Current status of percutaneous coronary interventions in diabetics with multivessel disease - is it time to challenge FREEDOM?

Abstract

Diabetes mellitus (DM) and coronary artery disease (CAD) are the leading causes of death in the world. Over the last two decades, clinical trials have indicated that DM patients with CAD have poorer cardiac outcomes than non-diabetic patients with CAD. The pivotal findings of the FREEDOM trial greatly impacted the way clinicians approached revascularisation in diabetic patients with multivessel disease (MVD). However, since the publication of the FREEDOM trial, much has changed both in percutaneous coronary intervention (PCI) technology, as well as in the management of diabetes. This review provides insights into advancements in stent technology, enhanced patient management strategies, improved clinical outcomes with newer hypoglycaemic agents, current approaches to antiplatelet therapy, and advances in lipid management in diabetic patients. The influence of patient-specific factors such as comorbidities and anatomical complexities on treatment decisions in diabetic patients with MVD is also discussed. The ongoing TUXEDO-2 India trial was designed to primarily compare the clinical outcomes of PCI with the new-generation ultrathin-strut Supraflex Cruz stent, compared to the second-generation XIENCE stent in the setting of contemporary optimal medical therapy in Indian diabetic patients with MVD. The secondary objective of this study is to compare clinical outcomes in the combined group from both study arms against a performance goal derived from the coronary artery bypass grafting (CABG) arm of the FREEDOM trial (historical cohort). The tertiary objective is to compare the efficacy and safety of ticagrelor versus prasugrel in diabetic patients with MVD. In view of recent advances in PCI and medical therapy since the FREEDOM trial, now is an appropriate time to revisit the results of CABG versus PCI in diabetic patients with MVD.