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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01121224
First received: May 7, 2010
Last updated: August 10, 2016
Last verified: August 2016
  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 Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs.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:


Further study details as provided by VA Office of Research and Development:

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: 762
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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), or components of the platinum chromium alloy stent.
  • 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) for which dual enrollment with DIVA is not approved
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723
United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
United States, Kentucky
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States, 40502
United States, Louisiana
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, United States, 65201-5297
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010
United States, North Carolina
Asheville VA Medical Center, Asheville, NC
Asheville, North Carolina, United States, 28805
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Emmanouil S Brilakis, MD PhD VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01121224     History of Changes
Other Study ID Numbers: 571 
Study First Received: May 7, 2010
Last Updated: August 10, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Saphenous vein graft
Percutaneous coronary intervention
Stents

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
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 September 28, 2016