Secondary Analysis of TUXEDO Compares PCI in Patients With Insulin-Treated and Non–Insulin-Treated Diabetes Mellitus

April 25, 2016—Sripal Bangalore, MD, et al published findings from a study conducted to assess the outcomes of patients with insulin-treated diabetes mellitus (ITDM) versus non-ITDM patients who underwent percutaneous coronary intervention (PCI) and to assess the efficacy and safety of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES) based on insulin use status. The study is available online ahead of print in Journal of the American Medical Association (JAMA): Cardiology.

The investigators concluded that patients with ITDM had a significant increase in the risk of cardiovascular events in unadjusted models that was largely attenuated after propensity score adjustment; additionally, EES reduced the rate of cardiovascular events, including stent thrombosis, when compared with PES in patients with ITDM.

As summarized in JAMA: Cardiology, this study was a prespecified analysis of TUXEDO, the Taxus Element Versus Xience Prime in a Diabetic Population clinical trial, which enrolled 1,830 patients with ITDM and non-ITDM from June 23, 2011, to March 12, 2014. Patients were randomized 1:1 to receive either a PES or EES. The primary endpoint was target vessel failure (TVF), which was defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization, at 1 year after the intervention. Of the 1,830 patients (1,377 men) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). The non-ITDM group included 1,083 patients.

The investigators found that ITDM patients compared to non-ITDM patients had a significant increase in TVF (42 [5.6%] vs 36 [3.3%]), death or myocardial infarction (43 [5.8%] vs 35 [3.2%]), death (26 [3.5%] vs 18 [1.7%]), and subacute stent thrombosis (8 [1.1%] vs 3 [0.3%]). However, in a propensity score–adjusted analysis to account for baseline differences between the two groups, the differences in outcomes were no longer significant.

In patients with ITDM, EES reduced the rate of TVF (13 of 382 [3.4%] vs 29 of 365 [7.9%]), major adverse cardiac events (15 of 382 [3.9%] vs 30 of 365 [8.2%]), myocardial infarction (5 of 382 [1.3%] vs 16 of 365 [4.4%]), stent thrombosis (2 of 382 [0.5%] vs 11 of 365 [3%]), target lesion revascularization (4 of 382 [1%] vs 19 of 365 [5.2%]), and target vessel revascularization (4 of 382 [1%] vs 19 of 365 [5.2%]) when compared with PES. The results largely trended in the same direction in patients with non-ITDM, reported the investigators in JAMA: Cardiology.