PRINCETON, N.J., Oct. 12,
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 via its proprietary polymer adsorption
technology, announced the presentation of exciting new data on the
use of CytoSorb® in various cardiac surgery indications at the
36th European Association for Cardio-Thoracic Surgery
(EACTS) Annual Meeting last week in Milan, Italy.
During the main scientific session, Professor Matthias Thielmann - Dept. of Thoracic and
Cardiovascular Surgery, West-German Heart & Vascular Center,
University Duisburg-Essen, Germany
presented the "Effect of intraoperative hemoadsorption
therapy in acute infective endocarditis with confirmed Staph.
aureus bacteremia."
The incidence of infective endocarditis, or infection of a heart
valve, is increasing globally. Staphylococcal aureus endocarditis
(SAE) accounts for roughly a quarter to a third of all cases and is
a dreaded complication associated with intravenous drug abuse and
use of dirty needles, hospital-acquired infections, prosthetic
heart valves, and community acquired endocarditis. Importantly, SAE
is the most aggressive form of valvular infection and can lead to a
myriad of complications including rapid destruction of the valve,
heart failure, cytokine storm, florid septic shock, septic
embolization, and the highest mortality risk among all types of
infective endocarditis, even with surgical replacement of the heart
valve. CytoSorb is used in this patient population during open
heart surgery to control cytokine storm, reduce inflammation and
Staphylococcal toxins, and reverse shock.
- Study population: 130 consecutive patients with
confirmed SAE who underwent heart valve surgery at 2 leading
German Heart Centers between 01/2015
– 03/2022. Mean age (60.8 vs. 60.7, p=ns) and baseline risk
according to EuroScore II (12.0 vs. 11.9, p=ns) were nearly
identical in the two groups. Approximately 25% of patients had a
repeat cardiac operation while almost 20% were IV drug users.
- Study objectives: To compare clinical outcomes between
patients who underwent standard of care valve replacement surgery
(Control group; n=55) and patients who underwent standard of care
valve replacement surgery plus intraoperative hemoadsorption (HA)
with CytoSorb (n=75).
- Primary outcome: Postoperative vasopressor requirements
assessed by the Vasoactive-Inotropic Score (a well-established and
accepted measure of vasopressor support required to manage
hemodynamic instability) was significantly reduced in the CytoSorb
group at 6, 12, 24, 48 and 72 hours (p<0.02 for all), consistent
with improved hemodynamic stability after surgery
- Secondary outcomes: Sepsis-related mortality was
significantly reduced in the CytoSorb group (8.0% vs. 21.8%,
p=0.02), as was overall 30-day (17.3% vs. 32.7%, p=0.03) and 90-day
mortality (21.3% vs. 40%, p=0.03). This marked effect on mortality
translated into a Number Needed to Treat (NNT) of just 5 patients
to save a life.
The authors summarized the results as: "1) Mortality
following cardiac surgery in infective endocarditis, particularly
caused by S. aureus, is still high; 2) Intraoperative cytokine
adsorption leads to improved postoperative hemodynamics, 3)
Improved survival in patients treated by intraoperative adjunctive
hemoadsorption" and concluded that: "Hemoadsorption with
CytoSorb seems to be a safe and effective adjunctive therapy in
Staphylococcus aureus infective endocarditis during cardiac
surgery."
Dr. Daniel Wendt, Vice President
- Medical Affairs Cardiovascular at CytoSorbents, stated, "The
selection of this study for presentation in the main scientific
program highlights the importance of these findings. As these
results clearly demonstrate, CytoSorb can address some of the
biggest management challenges in these very high risk endocarditis
patients."
CytoSorbents also hosted a lunch symposium entitled,
"Hemoadsorption with CytoSorb in high-risk cardiac surgery
indications – new data" that drew approximately 150
attendees and was chaired by Professors Christophe Baufreton (Angers, France) and Piotr
Suwalski (Warsaw,
Poland). Key presentations included:
"Clinical benefits in patients undergoing heart
transplantation – results of a single center
RCT." Dr. Endre Németh (Budapest, Hungary) presented the results of
the first ever randomized, controlled trial (RCT) using CytoSorb
intraoperatively during cardiac transplantation.
- Study population: 55 patients were randomized 1:1 to
either standard of care (SOC) or SOC plus CytoSorb. Baseline
characteristics were well-balanced between the two groups,
including mean recipient age of 56 years in both arms and donor
heart age of approximately 10 years less. Approximately half of the
patients suffered from idiopathic cardiomyopathy and approximately
one third from ischemic cardiomyopathy. Both cardiopulmonary bypass
duration (SOC 129 [104-169] vs. SOC + CytoSorb 133 [116-165]
minutes, p=ns) and total ischemic time (SOC 173±41 vs. SOC +
CytoSorb 152±45 minutes, p=ns) were similar.
- Primary outcome: Need for vasopressors to support blood
pressure as measured by the Vasoactive Inotropic Score (VIS) was
significantly reduced by CytoSorb (p=0.046), driven by reductions
in both noradrenaline and vasopressin requirements. Importantly,
this resulted in significantly lower rates of vasoplegia or
vasodilatory shock (SOC 48% vs. SOC + CytoSorb 20%; 58% relative
risk reduction (RRR), p=0.028) and shorter overall duration of
vasopressor support (p=0.046).
- Secondary outcomes: All clinical secondary endpoints
evaluated in the trial were either similar between the two groups
or statistically superior with SOC + CytoSorb including less time
on mechanical ventilation (SOC 65 [23-287] vs. 25 [19-68.8] hours,
p=0.025), lower rates of postoperative acute kidney injury (SOC 76%
vs. SOC + CytoSorb 36.7%; RRR 52%, p=0.004) and fewer days in the
ICU (SOC 12 [8.5-18] vs. 8.5 [8-10.3] days, p=0.022). Importantly,
there were no differences in all rejection markers evaluated at 30
days, while there were 2 deaths in the SOC group and no deaths in
the CytoSorb group.
Based on these RCT data, the authors concluded that proactive
intraoperative CytoSorb use in patients undergoing heart
transplantation resulted in important improvements in clinical and
economic outcomes, including: 1) Significantly improved
postoperative hemodynamic stability with reduced severity and
duration of vasoplegia, 2) Significantly lower rates of
postoperative acute kidney injury, 3) Significantly shorter time on
postop mechanical ventilation, and 4) Significant reduction in ICU
stay.
"Removal of antithrombotic drugs to reduce bleeding
complications and costs in high urgency operations."
Professor Michael Schmoeckel
(Hamburg, Germany) presented
previously published data demonstrating significant bleeding
reductions with the intraoperative use of CytoSorb for
antithrombotic drug removal in 55 patients undergoing urgent
coronary artery bypass grafting (CABG) and 21 patients undergoing
urgent type A aortic dissection repair who were either on
ticagrelor or rivaroxaban at the Asklepios St. Georg Klinik in
Hamburg, Germany
- Key Outcomes: Among CABG patients, the use of CytoSorb
was associated with significant reductions in 24-hour chest tube
drainage (relative risk reduction [RRR] 60%; p=0.004), platelet
(RRR 67%; p=0.048) and red blood cell transfusions (RRR 67;
p=0.012) and need for re-operation (RRR 100%; p=0.0003). Total
operative time was also significantly reduced (RRR 15%; p=0.004)
and patients who underwent antithrombotic removal with CytoSorb
spent 2 fewer days in the ICU (RRR: 50%; p=0.014) and 5 fewer days
overall in the hospital (RRR 31%; p=0.024). Similar types and
magnitude of benefits were also observed in patients undergoing
antithrombotic removal during aortic dissection surgery, but due to
the smaller sample size, statistical significance was only achieved
for reduction in 24-hour chest tube drainage (RRR 47%, p<0.001)
and platelet transfusions (RRR 31%, p=0.049).
- Cost Benefit: A boot strap analysis on the 55 CABG
patients, investigating the budget impact of CytoSorb use for
antithrombotic removal, demonstrated CytoSorb to be a dominant
therapy resulting in both clinical benefit and also substantial
cost-savings. Specifically, each use of CytoSorb was associated
with median budget savings of approximately € 4,200 (including the
cost of the device), driven primarily by less operative time and
shorter ICU stays.
"CytoSorb in infective endocarditis patients – what can we
learn from recent data?" Professor Matthias
Thielmann (Essen, Germany)
followed his presentation in the main scientific session of the
conference by providing a summary of recently published data from
different studies at the West German Heart & Vascular Center,
highlighting the use of CytoSorb in cardiac surgery applications to
mitigate the harmful effects of surgery.
- Publication on "Intraoperative hemoadsorption in patients with
native mitral valve infective endocarditis" in 58 consecutive
patients (CytoSorb, n=30; Control, n=28) showed that CytoSorb led
to a significant reduction in the need for vasopressors, a reduced
incidence of postoperative sepsis (Control 39.2% vs CytoSorb 16.7%,
p=0.05), and a significant reduction in sepsis-related mortality
(Control 18% vs CytoSorb 0%, p=0.02) in this well-defined
population.
- Publication on "Extracorporeal cytokine adsorption: Significant
reduction of catecholamine requirement in patients with AKI and
septic shock after cardiac surgery" detailed a case series of 98
high-risk cardiac surgery patients who developed postoperative
acute kidney injury and sepsis, and were treated by postoperative
continuous renal replacement therapy (CRRT) plus 15 hours of
adjunctive hemoadsorption with CytoSorb. In this trial, that
involved the Department of Nephrology at the University of
Essen in a team-based,
patient-centric approach, patients demonstrated a rapid and
significant decrease of lactate levels and vasopressor
support.
- Publication on "Intraoperative hemoadsorption in high-risk
patients with infective endocarditis" evaluated a series of 70
high-risk patients undergoing cardiac surgery for infective
endocarditis. In a propensity-score matched comparison (35 vs. 35
patients), the SOFA-score normalized significantly faster over a
7-day period in the CytoSorb treated group, among other
benefits.
Professor Thielmann then commented on the results of the REMOVE
endocarditis trial and compared them to the latest data from the
University of Nuremberg and Essen
and concluded that patient selection in infective endocarditis is
crucial, especially since high-risk patients, such as those with
SAE, are likely to benefit most from adjunctive hemoadsorption
techniques. Professor Thielmann concluded by stating that CytoSorb
is the only new concept in the surgical treatment of infective
endocarditis in many years, and has been used routinely for this
indication at his institution.
Dr. Wendt added, "I was delighted to attend the annual EACTS
meeting in person this year and was impressed by my discussions
with so many highly-motivated and experienced cardiac surgeons and
intensivists from all over the world who are using CytoSorb during
and after cardiothoracic surgery. From Hamburg to Madrid, Budapest to Rome, and Warsaw to Paris, clinical adoption of CytoSorb is
rapidly increasing as cardiac surgeons recognize the significant
benefits of using hemoadsorption in their most challenging cases.
With more data coming from multiple investigator-initiated trials,
as well as our own company-sponsored studies, we anticipate that
this momentum will only grow stronger in the future. As a busy
academic cardiac surgeon, I had the opportunity to use CytoSorb in
my most challenging cases for many years and witnessed first-hand
its value in my practice. In my current role, my top priority
is to make our key enabling technology the new standard in cardiac
surgery around the world."
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents
concluded, "The new data presented at this year's EACTS conference
validate our conviction that our proprietary hemoadsorption therapy
is a "game-changing" intervention in cardiac surgery. The clinical
benefits ranging from reversing shock and stabilizing patients
postoperatively, to shorter ICU stays for heart transplant
patients, to significantly less bleeding in patients on
antithrombotic drugs undergoing high risk surgery, to reductions in
mortality in the sickest endocarditis patients, speak to the power
of our technology. These data support a robust clinical and
economic value proposition that directly translates to
significantly better outcomes and cost savings to heart centers
around the world. We remain laser-focused on our clinical efforts
to continue generating high quality evidence in cardiac surgery and
are committed to making our technology available to U.S. centers
with the execution of our currently ongoing pivotal STAR-T and
STAR-D trials under FDA Breakthrough Device Designation."
About CytoSorbents Corporation
(NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit and in
cardiac surgery through blood purification. Its lead product,
CytoSorb®, is approved in the European Union and distributed in 75
countries worldwide. It is an extracorporeal cytokine adsorber that
reduces "cytokine storm" or "cytokine release syndrome" in common
critical illnesses that can lead to massive inflammation, organ
failure and patient death. In these diseases, the risk of
death can be extremely high, and there are few, if any, effective
treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove inflammatory mediators that can
lead to postoperative complications, including multiple organ
failure. As of June 30, 2022,
more than 179,000 CytoSorb devices have been used
cumulatively. CytoSorb was originally launched in the
European Union under CE mark as the first cytokine adsorber.
Additional CE mark extensions were granted for bilirubin and
myoglobin removal in clinical conditions such as liver disease and
trauma, respectively, and for ticagrelor and rivaroxaban removal in
cardiothoracic surgery procedures. CytoSorb has also received
FDA Emergency Use Authorization in the
United States for use in adult critically ill COVID-19
patients with impending or confirmed respiratory failure. The
DrugSorb™-ATR antithrombotic removal system, based on the same
polymer technology as CytoSorb, also received two FDA Breakthrough
Device Designations, one for the removal of ticagrelor and another
for the removal of the direct oral anticoagulants (DOAC) apixaban
and rivaroxaban in a cardiopulmonary bypass circuit during urgent
cardiothoracic procedures. The company has initiated two
FDA-approved pivotal studies to support FDA marketing approval of
DrugSorb-ATR in the United States. The first is the
randomized, controlled STAR-T (Safe and Timely Antithrombotic
Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate
whether intraoperative use of DrugSorb-ATR can reduce the
perioperative risk of bleeding in patients receiving ticagrelor and
undergoing cardiothoracic surgery. The second study is the
STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral
Anticoagulants) randomized, controlled trial of 120 patients at 30
centers evaluating the intraoperative use of DrugSorb-ATR to reduce
perioperative bleeding risk in patients undergoing cardiothoracic
surgery and taking 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 approximately
$48 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, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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.
Please Click to Follow Us on Facebook and Twitter
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cytosorbents-reports-new-cardiac-surgery-data-with-cytosorb-at-the-european-association-for-cardio-thoracic-surgery-eacts-annual-meeting-301646926.html
SOURCE CytoSorbents Corporation