Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.
AuthorBrilakis, Emmanouil S
Bhatt, Deepak L
Holmes, David R
Rao, Sunil V
Rangan, Bavana V
Bavry, Anthony A
Conner, Todd A
AffiliationUniv Arizona, Sarver Heart Ctr
MetadataShow full item record
PublisherELSEVIER SCIENCE INC
CitationBrilakis, E. S., Edson, R., Bhatt, D. L., Goldman, S., Holmes Jr, D. R., Rao, S. V., ... & Bavry, A. A. (2018). Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial. The Lancet, 391(10134), 1997-2007, DOI:10.1016/S0140-6736(18)30801-8
Rights© 2018 Elsevier Ltd. All rights reserved.
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AbstractFew studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. 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 revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy.
Note6 month embargo; published online: 11 May 2018
VersionFinal accepted manuscript
SponsorsUS Department of Veterans Affairs Cooperative Studies Program
- Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial.
- Authors: Brilakis ES, Banerjee S, Edson R, Shunk K, Goldman S, Holmes DR Jr, 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
- Issue date: 2017 Nov
- In-hospital and 1-year outcomes with drug-eluting versus bare metal stents in saphenous vein graft intervention: a report from the EVENT registry.
- Authors: Tolerico PH, Cohen DJ, Kleiman NS, Berger PB, Brilakis ES, Piana RN, Shammo S, Keyes MJ, Kennedy KF, Massaro JM, Saucedo JF, EVENT Investigators.
- Issue date: 2012 Dec 1
- Safety and effectiveness of drug-eluting versus bare-metal stents in saphenous vein bypass graft percutaneous coronary interventions: insights from the Veterans Affairs CART program.
- Authors: Aggarwal V, Stanislawski MA, Maddox TM, Nallamothu BK, Grunwald G, Adams JC, Ho PM, Rao SV, Casserly IP, Rumsfeld JS, Brilakis ES, Tsai TT
- Issue date: 2014 Oct 28
- Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial.
- Authors: Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schömig A, Kastrati A, Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators.
- Issue date: 2011 Sep 17
- Continued benefit from paclitaxel-eluting compared with bare-metal stent implantation in saphenous vein graft lesions during long-term follow-up of the SOS (Stenting of Saphenous Vein Grafts) trial.
- Authors: Brilakis ES, Lichtenwalter C, Abdel-karim AR, de Lemos JA, Obel O, Addo T, Roesle M, Haagen D, Rangan BV, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S
- Issue date: 2011 Feb