Presenting angina severity does not significantly alter the efficacy of treatment strategies on cardiovascular outcomes in patients with type 2 diabetes (T2D) and stable coronary artery disease (CAD), according to a pooled, post-hoc analysis of 3 clinical trials, recently published in Atherosclerosis.
The trials included BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes), COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation), and FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multi-vessel Disease) — all federally funded.
Participants (n=5027) in this pooled-analysis had T2D and stable CAD. Patient cohorts were divided into 3 groups according to treatment strategy: optimal medical therapy (OMT), percutaneous coronary intervention (PCI) plus OMT, or coronary artery bypass grafting (CABG) plus OMT. Primary end points included death/myocardial infarction (MI)/stroke and post-randomization revascularization, both over 5 years, and angina control at 1 year.
The analysis demonstrated an association between severity of baseline angina and rates of death/MI/stroke. In addition, there was an association between baseline severity and the increased the need for post-randomization revascularization (P =.001). Multivariable adjustment showed only post-randomization revascularization was significant.
The superiority of CABG plus OMT in reducing death/MI/stroke and post-randomization revascularization compared with PCI plus OMT or OMT alone, was not affected by baseline angina severity. However, the superiority of CABG plus OMT in controlling angina at 1 year was greater in patients with ≥Class II severity at baseline. PCI plus OMT was superior to OMT alone for reducing the rate of post-randomization revascularization regardless of presenting angina severity.
PCI plus OMT was comparable with OMT alone in reducing cardiovascular outcomes, except with post-randomization revascularization. This pattern was not affected by presenting angina.
Although there are limitations to post-hoc analyses, “our study is the most comprehensive assessment to date of the influence of baseline angina severity on prognosis and treatment outcomes and it was undertaken in the largest, available pooled cohort of over 5000 stable CAD patients with [T2D] suitable for revascularization,” the investigators wrote.
Disclosures: Funding was provided by Gilead Pharmaceuticals. Several authors declare affiliations with the pharmaceutical industry, please refer to full text for a list of disclosures.
Mancini GBJ, Boden WE, Brooks MM, et al. Impact of treatment strategies on outcomes in patients with stable coronary artery disease and type 2 diabetes mellitus according to presenting angina severity: A pooled analysis of three federally-funded randomized trials [published online May 31, 2018]. Atherosclerosis. doi.org/10.1016/j.atherosclerosis.2018.04.005