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

Some of the device technologies discussed in the TCT 2020 late-breaking trial sessions. Top left, the  Medtronic Resolute Onyx stent was the first stent to receive FDA clearance for short duration dual-antiplatelet therapy, which was a big topic and subject of several sessions. Lower left, the Keystone TriGuard 3 TAVR embolic protection device did not demonstrate superiority over TAVR without use of embolic protection. Top right, the Abbott MitraClip. Acurate neo TAVR valve. #TCTconnect #TCT2020

Some of the device technologies discussed in the TCT 2020 late-breaking trial sessions. Top left, the Medtronic Resolute Onyx stent was the first stent to receive FDA clearance for short duration dual-antiplatelet therapy, which was a big topic and subject of several sessions. Lower left, the Keystone TriGuard 3 TAVR embolic protection device did not demonstrate superiority over TAVR without use of embolic protection. Top right, the Abbott MitraClip was the subject of two studies, including use to aid heart transplant patients. Bottom right, the Boston Scientific Acurate neo TAVR valve performed below the Sapien 3 and CoreValve Evolut.

Feature | TCT | October 29, 2020 | Dave Fornell, Editor
Here are some of the key takeaways from the late-breaking interventional cardiology and structural heart trials prese
TCT 2020 Late-breaking Study trial Presentations Announced. #TCTconnect #TCT2020 #TCT
Feature | TCT | October 29, 2020
October 29, 2020 — The late-breaking studies are one of the hallmarks of the annual...
Interventional cardiology and structural heart pioneer Martin Leon, M.D., is the name-sake of the new joint ACC-CRF Center for Cardiovascular Transformation. 

Interventional cardiology and structural heart pioneer Martin Leon, M.D., is the name-sake of the new joint ACC-CRF Center for Cardiovascular Transformation. 

News | TCT | October 14, 2020
October 14, 2020 — The American College of Cardiology (ACC) and the...
Videos | TCT | August 01, 2020
With COVID-19 forcing all medical conferences to go virtual in 2020,...
EchoPixel showed technology at TCT 2019 that creates live holograms in the cath lab from 3-D TEE imaging. It projects the holograms on a special display screen that does not require the user to wear 3-D glasses. The interventional cardiologist can use hand movements and a foot switch to move the image around without breaking the sterile field. It offers a new way to visualize catheters, device positioning and deployment for structural heart procedures. #TCT2019 #TCT #TCT19

EchoPixel showed technology at TCT 2019 that creates live holograms in the cath lab from 3-D TEE imaging. It projects the holograms on a special display screen that does not require the user to wear 3-D glasses. The interventional cardiologist can use hand movements and a foot switch to move the image around without breaking the sterile field. It offers a new way to visualize catheters, device positioning and deployment in structural heart procedures. (Photos by Dave Fornell)

Feature | TCT | November 04, 2019 | Dave Fornell, Editor
The latest in interventional cardiology clinical data and new device technologies were highlighted at the annual ...
TCT 2019 Late-breaking Presentations in the main arena. The top interventional cardiology studies of 2019. #TCT #TCT19 #TCT2019
Feature | TCT | October 11, 2019
The Cardiovascular Research Foundation (CRF) has announced the 12 late-breaking trials and 16 late-breaking science...
Videos | TCT | October 03, 2018
DAIC Editor Dave Fornell takes a tour of some of the most innovative new cardiovascular technology he found on the ex
cardiologist Ted Feldman, M.D., at TCT 2017. #TCT2018 #TCT #TCT18 TCT Late breaking trials, studies.
Feature | TCT | September 21, 2018
October 4, 2018 – The Cardiovascular Research Foundation (CRF) had 15 late-breaking trials and 12 late-breaking clini
Interventional cardiology, cath lab technology, TCT, transcatheter cardiovascular therapeutics. #TCT #TCT18 #TCT2018
Feature | TCT | September 14, 2018 | Dave Fornell, Editor
The volume of information attendees receive at the annual...