Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

Emmanouil S. Brilakis, Subhash Banerjee, Robert Edson, Kendrick Shunk, Steven Goldman, David Holmes, Deepak L. Bhatt, Sunil V. Rao, Mark W. Smith, Mike Sather, Cindy Colling, Biswajit Kar, Lori Nielsen, Todd Conner, Todd Wagner, Bavana V. Rangan, Beverly Ventura, Ying Lu, Mark Holodniy, Mei Chiung Shih

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)946-954
Number of pages9
JournalClinical Cardiology
Volume40
Issue number11
DOIs
StatePublished - Nov 1 2017

Fingerprint

Drug-Eluting Stents
Saphenous Vein
Angioplasty
Stents
clopidogrel
Metals
Transplants
Incidence
Acute Coronary Syndrome
Random Allocation
Cost-Benefit Analysis
Diabetes Mellitus
Myocardial Infarction
Placebos

Keywords

  • Outcomes
  • Percutaneous Coronary Intervention
  • Saphenous Vein Grafts

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial. / Brilakis, Emmanouil S.; Banerjee, Subhash; Edson, Robert; Shunk, Kendrick; Goldman, Steven; Holmes, David; Bhatt, Deepak L.; Rao, Sunil V.; Smith, Mark W.; Sather, Mike; Colling, Cindy; Kar, Biswajit; Nielsen, Lori; Conner, Todd; Wagner, Todd; Rangan, Bavana V.; Ventura, Beverly; Lu, Ying; Holodniy, Mark; Shih, Mei Chiung.

In: Clinical Cardiology, Vol. 40, No. 11, 01.11.2017, p. 946-954.

Research output: Contribution to journalArticle

Brilakis, ES, Banerjee, S, Edson, R, Shunk, K, Goldman, S, Holmes, D, Bhatt, DL, Rao, SV, Smith, MW, Sather, M, Colling, C, Kar, B, Nielsen, L, Conner, T, Wagner, T, Rangan, BV, Ventura, B, Lu, Y, Holodniy, M & Shih, MC 2017, 'Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial', Clinical Cardiology, vol. 40, no. 11, pp. 946-954. https://doi.org/10.1002/clc.22763
Brilakis, Emmanouil S. ; Banerjee, Subhash ; Edson, Robert ; Shunk, Kendrick ; Goldman, Steven ; Holmes, David ; Bhatt, Deepak L. ; Rao, Sunil V. ; Smith, Mark W. ; Sather, Mike ; Colling, Cindy ; Kar, Biswajit ; Nielsen, Lori ; Conner, Todd ; Wagner, Todd ; Rangan, Bavana V. ; Ventura, Beverly ; Lu, Ying ; Holodniy, Mark ; Shih, Mei Chiung. / Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial. In: Clinical Cardiology. 2017 ; Vol. 40, No. 11. pp. 946-954.
@article{2e6eee73e62844af8c32a7a0fc4af3dc,
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 David Holmes 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}",
year = "2017",
month = "11",
day = "1",
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",

}

TY - JOUR

T1 - Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial

AU - Brilakis, Emmanouil S.

AU - Banerjee, Subhash

AU - Edson, Robert

AU - Shunk, Kendrick

AU - Goldman, Steven

AU - Holmes, David

AU - Bhatt, Deepak L.

AU - Rao, Sunil V.

AU - Smith, Mark W.

AU - Sather, Mike

AU - Colling, Cindy

AU - Kar, Biswajit

AU - Nielsen, Lori

AU - Conner, Todd

AU - Wagner, Todd

AU - Rangan, Bavana V.

AU - Ventura, Beverly

AU - Lu, Ying

AU - Holodniy, Mark

AU - Shih, Mei Chiung

PY - 2017/11/1

Y1 - 2017/11/1

N2 - 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.

AB - 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.

KW - Outcomes

KW - Percutaneous Coronary Intervention

KW - Saphenous Vein Grafts

UR - http://www.scopus.com/inward/record.url?scp=85028542432&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85028542432&partnerID=8YFLogxK

U2 - 10.1002/clc.22763

DO - 10.1002/clc.22763

M3 - Article

C2 - 28841230

AN - SCOPUS:85028542432

VL - 40

SP - 946

EP - 954

JO - Clinical Cardiology

JF - Clinical Cardiology

SN - 0160-9289

IS - 11

ER -