Background In the BARI 2D trial, patients with type 2 diabetes and stable coronary artery disease were randomized to prompt revascularization versus intensive medical therapy (IMT). This analysis sought to evaluate how the availability of drug-eluting stents (DESs) has changed practice and outcomes. Methods In BARI 2D, 1,605 patients were in the percutaneous coronary intervention (PCI)-intended stratum. As DES became available midway through recruitment, we report clinical outcomes among patients who underwent IMT versus prompt PCI with bare-metal stents (BMSs) or DES up to 4 years. Results In North America, after DES became available, selection for the PCI-intended stratum increased from 73% to 79% (P =.003). Fewer BMS than DES patients had total occlusions treated or underwent rotational atherectomy (5.6% vs 9.7%, P =.02, and 1.2% vs 3.7%, P <.01, respectively). Subsequent revascularization (IMT 39%, BMS 29%, DES 21%, P <.01) and target vessel revascularization (BMS 16.1% vs DES 9.6%, P =.03) were lower with DES. Angina at 2 years tended to be less common with DES (IMT 39%, BMS 37%, DES 29%, P =.04, for 3 groups, P =.07 for DES vs BMS). The composite of death, myocardial infarction, or stroke was IMT 16.0%, BMS 20.5%, DES 17.5%; P =.80. Conclusions When DES became available in North America, patients were more likely to be selected into the PCI-intended stratum. Compared with patients receiving BMS, those receiving DES tended to have less target vessel revascularization and angina.
Bibliographical noteFunding Information:
Dr Shah was funded by the American College of Cardiology Foundation/Merck Research Fellowship Award (2011-2012) and the National Institutes of Health/National Heart, Lung and Blood Institute (T32HL098129) (2012-2013). The BARI 2D trial was sponsored by the National Heart, Lung and Blood Institute and received funding from the NIDDK (U01 HL061744, U01 HL061746, U01 HL061748, U01 HL063804); GlaxoSmithKline; Lantheus Medical Imaging, Inc; AstellasPharma US, Inc; Merck & Co, Inc; Abbott Laboratories, Inc; Pfizer, Inc; Abbott Laboratories Ltd; MediSense Products; Bayer Diagnostics; Becton Dickinson and Company; J. R. Carlson Laboratories, Inc; Centocor, Inc; Eli Lilly and Company; LipoScience, Inc; Merck Sante; Novartis Pharmaceuticals Corporation; and Novo Nordisk, Inc. The BARI 2D trial was coordinated by the Epidemiology Data Center at the University of Pittsburgh, Graduate School of Public Health. The authors are solely responsible for the study design and analyses and drafting and editing of the manuscript and its final contents.