Groundbreaking Randomized Controlled Trial Reports Excellent Clinical Outcomes Using CytoSorb® Intraoperatively in Heart Transplant Patients
CytoSorbents Corporation (NASDAQ: CTSO) reports statistically significant reductions in multiple organ failure and dysfunction in heart transplant patients using CytoSorb® blood purification. The groundbreaking randomized controlled trial (RCT) published in the European Society of Cardiology journal, ESC Heart Failure, showed that patients who received CytoSorb had better hemodynamic stability, lower rates of post-operative shock, shorter time on mechanical ventilation, lower rates of acute kidney injury, and shorter time in the ICU. The study also revealed similar rates of cardiac allograft rejection, 30-day mortality, and 1-year survival between the CytoSorb group and the control group.
Positive
Statistically significant reductions in multiple organ failure and dysfunction
Better hemodynamic stability and lower rates of post-operative shock
Shorter time on mechanical ventilation
Lower rates of acute kidney injury and need for renal replacement therapy
Shorter time in the ICU
No relevant removal of the anti-rejection drug mycophenolic acid (MPA)
Similar rates of cardiac allograft rejection, 30-day mortality, and 1-year survival between groups
No reported device-related adverse events during the study period
The recent findings from CytoSorbents Corporation's randomized controlled trial (RCT) have significant implications for the medical community, particularly in the field of cardiothoracic surgery. The use of CytoSorb blood purification technology during heart transplants has demonstrated a reduction in post-operative complications such as vasoplegic syndrome (VS), acute kidney injury (AKI) and the need for renal replacement therapy (RRT). The reduction in the median time on mechanical ventilation and ICU stays are particularly noteworthy, as these factors contribute to patient recovery and healthcare costs.
From a medical research perspective, the absence of device-related adverse events reinforces the safety profile of CytoSorb. However, it is crucial to consider the size and scope of the study. While a single-center RCT provides valuable insights, larger multi-center trials would be necessary to generalize these findings across diverse populations and settings. Furthermore, the long-term outcomes beyond the 1-year survival rate mentioned will be essential to evaluate the sustained efficacy and safety of the treatment.
From an economic standpoint, the use of CytoSorb therapy could potentially lead to a reduction in healthcare costs associated with heart transplants. Shorter ICU stays and reduced need for mechanical ventilation and RRT suggest a decrease in resource utilization, which is a significant driver of healthcare expenditures. Additionally, the lower incidence of AKI could translate into fewer long-term health complications and associated costs.
However, the economic impact must be weighed against the cost of the CytoSorb device itself. A cost-benefit analysis would be instrumental in determining the overall value proposition of incorporating CytoSorb into standard care protocols for heart transplants. Insurance providers and healthcare facilities will likely scrutinize such data to decide on reimbursement policies, which will ultimately influence the adoption rate of this technology.
From a surgical perspective, the improvements in hemodynamic stability and the reduced rates of vasoplegic syndrome are particularly compelling. These factors are critical during the perioperative period and can significantly impact patient outcomes. The study's findings suggest that CytoSorb could become an integral tool in managing complex heart transplant surgeries, especially in high-risk patients.
It is also reassuring to note that the use of CytoSorb did not lead to the removal of the anti-rejection drug mycophenolic acid (MPA), which is a concern with any extracorporeal therapy. The similar rates of cardiac allograft rejection between the CytoSorb group and the control group provide further confidence in the compatibility of this treatment with the standard post-transplant care regimen.
01/17/2024 - 07:15 AM
CytoSorb Blood Purification Results in Statistically Significant Reductions in Multiple Organ Failure and Dysfunction
PRINCETON, N.J., Jan. 17, 2024 (GLOBE NEWSWIRE) -- 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, reports on excellent outcomes from a groundbreaking randomized controlled trial (RCT) using CytoSorb® blood purification during heart transplant, recently published in the European Society of Cardiology journal, ESC Heart Failure .
As co-lead authors Drs. Endre Németh and Adam Soltesz from the Heart and Vascular Center at Semmelweis University, Budapest, Hungary explain, as more complex and higher risk patients become eligible for heart transplant, so does the risk of serious complications such as multiple organ failure, that not only is the second leading cause of death following heart transplant, but results in high costs due to protracted ICU and hospital stays. In particular, vasoplegic syndrome (VS), a form of circulatory failure or shock, is routinely seen in these patients and can cause worsened organ failure. In a prior observational study , CytoSorb was associated with the reduced severity of vasoplegia in heart transplant patients, in addition to other clinical benefits.
In this prospective, single-center, open-label RCT, 60 heart transplant recipients were randomly assigned to either receive intraoperative CytoSorb hemoadsorption or standard of care. Key statistically significant findings of the study were that the CytoSorb group, compared to the control group, had:
Better hemodynamic stability and lower rates of post-operative shock Patients in the CytoSorb group had lower median Vasoactive-Inotropic Scores (27.2 [14.6–47.7] vs. 41.9 [22.4–63.2], p =0.046) and Vasoplegic Syndrome rates (20.0% vs 48.0% control, p =0.028) The odds of early Vasoplegic Syndrome were 6.4 times lower in the CytoSorb group (p =0.029). Shorter median time on mechanical ventilation 25 [19–68.8] hours vs. 65 [23–287] hours in control, p =0.025 Lower rates of acute kidney injury (AKI) and need for renal replacement therapy (RRT) AKI: 36.7% vs. 76.0% control, p =0.004 Renal replacement therapy: 0% vs. 16.0% control, p =0.037 Shorter median time in the ICU 8.5 [8.0–10.3] days vs. 12 [8.5–18.0] days in control, p =0.022 No relevant removal of the anti-rejection drug mycophenolic acid (MPA) Similar rates of cardiac allograft rejection, 30-day mortality, and 1-year survival between groups There were no reported device-related adverse events during the study period Dr. Daniel Wendt, Vice President Medical – Cardiovascular at CytoSorbents stated, "Over the years, cardiothoracic surgeons have repeatedly observed the benefits of intraoperative CytoSorb blood purification in improved hemodynamic stability, reduced incidence and severity of vasoplegic shock, decreased incidence of organ dysfunction, reduced inflammatory responses, and favorable post-operative outcomes. Now, Nemeth, Soltesz, and colleagues have confirmed many of these observations in this rigorous and well-designed groundbreaking randomized controlled trial in orthotopic heart transplant patients. These vital and statistically significant clinical outcomes highlight the critical importance of CytoSorb in cardiothoracic surgery and are expected to be a catalyst for continued adoption, usage, and reimbursement in this arena. Also, on the heels of recent positive data in lung transplant using CytoSorb , these results continue to advance our pioneering role in the field of solid organ transplant in general."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation CytoSorb ® ticagrelor rivaroxaban FDA Emergency Use Authorization FDA Breakthrough Device Designations ticagrelor direct oral anticoagulants (DOAC) 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 $50 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™, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com www.cytosorb.com Facebook X
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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, statements about potential exposures resulting from our cash positions, 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, 2023, 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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U.S. Company Contact:
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What is the ticker symbol for CytoSorbents Corporation?
The ticker symbol for CytoSorbents Corporation is NASDAQ: CTSO.
What were the key findings of the randomized controlled trial (RCT) using CytoSorb® blood purification during heart transplant?
The key findings of the RCT were better hemodynamic stability, lower rates of post-operative shock, shorter time on mechanical ventilation, lower rates of acute kidney injury, and shorter time in the ICU among patients who received CytoSorb.
What were the rates of acute kidney injury (AKI) and need for renal replacement therapy (RRT) in the CytoSorb group?
The rates of AKI and need for RRT were lower in the CytoSorb group compared to the control group, with AKI at 36.7% vs. 76.0% in the control group and RRT at 0% vs. 16.0% in the control group.
What were the findings related to cardiac allograft rejection, 30-day mortality, and 1-year survival between the CytoSorb group and the control group?
The study revealed similar rates of cardiac allograft rejection, 30-day mortality, and 1-year survival between the CytoSorb group and the control group.
