Paclitaxel-Eluting Stent Not Noninferior to Everolimus-Eluting Stent in Diabetes

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Paclitaxel-Eluting Stent Not Noninferior to Everolimus-Eluting Stent in Diabetes
Paclitaxel-Eluting Stent Not Noninferior to Everolimus-Eluting Stent in Diabetes

(HealthDay News) — Paclitaxel-eluting stents are not noninferior to everolimus-eluting stents for patients with diabetes and coronary artery disease undergoing percutaneous coronary intervention (PCI), according to a study published in the New England Journal of Medicine to coincide with the Transcatheter Cardiovascular Therapeutics meeting in San Francisco.

Upendra Kaul, MD, from the Fortis Escorts Heart Institute in India, and colleagues randomly assigned 1830 patients with diabetes and coronary artery disease (CAD) who were undergoing PCI to receive a paclitaxel-eluting stent or an everolimus-eluting stent in a noninferiority trial. 

The primary end point was target-vessel failure (composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization) at 1 year follow-up.

The researchers found that compared with the everolimus-eluting stent group, the paclitaxel-eluting stent group did not meet the criterion for noninferiority with respect to the primary end point at 1 year (2.9% vs 5.6%; P=.38 for noninferiority). 

The 1-year rates of target-vessel failure, spontaneous MI, stent thrombosis, target-vessel revascularization, and target-lesion revascularization were significantly higher in the paclitaxel-eluting vs the everolimus-eluting stent group.

"In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year," the researchers wrote.

The study was funded by Boston Scientific.

References

  1. Kaul U, Bangalore S, Seth A, et al; for the TUXEDO-India Investigators. Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes. N Engl J Med. 2015;doi:10.1056/NEJMoa1510188.
  2. Kaul U. Plenary Session XX. Late-Breaking Clinical Trials 3: Co-sponsored by JAMA. TUXEDO: A Prospective Randomized Trial of Paclitaxel-Eluting vs Everolimus-Eluting Stents in Diabetic Patients With Coronary Artery Disease. Presented at: TCT 2015; Oct. 11-15, 2015; San Francisco.
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