1. Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial
- Author
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Emmanouil S Brilakis, Robert Edson, Deepak L Bhatt, Steven Goldman, David R Holmes, Sunil V Rao, Kendrick Shunk, Bavana V Rangan, Kreton Mavromatis, Kodangudi Ramanathan, Anthony A Bavry, Santiago Garcia, Faisal Latif, Ehrin Armstrong, Hani Jneid, Todd A Conner, Todd Wagner, Judit Karacsonyi, Lauren Uyeda, Beverly Ventura, Aaron Alsleben, Ying Lu, Mei-Chiung Shih, Subhash Banerjee, Bina Ahmed, D Michelle Ratliff, Mark Ricciardi, Mark Sheldon, Milton Icenogle, Richard Snider, Amer Ardati, Brahmajee Nallamothu, Claire Duvernoy, Daniel S Menees, Hitinder Gurm, Michael P Thomas, Paul Grossman, Kristine Owen, On Topaz, Gautam Kumar, Peter Block, David A Zidar, Hiram Bezerra, Jonathan Goldberg, Jose Ortiz, Joseph Jozic, Mohammed Osman, Noah Rosenthal, Sahil A Parikh, Tom A Lassar, Albert Chan, Arun Kumar, Kul Aggarwal, Tillmann Cyrus, Jerrold Grodin, Brack Hattler, Ivan Casserly, John Messenger, Michael Kim, R Kevin Rogers, Stephen Waldo, Thomas Tsai, Kenneth Morris, Mitchell Krucoff, Sunil Rao, Thomas J Povsic, William S Jones, Anthony Bavry, Calvin Choi, Ki Park, Jayson Liu, MD, Biswajit Kar, David Paniagua, Jeffrey Breall, Islam Bolad, Rita Mukerji, Roopa Subbarao, Ahmed Abdel-Latif, David C Booth, Khaled M Ziada, Lawrence Rajan, Abdul Hakeem, Barry F Uretsky, Mayank Agrawal, Rajesh Sachdeva, Zubair Ahmed, Jesse McGee, Rahman Shah, Alok Sharma, Edward McFalls, Rizwan Siddiqui, Selcuk Adabag, Stefan Bertog, Anand Irimpen, Drew Baldwin, Nidal Abi Rafeh, Owen Mogabgab, Patrice Delafontaine, Jeffrey Lorin, Steven Sedlis, Eliot Schechter, Mazen Abu-Fadel, Talla Rousan, Udho Thadani, Fady Malik, Jeffrey Zimmet, Tony Chou, Alexis Beatty, Kenneth Lehmann, Michael Stadius, Andrew Klein, Caroline Rowe, Megumi Taniuchi, Andrew J Klein, Michael Forsberg, Divya Kapoor, Elizabeth Juneman, Huu Tam Truong, Kapildeo Lotun, Ryan Tsuda, Sergio Thai, Hoang Thai, David Lu, Vasilios Papademetriou, David Faxon, Kevin Croce, Sammy Elmariah, and Scott Kinlay
- Subjects
Graft Rejection ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Clinical Trials and Supportive Activities ,Self Expandable Metallic Stents ,Bioengineering ,030204 cardiovascular system & hematology ,Cardiovascular ,Medical and Health Sciences ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,Double-Blind Method ,law ,Clinical Research ,General & Internal Medicine ,Clinical endpoint ,medicine ,Humans ,Saphenous Vein ,030212 general & internal medicine ,Myocardial infarction ,Veterans Affairs ,Heart Disease - Coronary Heart Disease ,Aged ,Assistive Technology ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,Stent ,Thrombosis ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,medicine.disease ,Atherosclerosis ,Surgery ,Stenosis ,Treatment Outcome ,Heart Disease ,Female ,Patient Safety ,business ,DIVA Trial Investigators - Abstract
Summary 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.
- Published
- 2018