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

May 21, 2018
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Presenter/Author:
Emmanouil S. Brilakis, MD, PhD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Veterans Affairs Cooperative Studies Program
Date Presented:
08/26/2017
Date Published:
05/11/2018
Date Updated:
05/21/2018
Original Posted Date:
08/26/2017
References

Contribution To Literature:

The DIVA trial failed to show that DES were superior to BMS at preventing target vessel failure.

Description:

The goal of the trial was to evaluate drug-eluting stents (DES) compared with bare-metal stents (BMS) among patients with saphenous vein graft lesions undergoing percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel
  • Blinded

Patients with saphenous vein graft lesions undergoing PCI were randomized to DES (n = 292) versus BMS (n = 305).

  • Total number of enrollees: 597
  • Duration of follow-up: median 2.7 years
  • Mean patient age: 69 years
  • Percentage female: 1%
  • Percentage with diabetes: 59%

Inclusion criteria:

  • Patients at least 18 years of age
  • Saphenous vein graft lesion undergoing PCI
  • Intent to use embolic protection device

Exclusion criteria:

  • Planned noncardiac surgery within 12 months
  • Target saphenous vein graft in the last remaining vessel
  • Any prior treatment of the target lesion
  • Prior treatment of the target vessel within the last 12 months
  • Bleeding abnormality or use of warfarin
  • Limited life expectancy
  • Allergy to any study drug or device
  • Participation in another randomized trial

Other salient features/characteristics:

  • Unfractionated heparin: 57%
  • Embolic protection: 69%

Principal Findings:

The primary outcome, incidence of target vessel failure at 12 months (cardiac death, target vessel myocardial infarction [MI], or target vessel revascularization), occurred in 17% of the DES group versus 19% of the BMS group (p = 0.67).

Secondary outcomes:

  • Target vessel failure at median 2.7 years: 37% for DES vs. 34% for BMS (p = 0.46)  
  • Deaths at median 2.7 years: 19% for DES vs. 17% for BMS (p = 0.54)
  • Target vessel MI at median 2.7 years: 12% for DES vs. 13% for BMS (p = 0.76) 

Interpretation:

Among patients with a saphenous vein graft lesion undergoing PCI, DES were not superior to BMS at preventing target vessel failure. Outcomes were similar among all individual outcomes. Relatively small trials had been inconclusive in evaluating the comparative effectiveness of DES versus BMS. DIVA is one of the largest trials on the topic and revealed that the use of BMS for saphenous vein graft lesions (for potential cost savings) could be considered.

References:

Brilakis ES, Edson R, Bhatt DL, et al. Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial. Lancet 2018;391:1997-2007.

Editorial Comment: Jeger RV, Möbius-Winkler S. Stents in saphenous vein grafts. Lancet 2018;391:1967-8.

Presented by Dr. Emmanouil S. Brilakis at the European Society of Cardiology Congress, Barcelona, Spain, August 26, 2017.

Keywords: Acute Coronary Syndrome, Angioplasty, Cardiac Surgical Procedures, Drug-Eluting Stents, Embolic Protection Devices, ESC2017, ESC Congress, Heparin, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Saphenous Vein, Secondary Prevention, Stents


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