MONMOUTH
JUNCTION, N.J., Jan. 24,
2022 /PRNewswire/ -- CytoSorbents
Corporation (NASDAQ: CTSO), a leader in the treatment of
life-threatening conditions in the intensive care unit and cardiac
surgery using blood purification, highlights a new publication in
the peer-reviewed journal, Annals of Thoracic and Cardiovascular
Surgery, entitled "Hemoadsorption of Rivaroxaban
and Ticagrelor during Acute Type A Aortic Dissection Operations."
In this publication, Hassan et al. reported on the use of
intraoperative hemoadsorption using CytoSorbents' technology to
reduce perioperative bleeding complications in patients with acute
type A aortic dissection, a life-threatening condition with a
mortality rate of 1-2% per hour, who were either on the direct oral
anticoagulant (DOAC) rivaroxaban (Xarelto®, Janssen and
Bayer) or the antiplatelet drug ticagrelor
(Brilinta®, AstraZeneca) at the time of urgent on-pump
cardiac surgery.
- The authors completed a retrospective analysis of 171
consecutive patients undergoing urgent surgical repair for acute
type A aortic dissection between 2014 and 2020 and identified 21
patients (12.3%) who were either on rivaroxaban (n=9) or ticagrelor
(n=12).
- Among these 21 patients, 10 patients received intraoperative
hemoadsorption, and their operative and clinical outcomes were
compared with the 11 patients not treated with intraoperative
hemoadsorption.
- Baseline characteristics were generally comparable between the
two groups, however, hemoadsorption patients were older (mean age
75 vs. 62 years) and had higher perioperative risk based on the
calculated EUROSCORE II scale (17.1 vs. 10.6; higher score reflects
higher risk for complications and mortality).
- Although the operative techniques and duration on
cardiopulmonary bypass were similar between the two groups, total
operation time was significantly shorter in the hemoadsorption
group (286 ± 40 min vs. 348 ± 79 min, p=0.045), presumably due to
less time required to achieve hemostasis at the end of the
operation.
- Most importantly, intraoperative hemoadsorption (vs. without)
was associated with favorable clinical outcomes following urgent
type A aortic dissection surgery, including:
-
- Positive trend in lower 30-day mortality: 10% (1/10) vs. 27.3%
(3/11)
- Zero need for re-operations (vs. 18.2% without
hemoadsorption)
- Significantly lower mean 24-hour chest tube drainage, an
independent predictor of postoperative morbidity and mortality (482
± 122 ml vs. 907 ± 427 ml, p<0.001).
- Significantly fewer platelet transfusions (p=0.049)
- The above clinical benefits translated to shorter median ICU
length of stay in patients treated with hemoadsorption (4 days)
compared to those without (9 days).
Dr. Efthymios N. Deliargyris, Chief Medical Officer of
CytoSorbents stated, "This new publication extends the evidence for
clinical benefit with intraoperative antithrombotic removal using
our hemoadsorption technology beyond coronary artery bypass
grafting (CABG) and into additional complex cardiac operations,
such as acute type A dissection aortic surgery. All urgent
cardiac surgeries are complex and carry high risk for
complications, but as any cardiac surgeon will attest, operating in
the presence of antithrombotic drugs such as ticagrelor or DOACs
can result in significant bleeding complications which can
negatively impact patient outcomes and increase costs."
Dr. Deliargyris concluded, "These encouraging data, though from
a small single-center study, are consistent with the published
literature on the use of our technology to reduce bleeding
complications from cardiothoracic surgery in patients on
antithrombotic drugs. Furthermore, it validates our strategy
to include patients undergoing urgent aortic surgery in both the
STAR-T and STAR-D trials. We plan to incorporate these new
data in our recruiting and training efforts with study sites.
The U.S. STAR-T and STAR-D trials, evaluating the use of
DrugSorb™‑ATR for intraoperative removal of antithrombotic drugs
during urgent cardiothoracic surgery, are our top priorities.
We remain laser-focused and are dedicating all necessary
resources to drive enrollment completion of these two studies in
the next 12-18 months to support potential future FDA marketing
approval."
About CytoSorbents Corporation (NASDAQ:
CTSO)
CytoSorbents Corporation is a leader in the
treatment of life-threatening conditions in intensive care and
cardiac surgery using blood purification. Its flagship
product, CytoSorb®, is approved in the European
Union with distribution in more than 70 countries around the world
as an extracorporeal cytokine adsorber designed to reduce the
"cytokine storm" or "cytokine release syndrome" seen in common
critical illnesses that may result in massive inflammation, organ
failure and patient death. These are conditions where the risk of
death can be extremely high, yet few to no effective treatments
exist. CytoSorb is also being used during and after
cardiothoracic surgery to remove inflammatory mediators that can
lead to post-operative complications, including multiple organ
failure. More than 162,000 cumulative CytoSorb devices have
been utilized to date. CytoSorb was originally introduced
into the European Union under CE-Mark as a first-in-kind cytokine
adsorber. Additional CE-Mark label expansions were received
for the removal of bilirubin and myoglobin in clinical conditions
such as liver disease and trauma, respectively, and
both ticagrelor and rivaroxaban during
cardiothoracic surgery. CytoSorb has also received FDA
Emergency Use Authorization in the United States for use
in adult critically ill COVID-19 patients with imminent or
confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic
Removal System, which is based on the same polymer technology as
CytoSorb, has also been granted FDA Breakthrough
Designation for the removal of ticagrelor, as well as FDA
Breakthrough Designation for the removal of the direct oral
anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a
cardiopulmonary bypass circuit during urgent cardiothoracic
surgery. The Company has initiated two FDA approved pivotal
trials designed to support U.S. marketing approval of DrugSorb-ATR.
The first is the 120-patient, 20 center
STAR-T (Safe
and Timely Antithrombotic Removal-Ticagrelor)
randomized, controlled trial evaluating the ability of
intraoperative DrugSorb-ATR use to reduce perioperative bleeding
risk in patients on ticagrelor undergoing cardiothoracic surgery.
The second is the 120-patient, 25 center
STAR‑D (Safe
and Timely Antithrombotic Removal
- Direct Oral Anticoagulants) randomized, controlled trial,
evaluating the intraoperative use of DrugSorb–ATR to reduce
perioperative bleeding risk in patients undergoing cardiothoracic
surgery on direct oral anticoagulants, including apixaban and
rivaroxaban.
CytoSorbents' purification technologies are based on
biocompatible, highly porous polymer beads that can actively remove
toxic substances from blood and other bodily fluids by pore capture
and surface adsorption. Its technologies have received
non-dilutive grant, contract, and other funding of more
than $39.5 million from DARPA, the U.S. Department of
Health and Human Services (HHS), the National Institutes of Health
(NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S.
Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM),
Air Force Material Command (USAF/AFMC), and others. The
Company has numerous marketed products and products under
development based upon this unique blood purification technology
protected by many issued U.S. and international patents and
registered trademarks, and multiple patent applications pending,
including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™,
HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For
more information, please visit the Company's websites
at www.cytosorbents.com and www.cytosorb.com or
follow us on Facebook and Twitter.
Forward-Looking Statements
This press release
includes forward-looking statements intended to qualify for the
safe harbor from liability established by the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, but are not limited to, statements about our plans,
objectives, representations and contentions and are not historical
facts and typically are identified by use of terms such as "may,"
"should," "could," "expect," "plan," "anticipate," "believe,"
"estimate," "predict," "potential," "continue" and similar words,
although some forward-looking statements are expressed differently.
You should be aware that the forward-looking statements in this
press release represent management's current judgment and
expectations, but our actual results, events and performance could
differ materially from those in the forward-looking statements.
Factors which could cause or contribute to such differences
include, but are not limited to, the risks discussed in our Annual
Report on Form 10-K, filed with the SEC on March 9, 2021, as updated by the risks reported
in our Quarterly Reports on Form 10-Q, and in the press releases
and other communications to shareholders issued by us from time to
time which attempt to advise interested parties of the risks and
factors which may affect our business. We caution you not to place
undue reliance upon any such forward-looking statements. We
undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise, other than as required under the
Federal securities laws.
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Investor Relations Contact:
Terri Anne
Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation