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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)

 

Data Sharing Statement

What's available?

Pending

Available Documentation

Pending

Dates Data are Available

Pending

Access Criteria

Pending

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, double-blinded 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

Response Rate

N/A

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 outcomes

  • 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 outcomes

  • 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

  • Interviews (in-person, telephone)
  • Physical exams
  • Participant medical records

Funding Source

VA Cooperative Studies Program (CSP)

Contact

Pending

Selected Publication

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