@article{743f29c2bded4994863088c4b65b63d3,
title = "Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial",
abstract = "VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare-metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12-months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open-label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12-month incidence of target-vessel failure (defined as the composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost-effectiveness of DES relative to BMS. Due to lower-than-anticipated target-vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.",
keywords = "Outcomes, Percutaneous Coronary Intervention, Saphenous Vein Grafts",
author = "Brilakis, {Emmanouil S.} and Subhash Banerjee and Robert Edson and Kendrick Shunk and Steven Goldman and Holmes, {David R.} and Bhatt, {Deepak L.} and Rao, {Sunil V.} and Smith, {Mark W.} and Mike Sather and Cindy Colling and Biswajit Kar and Lori Nielsen and Todd Conner and Todd Wagner and Rangan, {Bavana V.} and Beverly Ventura and Ying Lu and Mark Holodniy and Shih, {Mei Chiung}",
note = "Funding Information: This research was supported by the Department of Veterans Affairs, Cooperative Studies Program (125), 810 Vermont Avenue NW, Washington, DC 20420. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or any US government agency. Funding Information: Emmanouil Brilakis has received consulting/speaker honoraria from Abbott Vascular, Amgen, Asahi, Elsevier, GE Healthcare, and Medi-cure; has received research support from Osprey Medical and Boston Scientific; and his spouse is an employee of Medtronic. Subhash Banerjee reports honoraria from Medtronic, CSI, and AstraZeneca, and institutional research grants from Merck and Boston Scientific. Kendrick Shunk reports consulting for Medeon Biodesign, Inc., Trans-aortic Medical, and Terumo, and research support from Siemens Medical Systems and Medinol. Steven Goldman has received research support from the National Institutes of Health, the Arizona Biomedical Research Commission, and Merck Pharmaceuticals; he is co-founder of Avery Therapeutics. Deepak L. Bhatt has served on the advisory board for Cardax, Elsevier PracticeUpdate Cardiology, Meds-cape Cardiology, and Regado Biosciences; has served on the board of directors for Boston VA Research Institute and the Society of Cardiovascular Patient Care; has been chair of the American Heart Association Quality Oversight Committee; has served on data monitoring committees for Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, and Population Health Research Institute; has received honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, acc.org), Belvoir Publications (editor in chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (editor in chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor; associate editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (chief medical editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (CME steering committees); reports positions with Clinical Cardiology (deputy editor), NCDR-ACTION Registry Steering Committee (chair), and VA CART Research and Publications Committee (chair); has received research funding from Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi-Aventis, and The Medicines Company; has received royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); served as site coinvestigator for Biotronik, Boston Scientific, and St. Jude Medical (now Abbott); has served as a trustee for the American College of Cardiology; and reports unfunded research with FlowCo, Merck, PLx Pharma, and Takeda. Sunil V. Rao has served as a consultant for Med-tronic. Bavana Rangan has received research grants from Infraredx and Spectranetics Corporation. Robert Edson, David R. Holmes Jr., Mark W. Smith, Mike Sather, Cindy Colling, Biswajit Kar, Lori Nielsen, Todd Conner, Todd Wagner, Beverly Ventura, Ying Lu, Mark Holod-niy, and Mei-Chiung Shih report no conflicts. The authors report no other conflicts to disclose. Publisher Copyright: {\textcopyright} 2017 Wiley Periodicals, Inc.",
year = "2017",
month = nov,
doi = "10.1002/clc.22763",
language = "English (US)",
volume = "40",
pages = "946--954",
journal = "Clinical Cardiology",
issn = "0160-9289",
publisher = "John Wiley and Sons Inc.",
number = "11",
}