News | Stents | October 22, 2015

LEADERS FREE Trial Supports Polymer-free Drug-coated Stent for High Bleeding Risk Patients

BioFreedom DCS with one-month dual antiplatelet therapy regimen offers treatment option for those normally excluded from stent and drug trials

October 22, 2015 — Results from the LEADERS FREE trial found that a polymer-free drug-coated stent (DCS) was superior to a bare-metal stent (BMS) in high-bleeding-risk patients treated with one month of dual antiplatelet therapy (DAPT). It was the first randomized clinical trial dedicated to this particular patient population.  

Findings from the study were presented last week at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF). Study results were also published in the New England Journal of Medicine.

Patients at high risk of bleeding during percutaneous coronary intervention (PCI) are mostly excluded from device and antiplatelet therapy trials. Current recommendations for high-risk patients are one month of DAPT after BMS implantation and a “shortened” DAPT regimen after DES. LEADERS FREE examined the use of one month of DAPT for both types of stents, specifically studying the BioFreedom DCS from Biosensors International, which uses stent surface modification (rather than a drug delivery polymer) to elute lipophilic drug biolimus A9.

The prospective double-blind randomized study enrolled 2,466 patients with high bleeding risk during PCI. Patients were randomized 1:1 to receive a DCS (n=1,221) or BMS (n=1,211). Superiority for the primary safety endpoint (composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year post-procedure) was met with 112 (9.4 percent) for DCS and 154 (12.9 percent) for BMS. [Risk difference -3.6 percent (95 percent CI -6.1 percent to -1 percent), HR 0.71, (95 percent CI = 0.56 – 0.91), p < 0.0001 for non-inferiority and p = 0.005 for superiority].

The results for the primary efficacy endpoint of clinically-driven TLR at one year were 5.1 percent for DCS versus 9.8 percent for BMS. [Risk difference -4.8 percent (95 percent CI = -6.9 percent to -2.6 percent), HR 0.50, (95 percent CI = 0.37 – 0.69), p<0.001 for superiority].

“Patients who have a high risk of bleeding during PCI are often excluded from stent and drug trials but constitute a rapidly growing proportion of PCI candidates and they suffer high event rates,” said lead investigator Philip M. Urban, M.D., director of interventional cardiology at La Tour Hospital in Geneva, Switzerland. “The LEADERS FREE trial clearly showed that a drug-eluting stent combined with a one-month-only DAPT course was both significantly safer and more effective than a bare-metal stent in this subset of patients.”

The LEADERS FREE trial was funded by Biosensors Europe Ltd. Urban is a paid consultant for Biosensors Europe Ltd.

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...