EuroPCR 2024: Elixir Medical’s Late-Breaking 12-Month Data Demonstrate Significant Improvement in Safety and Effectiveness of World’s First Site-Specific Antithrombotic Therapeutic Compared to DES
May 14 2024 - 9:15AM
Business Wire
—DESyne BDS Plus system with site-specific
antithrombotic therapeutic (TRx) significantly reduced the risk of
TLF versus conventional drug-eluting stent through 12-months—
—First site-specific antithrombotic therapeutic
with two anticoagulants and an anti-proliferative mTOR inhibitor
designed to reduce the burden of managing ischemic and thrombotic
risk in cardiovascular interventions—
Elixir Medical, a developer of transformative technologies to
treat cardiovascular and peripheral disease, today announced
significant positive 12-month clinical data from the DESyne BDS
Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus,
the world’s first triple drug-eluting coronary implant with
site-specific antithrombotic therapeutic (TRx) coating versus a
contemporary, durable polymer drug-eluting stent (DES). The data
demonstrated a statistically significant lower TLF rate with DESyne
BDS Plus than contemporary DES. The data were presented at a
late-breaking clinical session during the EuroPCR 2024 conference
in Paris.
“The current standard of care of combining oral antithrombotic
therapies continues to pose serious challenges, especially in
patients who are at high thrombotic risk and high bleeding risk, as
managing the tradeoff between ischemic and bleeding risks is
logistically unsustainable for healthcare providers and often
results in delay of essential treatment decisions,” said Alexandre
Abizaid, M.D., Ph.D., interventional cardiologist at Instituto do
Coração (InCor) in Sao Paulo, Brazil. “These exciting results from
the DESyne BDS Plus RCT demonstrate the sustained superiority in
safety and efficacy of DESyne BDS Plus compared to a standard of
care DES and underscore the potential for site-specific
anti-thrombotic therapeutic (TRx) as a promising solution that
effectively addresses the compromises we have to make between
bleeding and thrombosis when using systemic drug therapies.”
12-month clinical results demonstrated safety and efficacy of
DESyne BDS Plus:
- Significantly lower TLF rate of 2.1% for DESyne BDS Plus
compared to 9.3% for contemporary DES, p=0.03.
- No definite or probable stent thrombosis, cardiovascular death,
or target vessel myocardial infarction (TV-MI), were observed in
DESyne BDS Plus treated patients
Previously presented data found that the study’s primary
endpoint was met (pnon-inferiority<0.001); TLF at day three or
at hospital discharge, whichever came first, which was 0.0% for
DESyne BDS Plus treated patients versus 5.0% for patients treated
with the contemporary durable polymer DES.
DESyne BDS Plus has a bioresorbable coating containing three
drugs: two anticoagulants (rivaroxaban and argatroban) and an
antiproliferative mTOR inhibitor (sirolimus) designed for delivery
of site-specific antithrombotic therapeutic. The coronary implant
with TRx therapeutic is designed to reduce thrombotic risk while
eliminating the negative side effect of bleeding associated with
oral anti-thrombotic use and to effectively help address the
challenge of logistically managing ischemic and bleeding risk in
at-risk PCI patient populations.
“We are thrilled with the statistically significant 12-month
clinical outcomes of the TRx platform validating the improved
safety and effectiveness of site-specific TRx therapeutic for
coronary PCI treatment,” said Motasim Sirhan, CEO of Elixir
Medical. “Site-specific antithrombotic therapy can be a more
effective approach to addressing ischemic risk without the risk and
complications of bleeding associated with oral
anti-thrombotics.”
Coronary artery disease is the leading cause of death for men
and women in most racial and ethnic groups in the U.S.1 While PCI
has positively impacted mortality rates,2 procedure and device
related risks remain. Stent thrombosis after PCI is associated with
large territory myocardial infarction (MI) events and poor
outcomes, with death rates as high as 50% for early (<30 days)
thrombosis cases.3 Management of ischemic and thrombotic risk
requires medication adherence, but only 60% of patients are
adherent to their prescribed cardiovascular medications which can
lead to an increased risk of cardiovascular events or mortality by
20% or 35%, respectively.4 In addition, 3.5% of patients undergo
non-cardiac surgery within six months of PCI procedure requiring
careful management of thrombotic and bleeding risk by healthcare
providers.5
About the DESyne BDS Trial
The DESyne BDS Plus Randomized Clinical Trial (RCT) is a
prospective, multicenter, single-blind study evaluating the safety,
effectiveness, and performance of the DESyne BDS Plus Triple
Drug-Eluting Coronary Implant compared to DESyne X2 Drug-Eluting
Coronary Stent System in the treatment of de novo native coronary
artery lesions. The trial includes 202 patients across 14 sites in
Europe, New Zealand, and Brazil. An imaging subset of 58 patients
had angiographic and optical coherence tomography (OCT) assessment
completed in the first six months. Data collection will continue
through three years.
About TRx
TRx is the world’s first triple-drug site-specific
antithrombotic therapeutic using two anticoagulants (rivaroxaban
and argatroban) and an antiproliferative mTOR inhibitor, sirolimus.
The therapy was designed to address challenges associated with oral
anti-thrombotics requiring a compromise between ischemic and
bleeding risk, making it difficult and unsustainable for healthcare
providers to manage patient needs.
About Elixir Medical
Elixir Medical Corporation, a privately-held company based in
Milpitas, California, develops disruptive platforms to treat
coronary and peripheral artery disease. Our technologies have
multiple applications across the cardiovascular space capable of
delivering improved clinical outcomes for millions of patients.
Visit us at www.elixirmedical.com and on LinkedIn and X.
References:
- Heart Disease Facts | CdC.gov. (2023, May 15). Centers for
Disease Control and Prevention.
https://www.cdc.gov/heartdisease/facts.htm
- Liza Chacko, James P. Howard, Christopher Rajkumar, Alexandra
N. Nowbar, Christopher Kane, Dina Mahdi, Michael Foley, Matthew
Shun-Shin, Graham Cole, Sayan Sen, Rasha Al-Lamee, Darrel P.
Francis and Yousif Ahmad, Effects of Percutaneous Coronary
Intervention on Death and Myocardial Infarction Stratified by
Stable and Unstable Coronary Artery Disease: A Meta-Analysis of
Randomized Controlled Trials, Cardiovascular Quality and Outcomes.
2020
https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.119.006363
- Lawton et al. 2021 ACC/AHA/SCAI Coronary Revascularization
Guideline.
- Chen Chen, MD, 1 Xiaoqing Li, MD, 1 Yuhao Su, MD, 1 Zhigang
You, MD, PhD, 1 Rong Wan, PhD, 2 and Kui Hong, MD, PhD. Adherence
with cardiovascular medications and the outcomes in patients with
coronary arterial disease: “Real‐world” evidence. Clinical
Cardiology. September 18, 2022.
https://pubmed.ncbi.nlm.nih.gov/36116032/
- Smilowitz et al. Risks of Non-Cardiac Surgery Early after
Percutaneous Coronary Intervention. Am Heart J. 2019 November; 217:
64–71.
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