular ejection fraction of less than 25 percent

• hemorrhagic diatheses

• contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainless steel

• a history of anaphylaxis in response to iodinated contrast medium

• use of paclitaxel within 12 months before study entry or current use of colchicine

• a serum creatinine level of more than 2.0 mg per deciliter (177 µmol per liter)

• a leukocyte count of less than 3500 per cubic millimeter, or a platelet count of less than 100,000 per cubic millimeter

• a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy

• coexisting conditions that limit life expectancy to less than 24 months or that could affect a patient's compliance with the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Artery Bypass

Intervention

Device:
• Taxus polymer-based paclitaxel-eluting stent
Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
• Express 2 bare metal stent
Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.

Locations

Country	Name	City	State
Greece	Onassis Cardiac Surgery Center	Athens
United States	VA North Texas Health Care System	Dallas	Texas
United States	Michael E. Debakey VA Medical Center	Houston	Texas
United States	VA Iowa City Healthcare system	Iowa City	Iowa
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (7)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System	Clark R. Gregg Fund, Harris Methodist Foundation, Michael Debakey Veterans Affairs Medical Center, Onassis Cardiac Surgery Centre, Southern Arizona VA Health Care System, University of Arkansas, VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Greece, 

References & Publications (6)

Badhey N, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Addo TA, Haagen D, Abdel-Karim AR, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger PB, Banerjee S, Brilakis ES. Contemporary use of embolic protection — View Citation

Brilakis ES, Lichtenwalter C, Abdel-karim AR, de Lemos JA, Obel O, Addo T, Roesle M, Haagen D, Rangan BV, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S. Continued benefit from paclitaxel-eluti — View Citation

Brilakis ES, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Haagen D, Saeed B, Gadiparthi C, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S. A randomized controlled trial of a paclitaxel-eluting stent — View Citation

Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Holper EM, Haagen D, Saeed B, Iturbe JM, Shunk K, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S, Brilakis ES. Clinical presentation and angiographic char — View Citation

Michael TT, Abdel-karim AR, Papayannis A, Lichtenwalter C, de Lemos JA, Obel O, Addo T, Roesle M, Haagen D, Rangan BV, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger PB, Banerjee S, Brilakis ES. Recurrent ca — View Citation

Michael TT, Badhey N, Banerjee S, Brilakis ES. Comparison of characteristics and outcomes of patients undergoing saphenous vein graft stenting who were or were not enrolled in the stenting of saphenous vein grafts randomized controlled trial. J Investig M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography		12 months	No
Secondary	intrastent intimal hyperplasia accumulation as measured by IVUS		12 months for IVUS and 24 months for clinical follow-up	Yes
Secondary	incidence of ischemia-driven target vessel revascularization, target vessel failure, and overall major adverse cardiac and cerebrovascular events at 24-month follow-up		12 months for IVUS and 24 months for clinical follow-up	Yes

External Links

•   Trial main website