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

NCT01121224 | Completed Phase 4 Results DMC FDA Device

• 1 other identifier: 571
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 25

Brief Summary

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 Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs.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.

Conditions

Saphenous Vein Graft Atherosclerosis

Keywords

Saphenous vein graft; Percutaneous coronary intervention; Stents

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death

  12 months

• Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction

  12 months

• Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization

  12 months

Secondary Outcomes (26)

• Incremental Cost-effectiveness of DES Relative to BMS

  12 months

• Procedural Success

  Discharge from Index Hospitalization (an average of 36 hours)

• Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.

  Entire Duration of Follow-up (median 2.7 years)

• Number of Participants With Myocardial Infarction (MI)

  Entire Duration of Follow-up (median 2.7 years)

• Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition

  12 months

Study Arms (2)

BMS Group

ACTIVE COMPARATOR

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

Device: Bare Metal Stent; Drug: Placebo; Drug: Thienopyridine (open-label)

DES Group

EXPERIMENTAL

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

Device: Drug-Eluting Stent; Drug: Blinded clopidogrel; Drug: Thienopyridine (open-label)

Interventions

Bare Metal Stent DEVICE

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

Also known as: BMS

BMS Group

Drug-Eluting Stent DEVICE

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

Also known as: DES

DES Group

Blinded clopidogrel DRUG

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

Also known as: Plavix

DES Group

Placebo DRUG

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

BMS Group

Thienopyridine (open-label) DRUG

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.

BMS Group; DES Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 creatine kinase-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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (25)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

Little Rock, Arkansas, 72205-5484, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, 40502, United States

Location

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70112, United States

Location

VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA

West Roxbury, Massachusetts, 02132, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, 65201-5297, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, 28805, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma, 73104, United States

Location

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (3)

• Xenogiannis I, Rangan BV, Uyeda L, Banerjee S, Edson R, Bhatt DL, Goldman S, Holmes DR Jr, Rao SV, Shunk K, Mavromatis K, Ramanathan K, Bavry AA, McFalls EO, Garcia S, Thai H, Uretsky BF, Latif F, Armstrong E, Ortiz J, Jneid H, Liu J, Aggrawal K, Conner TA, Wagner T, Karacsonyi J, Ventura B, Alsleben A, Lu Y, Shih MC, Brilakis ES. In-Stent Restenosis in Saphenous Vein Grafts (from the DIVA Trial). Am J Cardiol. 2022 Jan 1;162:24-30. doi: 10.1016/j.amjcard.2021.09.024. Epub 2021 Nov 1.

  PMID: 34736721 DERIVED

• Latif F, Uyeda L, Edson R, Bhatt DL, Goldman S, Holmes DR Jr, Rao SV, Shunk K, Aggarwal K, Uretsky B, Bolad I, Ziada K, McFalls E, Irimpen A, Truong HT, Kinlay S, Papademetriou V, Velagaleti RS, Rangan BV, Mavromatis K, Shih MC, Banerjee S, Brilakis ES. Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial. Circ Cardiovasc Interv. 2020 Feb;13(2):e008494. doi: 10.1161/CIRCINTERVENTIONS.119.008494. Epub 2020 Feb 5.

  PMID: 32019343 DERIVED

• Brilakis ES, Edson R, Bhatt DL, Goldman S, Holmes DR Jr, Rao SV, Shunk K, Rangan BV, Mavromatis K, Ramanathan K, Bavry AA, Garcia S, Latif F, Armstrong E, Jneid H, Conner TA, Wagner T, Karacsonyi J, Uyeda L, Ventura B, Alsleben A, Lu Y, Shih MC, Banerjee S; DIVA Trial Investigators. Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial. Lancet. 2018 May 19;391(10134):1997-2007. doi: 10.1016/S0140-6736(18)30801-8. Epub 2018 May 11.

  PMID: 29759512 DERIVED

MeSH Terms

Interventions

Drug-Eluting Stents; Clopidogrel; thienopyridine

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Subhash Banerjee
• Organization: VA North Texas Health Care System

Subhash.Banerjee@va.gov

(214) 857-1608

Study Officials

• Emmanouil S Brilakis, MD PhD

  VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

  STUDY CHAIR

• Subhash Banerjee, MD

  VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 12, 2010
• Study Start: January 11, 2012
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: July 26, 2022
• Results First Posted: February 1, 2018

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)