Breakthrough Clinical Results
CytoSorbents Corporation announced results from a real-world data analysis presented at EuroPCR 2025, showing that its CytoSorbents therapy significantly reduced bleeding complications in urgent coronary artery bypass grafting (CABG) patients taking ticagrelor who hadn't completed the recommended drug washout period. The study compared patients who received the CytoSorbents device during surgery to a control group. The device group experienced statistically significant reductions in severe bleeding, large transfusion events, and the need for re-operations to control bleeding. No device-related adverse events were reported. These findings support the routine use of CytoSorbents' device to address the unmet medical need of patients on blood thinners requiring urgent cardiac surgery.
Key Highlights
- Statistically significant reduction in severe bleeding complications in urgent CABG patients on ticagrelor.
- Reductions in BARC-4 severe bleeding (10.7% vs. 33% control), large transfusion events (6% vs. 27% control), and re-operations for bleeding (4% vs. 9.6% control).
- No device-related adverse events reported.
- Data supports routine use of CytoSorbents' device in urgent CABG patients on ticagrelor.
Incidence and Prevalence
Global Incidence and Prevalence of Coronary Artery Bypass Grafting (CABG)
Based on the available information, there is no data provided regarding the latest estimates of incidence and prevalence of Coronary Artery Bypass Grafting (CABG) on a global basis from PubMed sources.
The context does indicate that there exists research on various aspects of CABG procedures, including:
- Cost analysis of CABG procedures
- Risk factors for stroke after CABG
- Comparisons between off-pump versus on-pump CABG techniques
- Long-term results of CABG with arterial grafts
- Adverse event rates while patients await CABG
- Graft patency rates following procedures
- Survival outcomes after CABG
- Reoperation for aortic bioprosthesis dysfunction
However, specific global epidemiological data about CABG incidence and prevalence is not present in the provided context.
Risk Factors and Comorbidities
Risk Factors and Comorbidities for CABG
Top Risk Factors
Based on the available context, the top risk factors for Coronary Artery Bypass Grafting (CABG) include:
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Smoking (83.1%), hypercholesterolaemia (80.2%), and hypertension (30.4%) are identified as the top three major reversible risk factors for patients with coronary heart disease who underwent CABG.
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Older age, diabetes, renal dysfunction, and reduced contractility of the left ventricle are risk factors for complications following CABG, especially in emergency cases with uncontrolled heart failure, cardiogenic shock, or ongoing infarction.
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Not being on statin (OR 3.54, P=0.047) and history of stroke or peripheral vascular disease (PVD; OR 3.5, P=0.034) are identified as risk factors for coronary intervention.
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Chronic obstructive pulmonary disease (COPD) is identified as the most common preoperative risk factor for CABG, with BMI >30 Kg/m and diabetes associated with risk of superficial skin dehiscence.
Top Comorbidities
The most frequently mentioned comorbidities associated with CABG patients include:
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Seven comorbidities were often coded as complications in CABG patients:
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Renal disease (13%)
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Recent myocardial infarction (15%)
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Peptic ulcer disease (15%)
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Congestive heart failure (17%)
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Cerebrovascular disease (26%)
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Hemiplegia (34%)
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Severe liver disease (35%)
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Gender differences are notable, with women undergoing CABG more frequently having:
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Hypertension (47% vs 33% in men)
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Diabetes mellitus (21% vs 10% in men)
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Family history of premature coronary heart disease (49% vs 31% in men)
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Postoperative major morbidity complications in CABG patients include:
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Cerebrovascular accident (2.5%)
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Mediastinitis (1.2%)
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Acute renal failure (5.6%)
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Cardiovascular failure (5.6%)
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Respiratory failure (0.9%)
Recent Studies
Recent Studies on Coronary Artery Bypass Grafting (CABG)
Study on Access-Site Choice for CABG Patients
A recent study examined access-site choice and outcomes for CABG patients undergoing coronary catheterization in different clinical settings. This study included 1206 consecutive CABG patients undergoing coronary angiography and intervention.
Intervention
The study evaluated transradial access versus transfemoral access for coronary catheterization in post-CABG patients.
Key Safety Outcomes
- Access-site complications were higher with femoral access (4.3%) compared to radial access (1.6%), p<.01
- Short-term mortality (30-day) was higher with femoral access (6.8%) compared to radial access (2.0%)
- Long-term mortality was higher with femoral access (hazard ratio 3.52, 95% confidence interval 1.84-6.70, p<.001)
- Length of hospital stay was longer in the femoral access group (5.3 ± 7.2 days vs 3.7 ± 5.1 days, p<.001)
Key Efficacy Outcomes
- Radial access was used in 63.1% of patients (753 patients) versus femoral access in 36.9% (442 patients)
- During the study period, femoral artery utilization dropped from 55.2% to a minimum of 28.2% per year (p<.01)
- Radial access was found to be favorable even in complex CABG patients
- Predictors for femoral access included short stature (odds ratio 1.62, p<.01), peripheral artery disease (odds ratio 1.42, p=.04), CPR (odds ratio 4.17, p<.001), STEMI (odds ratio 2.56, p=.01), and coexisting LIMA/RIMA bypass grafts (odds ratio 2.67, p<.001)
Study on CABG vs. PCI vs. Medical Therapy
Another study compared CABG, Percutaneous Coronary Intervention (PCI), and Medical Therapy (MT) for Acute Coronary Syndrome (ACS) patients.
Intervention
The study compared three interventional approaches: CABG, PCI, and MT for ACS patients.
Key Outcomes
- Study measured Health-Related Quality of Life (HRQOL) using EQ-5D-3L and visual analog scale (VAS)
- Study included 310 patients (CABG: n=128, PCI: n=139, MT: n=43)
- CABG group showed significantly greater HRQOL improvement compared to PCI and MT after 12 months
- CABG had higher annual total cost ($7327/patient) compared to PCI ($5225/patient) and MT ($2278/patient)
- Conclusion: CABG provides better quality of life despite being more difficult and expensive than PCI and MT
Drug used in other indications
CytoSorbents Device Clinical Trials Beyond CABG
The CytoSorbents device is being trialed for multiple indications beyond Coronary Artery Bypass Grafting (CABG), including:
- Right Ventricular Failure (RVF) after major cardiac surgery, including orthotopic heart transplantation and left ventricular assist device implantation
- Advanced heart failure requiring major cardiac surgery
Intervention Models
The clinical trials for these indications employ several intervention approaches:
- Double-blind randomized controlled trials with stratification by assigned surgery and key preoperative prognostic features
- Continuous treatment beginning at the time of separation from cardiopulmonary bypass with continuation into the intensive care unit stay
- Comparison of inhaled epoprostenol (iEPO) versus inhaled nitric oxide (iNO) as treatments
Trial Design for RVF and Heart Failure
In the specific trial examining RVF and heart failure, the following elements were included:
- Primary outcome measured as composite RVF rate defined by specific criteria for each operation type
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Secondary outcomes included:
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Mechanical ventilation duration
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Hospital and ICU length of stay
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Acute kidney injury development
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Mortality at 30 days, 90 days, and 1 year after surgery
- An equivalence margin of 15 percentage points was prespecified for between-group RVF risk difference