Four-year results from patient-level meta-analysis confirm safety profile of Philips Stellarex .035” low-dose drug-coated b...
November 07 2020 - 11:15AM
November 07, 2020
Meta-analysis of two major randomized controlled trials (RCTs)
show no difference in mortality between patients treated with the
Philips Stellarex drug-coated balloon (DCB) and those treated with
percutaneous 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 results of a patient-level meta-analysis that confirms the
safety profile of its Stellarex drug-coated balloon (DCB) at four
years. Including data from two major randomized controlled trials
(RCTs), the results show no difference in mortality between
patients treated with the Stellarex DCB and those treated with
percutaneous angioplasty (PTA), the current standard of care. The
meta-analysis, which represents the highest level of the evidence
pyramid, was presented at the virtual 2020 Vascular Interventional
Advances conference (VIVA20).
The meta-analysis found that over four years, there was no
significant difference in survival among patients treated with the
Stellarex DCB (85.7%) compared to those treated with PTA (85.6%).
The data includes two Stellarex RCTs: the ILLUMENATE EU RCT and the
ILLUMENATE Pivotal RCT, comprised of 589 patients in the U.S. and
Europe followed up to four years with a high compliance on vital
status data.
“The meta-analysis reinforces previously presented results from
the ILLUMENATE RCTs, demonstrating low mortality rates each year
through four years, with no difference in rates between the two
patient cohorts,” said Sean Lyden, MD, Chairman of the Department
of Vascular Surgery, Cleveland Clinic (U.S.), who presented the
data. Dr. Lyden is also co-Primary Investigator for the ILLUMENATE
Pivotal trial, one of the two RCTs included in the meta-analysis,
and a paid consultant to Philips. “This independent, patient-level
meta-analysis continues to provide consistent, long-term data for a
large group of patients.”
In addition to demonstrating no significant difference in
all-cause mortality between patients treated with the Stellarex DCB
and those treated with PTA (14.3% vs. 14.4%), the results of the
meta-analysis also show no difference in cardiovascular mortality
(3.6% vs. 4.0%) and non-cardiovascular mortality (10.8% vs.
10.9%).
“The results of this study confirm the safety and performance of
our unique Stellarex low-dose drug-coated balloon,” 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 in order to
help them make an informed decision on the optimal treatment for
each patient with peripheral arterial disease. Stellarex, with its
low drug dose and unique drug coating composition, 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, Stellarex .035”
DCB is unlike any other drug-coated balloon 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.
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 2019 sales of EUR 19.5 billion and
employs approximately 81,000 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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