TY - JOUR
T1 - Drug-eluting stents versus bare-metal stents in saphenous vein grafts
T2 - a double-blind, randomised trial
AU - DIVA Trial Investigators
AU - Brilakis, Emmanouil S.
AU - Edson, Robert
AU - Bhatt, Deepak L.
AU - Goldman, Steven
AU - Holmes, David R.
AU - Rao, Sunil V.
AU - Shunk, Kendrick
AU - Rangan, Bavana V.
AU - Mavromatis, Kreton
AU - Ramanathan, Kodangudi
AU - Bavry, Anthony A.
AU - Garcia, Santiago
AU - Latif, Faisal
AU - Armstrong, Ehrin
AU - Jneid, Hani
AU - Conner, Todd A.
AU - Wagner, Todd
AU - Karacsonyi, Judit
AU - Uyeda, Lauren
AU - Ventura, Beverly
AU - Alsleben, Aaron
AU - Lu, Ying
AU - Shih, Mei Chiung
AU - Banerjee, Subhash
AU - Ahmed, Bina
AU - Ratliff, D. Michelle
AU - Ricciardi, Mark
AU - Sheldon, Mark
AU - Icenogle, Milton
AU - Snider, Richard
AU - Ardati, Amer
AU - Nallamothu, Brahmajee
AU - Duvernoy, Claire
AU - Menees, Daniel S.
AU - Gurm, Hitinder
AU - Thomas, Michael P.
AU - Grossman, Paul
AU - Owen, Kristine
AU - Topaz, On
AU - Kumar, Gautam
AU - Mavromatis, Kreton
AU - Block, Peter
AU - Zidar, David A.
AU - Bezerra, Hiram
AU - Goldberg, Jonathan
AU - Ortiz, Jose
AU - Jozic, Joseph
AU - Osman, Mohammed
AU - Rosenthal, Noah
AU - Jneid, Hani
N1 - Publisher Copyright:
© 2018 Elsevier Ltd
PY - 2018/5/19
Y1 - 2018/5/19
N2 - Background: Few 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. Methods: 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. Findings: 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. Interpretation: 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. Funding: US Department of Veterans Affairs Cooperative Studies Program.
AB - Background: Few 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. Methods: 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. Findings: 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. Interpretation: 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. Funding: US Department of Veterans Affairs Cooperative Studies Program.
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U2 - 10.1016/S0140-6736(18)30801-8
DO - 10.1016/S0140-6736(18)30801-8
M3 - Article
C2 - 29759512
AN - SCOPUS:85046864292
SN - 0140-6736
VL - 391
SP - 1997
EP - 2007
JO - The Lancet
JF - The Lancet
IS - 10134
ER -