Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty - Full Text View

Purpose

Patients who have undergone coronary bypass surgery have had a vein removed from the leg and implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils that keep the artery open). Two types of stents are currently used: bare metal stents (BMS) and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a drug that releases into the wall of the blood vessel to prevent scar tissue from forming and re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS and DES are routinely being used in SVGs, but it is not known which one is better. Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs.

In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical reason for needing the medication. Patients without ACS who receive DES also need to take 12 months of a thienopyridine whether or not they are in the study, but non-ACS patients who receive a BMS do not. In order to make sure patients do not know which stent they received, non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed by 11 months of blinded placebo, while those who received DES will receive 1 month of open label thienopyridine followed by 11 months of blinded clopidogrel, which is a thienopyridine.

All study patients will be followed in the clinic for at least 1 year after their stenting procedure to see if there is a difference in the rate of cardiac death, heart attack, or any procedure that is required in order to increase the flow of blood to and from the heart between the BMS and DES groups.

Condition	Intervention	Phase
Saphenous Vein Graft Atherosclerosis	Device: Bare Metal Stent Device: Drug-Eluting Stent Drug: Blinded clopidogrel Drug: Placebo Drug: Thienopyridine (open-label)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	CSP #571 - Drug-eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty (DIVA)

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Atherosclerosis Heart Attack

Drug Information available for: Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Target vessel failure (TVF), which will be defined as the composite of cardiac death, target vessel myocardial infarction and target vessel revascularization. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incremental cost-effectiveness of DES relative to BMS. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Procedural success and complications (post-procedural myocardial infarction and post-procedural bleeding). [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]
Death (all cause and cardiac). All deaths will be considered cardiac unless an unequivocal non-cardiac cause can be established. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Myocardial infarction (MI) after discharge from the initial stenting procedure. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Stent thrombosis as defined using the Academic Research Consortium (ARC) definition [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Target vessel revascularization (TVR) and target lesion revascularization TLR). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Patient-oriented and device-oriented (for target lesion failure) composite endpoints will be used as secondary outcomes as proposed by Cutlip et al, and as recommended in the draft FDA guidance for industry statement. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
In patients who clinically require follow-up angiography, two angiographic endpoints will be assessed: (a) in-segment binary restenosis and (b) angiographic late in-segment luminal loss. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Stroke. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Incremental cost-effectiveness ratios (ICERs) for subgroups of patients, such as those with highest risk of restenosis, tallies of cost by type, and a cost-outcomes analysis such as cost per restenosis avoided. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
In-stent neointima proliferation as measured by intravascular ultrasonography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	520
Study Start Date:	January 2012
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).	Device: Bare Metal Stent Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Other Name: BMS Drug: Placebo For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Drug: Thienopyridine (open-label) For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Experimental: Arm 2 Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).	Device: Drug-Eluting Stent Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Other Name: DES Drug: Blinded clopidogrel For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Other Name: Plavix Drug: Thienopyridine (open-label) For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Arms

Assigned Interventions

Active Comparator: Arm 1

Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).

Device: Bare Metal Stent

Patients receive one or more bare metal stents in the saphenous vein graft target lesion.

Other Name: BMS

Drug: Placebo

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.

Drug: Thienopyridine (open-label)

For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Experimental: Arm 2

Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).

Device: Drug-Eluting Stent

Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.

Other Name: DES

Drug: Blinded clopidogrel

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.

Other Name: Plavix

Drug: Thienopyridine (open-label)

For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years
Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.25 and 4.5 mm in diameter and that is considered to cause clinical or functional ischemia
Intent to use a distal embolic protection device
Agrees to participate and to take prescribed medications as instructed
Has provided informed consent and agrees to participate

Exclusion Criteria:

Planned non-cardiac surgery within the following 12 months
Presentation with an ST-segment elevation acute myocardial infarction
Target SVG is the last remaining vessel or is the "left main" equivalent
Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
Hemorrhagic diatheses, or refusal to receive blood transfusions
Warfarin administration required for the next 12 months and patient considered to be at high risk of bleeding with triple anticoagulation/antiplatelet therapy
Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy (defined as no prior hysterectomy or as <5 years elapsing since last menstrual period)
Coexisting conditions that limit life expectancy to less than 12 months
History of an allergic reaction or significant sensitivity to drugs such as sirolimus, paclitaxel, zotarolimus, or everolimus included in various DES. History of an allergic reaction or significant sensitivity to L-605 cobalt chromium alloy (cobalt, silicon, chromium, tungsten, manganese, iron, nickel), F562 cobalt chromium alloy (cobalt, chromium, nickel), 316L surgical stainless steel (iron, chromium, nickel, and molybdenum), or MP35N cobalt-based alloy (cobalt, nickel, chromium, molybdenum, titanium, iron, silicon, and manganese).
Allergy to clopidogrel in patients who do not present with an acute coronary syndrome (ACS), where ACS is defined as cardiac ischemic symptoms occurring at rest and 1 of the following 3 criteria: electrocardiographic changes suggestive of ischemia (ST-segment elevation or depression 1 mm in 2 contiguous leads, or new left bundle branch block, or posterior myocardial infarction); positive biomarker indicating myocardial necrosis (troponin I or T or CK-MB greater than the upper limit of normal); or coronary revascularization performed during hospitalization triggered by the cardiac ischemic symptoms
Participating in another interventional randomized trial (required condition for all CSP studies)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121224

Contacts

Contact: Bavana Rangan, MPH

(214) 857-1562

BavanaV.Rangan@va.gov

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Locations

United States, Arizona
Southern Arizona VA Health Care System, Tucson	Recruiting
Tucson, Arizona, United States, 85723
Contact: Hoang Thai, MD 520-792-1450 ext 5519 hoang.thai@va.gov
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	Recruiting
Little Rock, Arkansas, United States, 72205-5484
Contact: Barry Uretsky, MD 409-771-7994 Barry.Uretsky@va.gov
United States, California
VA Medical Center, San Francisco	Recruiting
San Francisco, California, United States, 94121
Contact: Kendrick Shunk, MD 415-221-4810 ext 3253 kendrick.shunk@va.gov
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO	Recruiting
Denver, Colorado, United States, 80220
Contact: Thomas Tsai, MD 303-399-8020 ext 6105 Thomas.Tsai@va.gov
United States, District of Columbia
VA Medical Center, DC	Suspended
Washington, District of Columbia, United States, 20422
United States, Florida
North Florida/South Georgia Veterans Health System	Recruiting
Gainesville, Florida, United States, 32608
Contact: Anthony Bavry, MD 352-376-1611 ext 6267 Anthony.Bavry@va.gov
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur	Recruiting
Decatur, Georgia, United States, 30033
Contact: Kreton Mavromatis, MD 404-329-2207 kmavro@emory.edu
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL	Recruiting
Hines, Illinois, United States, 60141-5000
Contact: Jayson Liu, MD 708-202-2700 Jayson.Liu@va.gov
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis	Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Islam Bolad, MD 317-988-2093 islam.bolad@va.gov
United States, Kentucky
VA Medical Center, Lexington	Recruiting
Lexington, Kentucky, United States, 40502
Contact: Khaled Ziada, MD 859-323-6195 khaled.ziada@uky.edu
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans	Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Anand Irimpen, MD 504-988-5152 airimpe@tulane.edu
United States, Massachusetts
VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA	Recruiting
West Roxbury, Massachusetts, United States, 02132
Contact: Deepak Bhatt, MD 857-203-6841 Deepak.Bhatt@va.gov
United States, Michigan
VA Ann Arbor Healthcare System	Recruiting
Ann Arbor, Michigan, United States, 48113
Contact: Claire Duvernoy, MD 734-761-7978 duvernoy@med.umich.edu
United States, Minnesota
VA Medical Center, Minneapolis	Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Edward McFalls, MD 612-467-3664 McFal001@umn.edu
United States, Missouri
Harry S. Truman Memorial VA Medical Center	Recruiting
Columbia, Missouri, United States, 65201-5297
Contact: Kul Aggarwal, MD 573-814-6000 ext 53292 AggarwalK@health.missouri.edu
United States, New Mexico
New Mexico VA Health Care System, Albuquerque	Withdrawn
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
New York Harbor HCS	Recruiting
New York, New York, United States, 10010
Contact: Steven Sedlis, MD 212-951-3335 steven.sedlis@va.gov
United States, North Carolina
VA Medical Center, Asheville	Recruiting
Asheville, North Carolina, United States, 28805
Contact: Kristine Owen, MD 828-298-7911 Kristine.Owen@va.gov
VA Medical Center, Durham	Recruiting
Durham, North Carolina, United States, 27705
Contact: Sunil Rao, MD 919-286-0411 ext 7323 sunil.rao@va.gov
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jose Ortiz, MD 216-791-3800 ext 4934 Jose.Ortiz@va.gov
United States, Oklahoma
VA Medical Center, Oklahoma City	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Mazen Abu-Fadel, MD 405-456-1000 mazen.abu-fadel@va.gov
United States, Tennessee
VA Medical Center, Memphis	Recruiting
Memphis, Tennessee, United States, 38104
Contact: K. B Ramanathan, MD 901-577-7355 kodangudi.ramanathan@va.gov
United States, Texas
VA North Texas Health Care System, Dallas	Recruiting
Dallas, Texas, United States, 75216
Contact: Emmanouil S Brilakis, MD PhD 214-857-1556 Emmanouil.Brilakis@va.gov
Contact: Subhash Banerjee, MD (214) 857-1608 subhash.banerjee@va.gov
Study Chair: Emmanouil S Brilakis, MD PhD
Michael E. DeBakey VA Medical Center, Houston, TX	Recruiting
Houston, Texas, United States, 77030
Contact: Hani Jneid, MD 713-794-7309 Mohammad.Jneid@va.gov
United States, Washington
VA Puget Sound Health Care System, Seattle	Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Kenneth Lehmann, MD 206-764-2512 kenneth.lehmann@va.gov

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Study Chair:

Emmanouil S Brilakis, MD PhD

VA North Texas Health Care System, Dallas

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT01121224 History of Changes
Other Study ID Numbers:	571
Study First Received:	May 7, 2010
Last Updated:	April 16, 2013
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

Saphenous vein graft
Percutaneous coronary intervention
Stents

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013

Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty (DIVA)