Poly 2-methoxyethyl Acrylate Research Articles

Flow diverter surface modifications for aneurysm treatment: A review of the mechanisms and data behind existing technologies.

Flow diversion (FD) has become a mainstay treatment for large wide-necked aneurysms. Despite excellent safety and efficacy, the risk of thromboembolic complications necessitates the use of dual antiplatelet therapy (DAPT). The use of DAPT makes hemorrhagic complications of stenting carry high morbidity and mortality. Additionally, DAPT usage carries a risk of "nuisance" complications that do not directly impact intracranial circulation but need to be managed nonetheless. To circumvent this issue, the most recent generation of flow diverters have undergone surface modification with various compounds to confer blood compatibility to limit clotting and thrombosis. While these newer generation flow diverters are marketed to enhance ease of deployment, the goal is to eventually facilitate single antiplatelet use with flow diverter treatment. This generation of FDs have potential to expand indications beyond unruptured wide-necked aneurysms to include ruptured intracranial aneurysms without the necessity of DAPT. Currently, no comprehensive review details the molecular mechanisms and pre-clinical and clinical data on these modifications. We seek to fill this gap in the literature by consolidating information on the coating technology for four major FDs currently in clinical use-PipelineTM Flex and Vantage Shield TechnologyTM, FREDTMX, p48/64 hydrophilic coating, and Acandis Dervio® 2heal-to serve as a reference guide in neurointerventional aneurysm treatment. Although the Balt silkTM was one of the first FDs, it is uncoated, thus we will not cover this device in our review. A literature review was performed to obtain information on each coating technology for the major flow diverters currently on the market using international databases (PUBMED, Embase, Medline, Google Scholar). The search criteria used the keywords for each coating technology of interest "phosphorylcholine," "poly 2-methoxyethyl acrylate," "hydrophilic polymer coating," and "fibrin-heparin" Keywords related to the device names "Pipeline Shield," "Pipeline Shield with Flex Technology," "FRED," "FREDX," "p64," "p64-HPC," "Derivo 2heal" were also used. Studies that detailed the mechanism of action of the coating, any pre-clinical studies with surface-modified intravascular devices, and any clinical retrospective series, prospective series, or randomized clinical trials with surface-modified devices for aneurysm treatment were included.

Evaluation of the antithrombogenicity of poly-2-methoxyethylacrylate-coated catheters.

The blood compatibility of indwelling intravascular catheters is facilitated by the use of antithrombogenic materials. Heparin has typically been used for this purpose; however, since heparin-coated catheters are considered combination products, difficulties meeting the relevant Food and Drug Administration safety recommendations have disrupted commercialization. Other issues include coating durability and the occurrence of heparin-induced thrombocytopenia. Polymer coatings are a potential alternative; however, polymer antithrombogenicity in circulating human blood has yet to be demonstrated. The present study aimed to establish the ex vivo antithrombogenicity of a poly-2-methoxyethylacrylate (PMEA) polymer coating applied to a central venous catheter using an artificial human blood circulation system. The present study used an artificial human blood circulation system to conduct an ex vivo evaluation of the antithrombogenicity of poly-2-methoxyethylacrylate (PMEA)-coated catheters. Human blood samples obtained from volunteer donors were loaded into a circulation system fitted with either a PMEA-coated or uncoated catheter. After 3-h, the catheter was removed and examined using scanning electron microscopy. Protein adsorption on the catheter surface was investigated by shredding the catheter that had contacted the blood inside the circulation system and immersing the pieces in 1 mL of 0.5 N NaOH for 2 days. The amount of protein in the 0.5 N NaOH was determined according to the Lowry method. Adherent fibrin, which forms a sheath on the catheter surface, was observed on uncoated, but not PMEA-coated catheters. Furthermore, the amount of protein adsorption was significantly less with PMEA-coated than uncoated catheters (p = 0.043). The present findings demonstrated the antithrombogenicity of PMEA-coated catheters in circulating human blood.

Assessment of the Antithrombogenicity of a Poly-2-Methoxyethylacrylate-Coated Central Venous Port-Catheter System.

The purpose of this study was to evaluate the antithrombogenic effects of poly-2-methoxyethylacrylate (PMEA) coating applied to the internal surfaces of the port-catheter system to prevent thrombotic occlusion. PMEA coating was applied to the inner surfaces of the entire system, including the chamber, catheter, and connecting stem. PMEA-coated and uncoated port-catheter systems were each filled with fresh human blood for 1 or 3h and then flushed with saline. Volumes of residual thrombi in the system and protein in the catheter were then compared. Saline flushing of the PMEA-coated port-catheter system expelled all visually recognizable thrombi, leaving no unremovable adhesions. In contrast, the uncoated port showed thrombi adherent to the inner surfaces and incomplete expulsion with flushing. Mean (± standard deviation) residual thrombus mass was significantly lower in PMEA-coated port-catheter systems (20.5 ± 6.2mg) than in uncoated systems (230.3 ± 92.5mg; p < 0.01). Mean residual protein was likewise significantly lower in PMEA-coated systems (20.5 ± 6.2mg) than in uncoated systems (230.3 ± 92.5mg; p < 0.01). PMEA coating on a central venous port-catheter system decreased accumulation and facilitated flushing of thrombi from the system by flushing, as compared with the uncoated system. PMEA-coated central venous port-catheter systems appear relatively antithrombotic compared to uncoated systems.

Poly-2-methoxyethylacrylate-coated cardiopulmonary bypass circuit can reduce transfusion of platelet products compared to heparin-coated circuit during aortic arch surgery.

Several coating techniques for extracorporeal circulation have been developed to reduce the systemic inflammatory response during cardiopulmonary bypass (CPB). We compared the clinical effectiveness and biocompatibility of poly-2-methoxyethylacrylate (PMEA)- and heparin-coated CPB circuits in total aortic arch replacement (TAR) with the prolonged use of the bypass technique. Twenty patients who underwent elective TAR were divided randomly into two equal groups: group P (n=10) to use PMEA-coated circuits and group H (n=10) to use heparin-coated circuits. Clinical outcomes, hematological variables, and acute phase inflammatory response were analyzed perioperatively. Demographic, CPB, and clinical outcome data were similar for both groups. Hemoglobin and platelet count showed similar time-course curves. However, the amount of platelet products transfused intraoperatively was significantly larger in group H (group P 26.0±7.0units; group H 33.0±6.7units, p=0.04). Total protein, and albumin levels were significantly higher in group P during and after the operation (total protein, p=0.04; albumin, p=0.02). The use of PMEA-coated circuit is associated with retainment of perioperative plasma proteins levels and may help to reduce transfusion of platelet products in TAR in comparison with the heparin-coated circuit.

Multi‐Modal, Surface‐Focused Anticoagulation Using Poly‐2‐methoxyethylacrylate Polymer Grafts and Surface Nitric Oxide Release

This study examines platelet adhesion on surfaces that combine coatings to limit protein adsorption along with “anti‐platelet” nitric oxide (NO) release. Uncoated and poly‐2‐methoxyethylacrylate (PMEA) coated, gas permeable polypropylene (PP) membranes were placed in a bioreactor to separate plasma and gas flows. Nitrogen with 100/500/1000 ppm of NO was supplied to the gas side as a proof of concept. On the plasma side, platelet rich plasma (PRP, 1 × 108 cell/mL) was recirculated at low (60)/high (300) flows (mL/min). After 8 hours, adsorbed platelets on PP was quantified via a lactate dehydrogenase assay. Compared to plain PP, the PMEA coating alone reduced adsorption by 17.4 ± 9.2% and 29.6 ± 16.6% at low and high flow (p &lt; 0.05), respectively. NO was more effective at low plasma flow. At 100 and 500 ppm of NO, adsorption fell by 37.9 ± 6.1% and 100 ± 4.7%, (p &lt; 0.001), on plain PP. At high flow with 100, 500, and 1000 ppm of NO, adsorption reduced by 17.9 ± 17.8%, 46.4 ± 23.2%, and 100 ± 4.8%, (p &lt; 0.001), respectively. On PMEA‐coated PP with only 100 ppm, adsorption fell by 69.7 ± 6.8 and 65.6% ± 16.9%, (p &lt; 0.001), at low and high flows respectively. Therefore, the combination of an anti‐adsorptive coating with NO has great potential to reduce platelet adhesion and coagulation at biomaterial surfaces.

The effect of CD47 modified polymer surfaces on inflammatory cell attachment and activation

CD47 is a transmembrane protein that is a marker of “self”. CD47 binding to its cognate receptor in leukocytes and macrophages, signal-regulatory protein alpha (SIRPα), causes inhibition of inflammatory cell attachment. We hypothesized that immobilization of recombinant CD47 on polymeric surfaces would reduce inflammation. Recombinant CD47 was appended to polyvinyl chloride (PVC) or polyurethane (PU) surfaces via photoactivation chemistry. Cell culture studies showed that CD47 immobilization significantly reduced human neutrophil (HL-60) and human monocyte derived macrophage (MDM) (THP-1) attachment to PVC and PU respectively. A neutralizing antibody, directed against SIRPα, inhibited THP-1 and HL-60 binding to PU and PVC surfaces respectively. This antibody also increased the level of SIRPα tyrosine phosphorylation, thereby indicating a direct role for SIRPα mediated signaling in preventing inflammatory cell attachment. Studies using human blood in an ex vivo flow-loop showed that CD47 modified PVC tubing significantly reduced cell binding and neutrophil activation compared to unmodified tubing or poly-2-methoxy-ethylacrylate (PMEA) coated tubing. In ten-week rat subdermal implants, CD47 functionalized PU films showed a significant reduction in markers of MDM mediated oxidative degradation compared to unmodified PU. In conclusion, CD47 functionalized surfaces can resist inflammatory cell interactions both in vitro and in vivo.

Miniaturized biocompatible cardiopulmonary bypass for the Fontan procedure

Postoperative inflammatory response and perioperative systemic edema are the risks of failed Fontan circulation. We evaluated the efficiency of the miniaturized, poly-2-methoxyethylacrylate (PMEA)-coated cardiopulmonary bypass (CPB) circuit, which we devised in 2003, in the Fontan circulation. Thirty-seven patients who underwent the Fontan procedure between March 1996 and December 2006 were divided into two groups: one consisting of patients with a priming-volume >250 m on uncoated conventional bypass (group C; n = 20), and one consisting of those with miniaturized (<200 ml) and PMEA-coated circuits (group M; n = 17). We compared the body weight gain (%BWG), minimum platelet count, maximum postoperative C-reactive protein (CRP), and minimum hematocrit (Hct) levels during the operation, maximum white blood cell (WBC) count, and postoperative pleural effusion, between the two groups. Stepwise multiple logistic regression analyses were used to investigate the most affecting factors. The %BWG and CRP levels were significantly lower in group M (P = 0.047 and P = 0.012, respectively). The minimum platelet count was significantly higher in group M (P = 0.012). There were no significant differences in postoperative pleural effusion, minimum Hct, or maximum WBC. The miniaturized biocompatible CPB system reduced perioperative inflammatory responses.

Poly-2-methoxyethylacrylate-coated bypass circuits reduce activation of coagulation system and inflammatory response in congenital cardiac surgery

Surface-coated cardiopulmonary bypass (CPB) has been shown to have excellent biocompatibility during cardiac surgery in adults, but there have been only a few reports demonstrating the efficacy of this coating for congenital cardiac surgery. We tested the efficacy of poly-2-methoxyethylacrylate (PMEA) coating for CPB circuits in congenital cardiac surgery. Eleven operative cases of ventricular septal defect were studied: group C (control: no coating, n = 5) and group P (PMEA coating, n = 6). The platelet count and beta-thromboglobulin (beta TG), fibrinogen (FBG), thrombin-antithrombin complex (TAT), and neutrophil elastase levels were measured during the operation. Postoperative chest tube drainage was analyzed and the surface of the artificial lung was observed with an electron microscope. Elevation of TAT and neutrophil elastase was suppressed in group P (P < 0.05). Observation of the artificial lung surface using an electron microscope clearly revealed fewer blood cells were adherent to the surface in group P. The FBG level and postoperative bleeding were relatively lower in group P, but there were no significant differences between groups. The platelet count and beta TG level were the same in both groups. We concluded that the PMEA-coated circuit reduces activation of the coagulation system and the inflammatory reaction in pediatric cardiac surgery.

Interaction of plasma proteins with commercial protein repellent polyvinyl chloride (PVC): a word of caution

Protein adsorption onto polymers remains a problem. In recent years, several protein-repellent PVC tubings have been developed. Although several studies report the interaction between plasma coagulation proteins and PVC, few address the interaction with other plasma proteins. Two commercial brands of untreated medical grade PVC tubing, phosphorylcholine-coated PVC tubing, triblock-copolymer (polycaprolactone-polydimethylsiloxane-polycaprolactone)-treated PVC tubing and poly-2-methoxyethylacrylate (PMEA)-coated tubing were exposed for 60 minutes to human plasma. A broad spectrum of plasma proteins was found on all tubing. The adsorbed albumin to total protein ratio is lower than the similar ratio in plasma while alpha1 and alpha2 globulins are over-represented in the protein spectrum. On PMEA tubing, not only alpha globulins, but also beta and gamma globulins, are found in high concentrations in the adsorbed protein. PMEA tubing and uncoated PVC tubing of brand B had a higher amount of protein adsorbed compared against all other tubing (p < 0.05). There were no statistical differences in protein adsorption between the triblock-copolymer-treated tubing, the phosphorylcholine-coated tubing and the uncoated PVC tubing of brand A. The average thickness of the protein layer was 23 nm. Plasma protein adsorption still exists on uncoated and protein-repellent tubing and can initiate a systemic inflammatory reaction.

Biocompatibility of Heparin-Coated Cardiopulmonary Bypass Circuits in Coronary Patients With Left Ventricular Dysfunction Is Superior to PMEA-Coated Circuits

Several coating techniques for extracorporeal circulation have been developed to diminish the systemic inflammatory response during cardiopulmonary bypass (CPB). The aim of this study was to evaluate the clinical effectiveness and biocompatibility of heparin-coated and poly-2-methoxyethylacrylate (PMEA)-coated CPB circuits on coronary patients with left ventricular systolic dysfunction. Thirty-six patients who underwent elective coronary artery bypass grafting were divided into two equal groups: group H (n = 18), heparin-coated; group P (n = 18), PMEA coated. Clinical outcomes, hematologic variables, cardiac enzymes, malondialdehyde (MDA), and acute phase inflammatory response (including myeloperoxidase (MPO), catalase, hsCRP, and IL-8) were analyzed perioperatively. Demographic, CPB, and clinical outcome data were similar for both groups. Plasma fibrinogen, total protein, albumin, and platelet count decreased, neutrophil count, MDA, IL-8, MPO, and catalase levels increased during CPB. During CPB, MPO and catalase values were significantly higher in group P (p = 0.02 and p = 0.01) and postoperative MDA concentration was lower in group H (p = 0.03). Platelet counts were better preserved in group H during and after CPB but neutrophil count and IL-8 level did not differ between the groups. Postoperative total protein, albumin, and fibrinogen levels were higher in group H (p < 0.05). The postoperative first day levels of troponin-I, CK-MB, and CRP increased in both groups without any significant differences between the groups. Heparin-coated circuit provided better suppression of perioperative inflammatory markers and exhibited more favorable effects on hematologic variables than PMEA-coated circuit.

Effect of Polymer Coating (Poly 2-Methoxyethylacrylate) of the Oxygenator on Hemostatic Markers During Cardiopulmonary Bypass in Children

Heparin and other oxygenator coatings have been used in attempts to reduce hemostatic activation during cardiopulmonary bypass (CPB). This study evaluated whether an oxygenator coated with poly 2-methoxyethylacrylate (PMEA) (X-coating; Terumo Corporation, Tokyo, Japan) would cause less activation of coagulation and fibrinolytic systems during CPB in children than a noncoated oxygenator. Observational study. University-affiliated children's hospital. Twenty-six patients, 3 months to 5 years old, who underwent congenital heart surgery for repair of a ventricular septal defect, atrial septal defect, or both. Patients were divided into 2 age-matched groups based on the type of oxygenator used: a noncoated oxygenator (group NC) versus a PMEA-coated oxygenator (group C). Blood samples for coagulation and fibrinolytic markers were compared before, during, and after CPB. Despite increases in thrombin generation markers (F1.2 and TAT) at certain times during CPB in group C compared to group NC, a comparison over all times during CPB were not statistically different between groups. Overall D-dimer concentrations during CPB were elevated in group C compared to group NC (p = 0.02). Active tPA and active PAI-1 were not different between groups during or after CPB. Group C had higher platelet counts (181,000 +/- 29,000) during CPB than group NC (155,000 +/- 57,000, p = 0.04) but not postoperatively. Twelve hours postoperatively, chest tube outputs were 8.8 +/- 3 mL/kg in group C and 19.1 +/- 12 mL/kg in group NC (p = 0.003). The corresponding outputs 24 hours after surgery were 12.4 +/- 3 mL/kg and 24 +/- 11 mL/kg, respectively (p = 0.005). Except for a somewhat higher platelet count during CPB, there was no indication that PMEA coating resulted in less activation of coagulation and fibrinolytic systems. The lower postoperative chest tube output observed after CPB with PMEA-coated oxygenators needs to be studied further.

In Vivo Comparison Study of FDA-Approved Surface-Modifying Additives and Poly-2-Methoxyethylacrylate Circuit Surfaces Coatings During Cardiopulmonary Bypass

The purpose of this double-blind prospective and randomized study was to examine the effects of surface-modifying additives (SMAs) and poly-2-methoxyethylacrylate (PMEA) circuits on platelet count, platelet function (Sonoclot), postoperative chest tube drainage volume, peri- and postoperative blood product use, extubation time, and intensive care time. Terumo noncoated, Terumo-coated (PMEA), Cobe noncoated, and Cobe coated (SMA) circuits were evaluated to find the most cost-effective way to improve patient outcomes. We aimed to find if an additional charge for a coated CPB circuit would be recovered by reducing other patient costs (blood transfusions, intensive care unit time, and bring back postoperative bleeding). An initial literature review revealed the comparison of PMEA circuits vs. noncoated circuits and SMA circuits vs. noncoated circuits in both adult and porcine models. Both SMA- and PMEA-coated circuits decreased platelet consumption, platelet factor release, and the overall perioperative inflammatory response while on cardiopulmonary bypass (CPB). The question not answered in an initial search was simply, “which coated circuit is best for the patient: SMA or PMEA?” Research comparing the above coated circuits each other was not found. The study was approved by the Institutional Review Board. Thirty patients were scheduled for elective coronary artery bypass grafting and/or valvular repair or replacement surgery. These 30 patients were randomized as 10 patients to Terumo X-Coating (PMEA surface coating) (CT), 10 patients to Cobe Smart-X coating (SMA surface coating; CC), 5 patients to Terumo noncoated tubing (NCT), and 5 patients to Cobe noncoated tubing (NCC). Informed consent was obtained from each patient before surgery. The data showed no statistically significant relationship between platelet counts, platelet function (Sonoclot), postoperative chest tube drainage volume, peri- and postoperative blood products, intensive care unit time, or total hospital length of stay. Analysis revealed statistically significant clinical associations of extubation time and protamine dose with treatment group. This study provided evidence that SMA- and PMEA-coated circuits do not improve platelet consumption or decrease blood product use for patients undergoing CPB. There was statistical significance with a reduction in extubation time and total protamine requirement needed to return activated clotting time (ACT) to baseline post-CPB. Although the use of SMA and/or PMEA circuits during CPB has clinical benefit to the CPB patient, an additional charge for the specialty circuit may not be realized.

A new poly-2-methoxyethylacrylate-coated cardiopulmonary bypass circuit possesses superior platelet preservation and inflammatory suppression efficacy

Background Poly-2-methoxyethylacrylate (PMEA) is a new coating material, and several studies have revealed that PMEA-coated cardiopulmonary bypass (CPB) circuits have good biocompatibility. This study sought to compare this biocompatibility with those of heparin-coated and noncoated circuits. Methods Forty-five patients undergoing coronary artery bypass grafting were randomly assigned to PMEA-coated (group P, n = 15), heparin-coated (group H, n = 15), or noncoated (group N, n = 15) circuit groups. Clinical data and the following markers were analyzed: (1) platelet preservation by number of platelets; (2) complement (C) activation by C3a and C4a levels; (3) inflammatory response by interleukin-6 (IL-6) and interleukin-8 (IL-8) levels. Results Platelet numbers were significantly preserved in group P compared with groups N and H. Postoperative blood loss did not differ among the groups. During CPB, C3a values were significantly lower in group H (536 ± 145 ng/mL) than in group P (1,458 ± 433 ng/mL, p < 0.01) and group N (1,815 ± 845 ng/mL, p < 0.01). The C4a values did not differ 60 minutes after CPB initiation among the groups. The IL-6 and IL-8 levels were significantly lower in group P and groupH than in group N. Conclusions The PMEA coating was superior to heparin coating and noncoating in preserving platelets, and was equivalent to heparin coating in terms of the perioperative clinical course and inhibition of inflammatory cytokines, but slightly inferior in reducing complement activation.

Poly2-methoxyethylacrylate (PMEA) coated oxygenator: an ex vivo study.

PMEA is a hydrophilic polymer coating with a unique design that minimizes the adsorption and denaturation of proteins and blood cells. This study compares thrombus resistance, blood path resistance, thrombocyte profile, and blood trauma of the PMEA coated Capiox membrane oxygenator (Terumo, Japan) vs. an uncoated version. Six calves (mean bodyweight: 75.3 +/- 4.5kg) were placed on cardiopulmonary bypass for 6 hours and randomly assigned to the coated or uncoated oxygenator, with a low heparinisation protocol (ACT > 180s). Macroscopically, red staining was observed in all uncoated oxygenators, and in none of the coated ones. Inlet pressure was significantly higher in the uncoated group (at 1 h: 279 +/- 25 vs. 175 +/- 11mmHg, p < 0.01 and at 6h: 217 +/- 10 vs. 171(8mmHg, p < 0.01). Thrombocyte count values (corrected for hematocrit and normalized by prebypass values) were significantly higher in the coated group (at 1 h: 76 +/- 6 vs. 53 +/- 13%, p < 0.01 and at 6 h: 70 +/- 6 vs. 44 +/- 26%, p < 0.01). Plasma hemoglobin was below 100mg/L in both groups throughout the experiments. When compared with uncoated oxygenator, PMEA coated oxygenator exhibited increased thrombus resistance with lower inlet pressure and lower thrombocyte consumption. In both groups, trauma to red cells was minimal, emphasizing the efficient design of this type of oxygenator.

Efficacy of a new coating material, PMEA, for cardiopulmonary bypass circuits in a porcine model

Background. A new coating material, poly-2-methoxyethyl acrylate (PMEA), was developed to improve the biocompatibility of cardiopulmonary bypass (CPB) circuits.Methods. To investigate the efficacy of the PMEA coating for CPB circuits, we compared PMEA-coated circuits (group P, n = 6) with uncoated circuits (group C, n = 6) and heparin (covalent-bonded heparin, Hepaface)-coated circuits (group H, n = 6) in a porcine CPB model.Results. Platelet counts were significantly preserved in groups P and H compared with those in group C (P versus C, p < 0.05). The plasma levels of thrombin-antithrombin complex and bradykinin were significantly lower at 120 minutes in groups P and H than in group C (thrombin-antithrombin: P versus C, p < 0.05; bradykinin: P versus C, p < 0.05). The amount of fibrinogen adsorbed onto the hollow fibers was markedly less in group P than in groups C and H.Conclusions. The PMEA coating was equal to heparin coating in preventing reactions induced by CPB circuits, and might be superior to heparin coating in suppressing the adsorption of plasma proteins such as fibrinogen. Thus, PMEA coating may be a suitable means for improving the biocompatibility of CPB circuits.

THE EFFICACY OF X-COATED CARDIOPULMONARY BYPASS CIRCUIT SYSTEMS IN PATIENTS WITH OPEN HEART SURGERY

[Background] We have reported the efficacy of a new coating material, poly-2-methoxyethyl acrylate (PMEA) for cardiopulmonary bypass (CPB) circuit in porcine PCPS models. In this study, we evaluated the efficacy of PMEA coating (X coating®) in patients with open heart surgery. [Methods and Materials] Twenty-one patients underwent valve surgeries under X-coated CPB circuits (group X, n=5), non-coated circuits (group C, n=8) or heparin (ionically bound-heparin, Hepaface®)-coated circuits (group H, n=8). We analyzed the complement system, inflammatory system, platelet system and coagulofibrinolytic system in blood samples, after anesthesia induction, 10min after heparin administration, 30min after extracorporeal circulation establishment, 60min after protamine administration. We also examined plasma proteins adsorbed onto the hollow fibers of the oxygenators after CPB in each group. [Results]Platelet system: Platelet counts decreased gradually during CPB in all groups. There were no significant differences between 3 groups. The plasma levels of platelet factor 4 and P-selectin were lower in group X than in group C. Complement system: The elevations in plasma C3a levels were less in group X than in group C. They were equal to in group H. Coagulofibrinolytic system: The plasma levels of TAT complex and D-dimer were lower in group X than in group C. Inflammatory system: The plasma levels of IL-6 and IL-8 were lower in group X than group C. Adsorbed plasma proteins, especially fibrinogen were markedly less in group X than in group C and H. [Conclusion] In this clinical study, the superior biocompatibility of X-coating was confirmed as CPB coating material, and its efficacy seemed to be compatible to heparin coating as for various chemical reactions induced by CPB. In addition, it may exceed the heparin coating as for suppression of the adsorption of plasma proteins such as fibrinogen. X coating may be suitable for the improvement of biocompatibility of CPB in the clinical settings.