Five-year patient-level meta-analysis of ILLUMENATE EU RCT and Pivotal study results confirms safety profile of Philips Stell...
20 April 2021 - 05:25PM
Five-year patient-level meta-analysis of ILLUMENATE EU RCT and
Pivotal study results confirms safety profile of Philips Stellarex
.035” low-dose Drug-Coated Balloon
April 20, 2021
Stellarex is the only Drug-Coated Balloon (DCB) to consistently
demonstrate no difference in mortality every year through five
years when compared with percutaneous transluminal angioplasty
(PTA), the current standard of care
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced the five-year patient-level meta-analysis of two major
randomized controlled trials (RCTs). The findings, which represent
the highest level of the evidence pyramid [1], confirm the
long-term safety of the Philips Stellarex Drug-Coated Balloon
(DCB). The meta-analysis shows no difference in mortality at each
year through five years for patients treated with the Stellarex
low-dose DCB when compared with those treated with percutaneous
transluminal angioplasty (PTA), the current standard of care. The
meta-analysis was presented at the 2021 Charing Cross International
Symposium.
The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT meta-analysis
comprises approximately 600 patients in Europe and the U.S., and is
the largest homogenous patient data set of paclitaxel DCB RCTs with
five-year follow-up [2,3]. After five years, the meta-analysis for
the two studies shows no difference in survival rates, with 80.4%
for the Stellarex DCB arm and 80.4% for the PTA arm. The analysis
also demonstrates that the use of one or multiple Stellarex DCBs in
a patient is not a predictor of mortality. The meta-analysis has a
vital status follow-up compliance of over 90%.
“This meta-analysis confirms and reinforces the consistent and
durable long-term safety profile of the low-dose Stellarex DCB
through five years,” said William Gray, MD, FACC, FSCAI, and
President of the Lankenau Heart Institute, an investigator for the
Stellarex clinical trials who presented the results. “The results
are an important contribution to the long-term safety of
paclitaxel-coated devices.”
“Stellarex is the only paclitaxel DCB to consistently
demonstrate no difference in mortality every year through five
years compared to PTA in multiple RCTs and in a patient-level
meta-analysis,” said Chris Landon, Senior Vice President and
General Manager Image Guided Therapy Devices at Philips. “We are
committed to providing healthcare providers with accurate and
transparent data to help them make an informed decision on the
optimal treatment for each patient with peripheral arterial
disease. With its low drug dose and unique drug coating
composition, Stellarex is a logical choice for those who require
this option.”
Featuring Philips EnduraCoat technology, a unique coating
consisting of a polyethylene glycol excipient with amorphous and
crystalline paclitaxel particles dispersed in it, Philips
Drug-Coated Balloon – Stellarex .035” is unlike any other DCB for
the treatment of peripheral artery disease. EnduraCoat technology
provides efficient drug transfer and effective drug residency
coupled with high coating durability and minimal particulate loss,
thereby enabling a low therapeutic drug dose.
Philips’ Image Guided Therapy business provides complete
procedural solutions of systems, smart devices, disease-specific
software and services for minimally invasive procedures, helping
caregivers decide, guide, treat and confirm the right therapy for
each patient during their procedure.
[1]
https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-of-evidence.
[2] Katsanos et al. Risk of Death Following Application of
Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery
of the Leg: A Systematic Review and Meta‐Analysis of Randomized
Controlled Trials. JAHA, December 8, 2018.[3] Schneider et al.
Paclitaxel exposure: Long-term safety and effectiveness of a
drug-coated balloon for claudication in pooled randomized trials.
Catheterization & Cardiovascular Interventions, August 24,
2020.
For further information, please contact:
Mark GrovesPhilips Global Press OfficeTel.: +31 631 639
916E-mail: mark.groves@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: + 31 622
698 001E-mail: fabienne.van.der.feer@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health
technology company focused on improving people's health and
well-being, and enabling better outcomes across the health
continuum – from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. Headquartered in the Netherlands, the company is a
leader in diagnostic imaging, image-guided therapy, patient
monitoring and health informatics, as well as in consumer health
and home care. Philips generated 2020 sales of EUR 19.5 billion and
employs approximately 82,000 employees with sales and services in
more than 100 countries. News about Philips can be found at
www.philips.com/newscenter.
- Philips Stellarex low-dose drug-coated balloon
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