Emmanouil S Brilakis1, Robert Edson2, Deepak L Bhatt3, Steven Goldman4, David R Holmes5, Sunil V Rao6, Kendrick Shunk7, Bavana V Rangan8, Kreton Mavromatis9, Kodangudi Ramanathan10, Anthony A Bavry11, Santiago Garcia12, Faisal Latif13, Ehrin Armstrong14, Hani Jneid15, Todd A Conner16, Todd Wagner17, Judit Karacsonyi8, Lauren Uyeda2, Beverly Ventura2, Aaron Alsleben2, Ying Lu18, Mei-Chiung Shih19, Subhash Banerjee8. 1. VA North Texas Health Care System, Dallas, TX, USA; Minneapolis Heart Institute, Minneapolis, MN, USA; University of Texas Southwestern Medical School, Dallas, TX, USA. Electronic address: esbrilakis@gmail.com. 2. VA Cooperative Studies Program Coordinating Center, Mountain View, CA, USA. 3. VA Boston Healthcare System, Boston, MA, USA; Brigham and Women's Hospital Heart and Vascular Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. 4. University of Arizona, Sarver Heart Center, Tucson, AZ, USA. 5. Mayo Clinic School of Graduate Medical Education, Rochester, MN, USA. 6. Durham VA Medical Center, Durham, NC, USA; Duke University, Durham, NC, USA. 7. San Francisco VA Medical Center, San Francisco, CA, USA; University of California San Francisco, San Francisco, CA, USA. 8. VA North Texas Health Care System, Dallas, TX, USA; University of Texas Southwestern Medical School, Dallas, TX, USA. 9. Atlanta VA Medical Center, Atlanta, GA, USA; Emory University, Atlanta, GA, USA. 10. Memphis VA Medical Center, Memphis, TN, USA; University of Tennessee, Memphis, TN, USA. 11. North Florida/South Georgia Veterans Health System, Gainesville, FL, USA; University of Florida, Gainesville, FL, USA. 12. Minneapolis VA Medical Center, Minneapolis, MN, USA; University of Minnesota, Minneapolis, MN, USA. 13. Oklahoma VA Medical Center, Oklahoma City, OK, USA; University of Oklahoma, Oklahoma City, OK, USA. 14. Denver VA Medical Center, Denver, CO, USA; University of Colorado, Denver, CO, USA. 15. Michael E DeBakey VA Medical Center, Houston, TX, USA; Baylor College of Medicine, Houston, TX, USA. 16. VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA. 17. VA Health Economics Resource Center, Menlo Park, CA, USA; Department of Surgery, Stanford University, CA, USA. 18. Department of Health Research and Policy, Stanford University, Stanford, CA, USA. 19. VA Cooperative Studies Program Coordinating Center, Mountain View, CA, USA; Department of Health Research and Policy, Stanford University, Stanford, CA, USA.
Abstract
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.
RCT Entities:
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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