TUXEDO Trial Compares EES and PES in Diabetic Patients With CAD

October 14, 2015—Results of the TUXEDO trial, which compared two types of drug-eluting stents in diabetic patients, were reported at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation being held October 11–15, in San Francisco, California. The study was published simultaneously online in The New England Journal of Medicine.

TUXEDO found that paclitaxel-eluting stents (PES) failed to meet a noninferiority criterion when compared to everolimus-eluting stents (EES) for the primary endpoint of target vessel failure (TVF) at 1 year.

This investigator-initiated study was composed of 1,830 patients with diabetes mellitus and coronary artery disease undergoing percutaneous coronary intervention (PCI) at 46 centers in India. The patients were randomly assigned to receive either a PES or EES. 

TVF, the primary endpoint of this noninferiorty trial, was defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization (TVR) at 1-year follow-up.

The TUXEDO investigators reported that the PES did not meet the noninferiority criterion for TVF when compared to EES at 1 year (5.6% vs 2.9%; relative risk = 1.89; 95% confidence interval [CI], 1.2–2.99; risk difference = 2.7% [95% CI, 0.78–4.48%; P-noninferiority = .38]). 

In the PES group compared with the EES group, there was a significantly higher 1-year rate of TVF (P = .005), myocardial infarction (3.2% vs 1.2%; P = .004), stent thrombosis (2.1% vs 0.4%; P = .002), TVR (3.4% vs 1.2%; P = .002), and target lesion revascularization (3.4% vs 1.2%; P = .002).

TUXEDO lead investigator Upendra Kaul, MD, commented in the TCT announcement, “In patients with diabetes and coronary artery disease, PESs were inferior to EESs for the primary outcome of TVF and resulted in higher rates of TVF, myocardial infarction, stent thrombosis, and TVR at 1 year. EESs were superior to PESs for several endpoints, including TVF, myocardial infarction, and stent thrombosis.” Dr. Kaul is Executive Director and Dean, Cardiology at the Fortis Escorts Heart Institute and Fortis Vasant Kunj in New Delhi, India.

Dr. Kaul added, “The TUXEDO trial supports the efficacy and safety of limus-eluting stents over PESs in diabetics. The study also questions the ability to translate the findings of previous trials comparing PCI using first-generation stents to coronary bypass surgery in diabetics, as opposed to the current practice of using second-generation drug-eluting stents.”