News | Stents Drug Eluting | October 23, 2015

Everolimus-Eluting Stents Superior to Paclitaxel Stents in Indian Diabetic Patients

TUXEDO trial finds negative outcomes increase at one year with paclitaxel-eluting stents

TUXEDO trial, diabetic patients, drug-eluting stents, everolimus, paclitaxel, TCT 2015

Image courtesy of Abbott Vascular

October 23, 2015 — Results of the TUXEDO trial, designed to compare two types of stents in diabetic patients, found paclitaxel-eluting stents failed to meet non-inferiority criterion compared to everolimus-eluting stents for the primary endpoint of target-vessel failure at one year.

Findings from the trial were reported at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF), and published in the New England Journal of Medicine.

The optimal drug-eluting stent for coronary artery disease in a diabetic population has often been debated, with contradictory results from past studies comparing paclitaxel-eluting stents versus stents eluting rapamycin analogues (sirolimus, zotarolimus or everolimus). In the absence of an adequately powered study to assess clinical outcomes, a definitive conclusion has not yet been found.

In this investigator-initiated study, 1,830 patients with diabetes mellitus and coronary artery disease undergoing percutaneous intervention at 46 centers in India were randomly assigned to receive either a paclitaxel-eluting stent or everolimus-eluting stent in a non-inferiority trial. The primary endpoint was target-vessel failure defined as a composite of cardiac death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization at one-year follow-up.

In this trial, paclitaxel-eluting stents did not meet the non-inferiority criterion for target-vessel failure when compared to everolimus-eluting stents at one year (5.6 percent vs. 2.9 percent; relative risk=1.89; 95 percent CI=1.20 to 2.99; risk difference=2.7 percent; 95 percent CI=0.78 percent to 4.48 percent; Pnoninferiority=0.38). Notably, there was a significantly higher one-year rate of target-vessel failure (P=0.005), myocardial infarction (3.2 percent vs. 1.2 percent, P=0.004), stent thrombosis (2.1 percent vs. 0.4 percent, P=0.002), target-vessel revascularization (3.4 percent vs. 1.2 percent; P=0.002) and target-lesion revascularization (3.4 percent vs. 1.2 percent; P=0.002) in the paclitaxel-eluting stent group compared with the everolimus-eluting stent group.

“In patients with diabetes and coronary artery disease, paclitaxel-eluting stents were inferior to everolimus-eluting stents for the primary outcome of target-vessel failure and resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis and target-vessel revascularization at one year. Everolimus-eluting stents were superior to paclitaxel-eluting stents for several end points including target-vessel failure, myocardial infarction, and stent thrombosis,” said lead investigator Upendra Kaul, M.D. Kaul is executive director and dean, cardiology at the Fortis Escorts Heart Institute and Fortis Vasant Kunj in New Delhi, India.

“The TUXEDO trial supports the efficacy and safety of limus-eluting stents over paclitaxel-eluting stents 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,” Kaul said.

The TUXEDO trial was an investigator initiated study sponsored by Boston Scientific Corp. and a commitment to ensure consistent availability of the Xience Prime stent for the trial was provided by Abbott Vascular. Kaul reported research grant and lecture fees from Boston Scientific and lecture fees from Abbott Vascular.

For more information: www.tctconference.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init