CSP #571: Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CSP #571: Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty (DIVA)

 

Investigator Access

What's Available

 



Check with publications for information and a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

To assess the risks and benefits of drug-eluting stents (DES) versus bare-metal stents (BMS) in de-novo saphenous vein bypass graft (SVG) lesions.

Era of Service

All

Population

Patients 18 years and older who have had at least one significant de-novo SVG lesion requiring percutaneous coronary intervention (PCI) with intent to use embolic protection devices.

Study Design

Randomized, parallel, triple-blind clinical trial

Interventions 

  • Arm 1 (Active Comparator): BMS in the SVG lesion(s)
  • Arm 2 (Experimental): DES in the SVG lesion(s)

Time Period

January 2012 - December 2016

Setting

National

N

597 participants

Response Rate

Unconfirmed

Recruitment Method

  • Patients were recruited from 25 VA medical centers
  • All patients with prior coronary artery bypass graft surgery scheduled to undergo coronary angiography and/or percutaneous intervention to a SVG were screened

Compensation

$25 for each in-person follow-up visit (up to $175)

Data Collected

Primary outcome

  • 12-month incidence of target vessel failure (TVF), defined as a composite of: cardia death, target vessel myocardial infarction, and target vessel revascularization

Secondary outcome

  • Clinical outcomes other than target vessel failure, including procedural success/complications, all-cause and cardiac death, follow-up myocardial infarction, stent thrombosis, target lesion/vessel revascularization, target and non-target vessel revascularization, stroke
  • Composite endpoint of any death, any myocardial infarction and target vessel revascularization (patient-oriented composite endpoint)
  • Incremental cost-effectiveness of DES relative to BMS 

Tertiary outcome

  • In-stent neointima proliferation as measured by intravascular ultrasonography

Other assessments

  • Demographics and medical history
  • Physical examination, electrocardiogram, laboratory tests, cardiac enzymes, graft angiography and PCI
  • Quality of life

Data Collection Methods

Study coordinators collected data from patients for the study forms via in-person or phone interviews. For in-person visits, a brief physical examination was performed. Clinical data were obtained from the participants’ medical records. Sites entered patient data directly into a web-based database.

Funding Source

VA Cooperative Studies Program (CSP)

Contact

Unconfirmed

Selected Publications

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-blinded randomized trial. Lancet. 2018 May 19;391(10134):1997-2007.

More Information

  • Study ClinicalTrials.gov site
  • ClinicalTrials.gov Identifier: NCT01121224
  • Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)