TUXEDO-India Affirms Superiority of EES in Patients With Diabetes
Patients with diabetes and CAD fare better in the first year after PCI if they receive an everolimus-eluting stent (EES) rather than a paclitaxel-eluting stent (PES), according to results of the TUXEDO-India trial presented at TCT 2015 and published simultaneously in the New England Journal of Medicine.
The trial, conducted at 46 centers in India and led by Upendra Kaul, MD, of Fortis Escorts Hospital, in New Delhi, India, randomized 1,830 patients with diabetes, either stable CAD or ACS, and up to three lesions to PCI with the paclitaxel-eluting Taxus Element (Boston Scientific Corporation) or everolimus-eluting Xience Prime (Abbott Vascular). Predilatation was mandatory, and dual antiplatelet therapy was given for at least 12 months after the procedure. Patients in the Xience Prime group were more likely to take clopidogrel and less likely to take ticagrelor (Brilinta, AstraZeneca) or prasugrel (Effient, Eli Lilly and Company) than were those in Taxus Element group.
At 1 year, the primary endpoint of target vessel failure (TVF; cardiac death, target-vessel MI and ischemia-driven target vessel revascularization) occurred in 5.6% of the Taxus patients and 2.9% of the Xience Prime patients. That difference failed to meet criteria for the noninferiority of Taxus vs. Xience Prime (P = .38 for noninferiority). Superiority testing confirmed that the rate was significantly lower with Xience Prime (P = .005), a finding that was consistent across nearly all subgroups studied, including patients requiring insulin.
The disparity in TVF was driven by lower rates of target-vessel MI (0.5% vs. 2.8%; P < .001) and ischemia-driven TVR (1.2% vs. 3.4%; P = .002) with Xience Prime. There were no differences in all-cause or cardiac death, but Academic Research Consortium-defined stent thrombosis was more frequent in the Taxus arm (2.1% vs. 0.4%; P = .002).
“The study supports the current worldwide practice of use of new-generation limus-eluting stents, even in patients who require insulin for management of their diabetes,” Kaul said.
Implications for U.S. practice
Taxus is now rarely used in U.S. cath labs, but Kaul said there had still been a lingering question about whether there was a difference in performance between PES and EES in patients with diabetes. TUXEDO-India provides a definitive answer, he said, and also raises some questions about the results of FREEDOM and BARI-2D, which compared CABG with inferior first-generation stents.
At a related press conference, Bernard J. Gersh, MBChB, DPhil, of the Mayo Clinic, in Rochester, Minn., agreed, noting that guidelines on PCI and CABG in patients with diabetes are based on those studies, as well as on the SYNTAX trial. How to interpret trials that are obsolete at completion because they take several years to perform is a dilemma, he said. The findings of TUXEDO-India and other studies pointing to the superiority of EES over other stents do not invalidate the results of the earlier PCI vs. CABG trials, he added, but they suggest that the advantage of CABG in patients with diabetes might not be as great as previously believed.
Gersh, noting that “the guidelines still leave room for individual judgment,” said CABG remains the treatment of choice in diabetic patients with high Syntax scores and very diffuse coronary disease. For those with more focal disease, however, either CABG or PCI could be chosen after a discussion involving an interventional cardiologist, a surgeon and the patient, he said.
- Gersh reports relationships with multiple pharmaceutical and device companies.
- Kaul reports receiving grant/research support from Boston Scientific Corporation and speakers bureau fees from Abbott Vascular.
- The trial was funded by Boston Scientific Corporation.