This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The current standard of care proposes coronary artery bypass surgery (CABG) as the desirable treatment option in diabetic patients with multi-vessel coronary artery disease (CAD). This is based on a subgroup analysis of the BARI trial (Bypass Angioplasty Revascularization Investigation; SPID #1030). However, the BARI patient registry did not confirm an advantage for CABG over stenting, and many centers continue to stent. Both cardiac surgical techniques and stenting techniques have evolved. The objective of this study is to evaluate whether percutaneous coronary intervention (PCI) with drug-eluting stenting (PCI/DES) is more or less effective than the existing standard of care, coronary artery bypass surgery (CABG). The subject population will be 2,400 adults with diabetes mellitus (Type 1 or Type 2) with angiographically confirmed multivessel CAD and morphology amenable to either PCI or CABG, with indication for revascularization based upon symptoms or angina and/or objective evidence of myocardial ischemia. 20 subjects are expected to be enrolled at NYU.This is a multicenter, two-arm, open-label, prospective, randomized superiority trial with equal allocation, of 5 years duration with a minimum of 3 years of follow-up. Patients who consent will be randomized on a 1:1 basis either to CABG or multivessel stenting using drug-eluting stents, and followed at 30 days, 1 year and then annually for at least 3 years but up to 5 years. A registry of 2000 patients will also be recruited concurrently, comprised of eligible non-consenting patients for the randomized trial.The primary endpoint is the composite of all-cause mortality, nonfatal myocardial infarction and stroke at the end of the 5-year patient accrual and follow-up period (minimum follow-up 3 years).
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