scholarly journals Essential Thrombocythemia: A Comparison of Overall and Thrombosis Free Survival in Two Discrete Periods of the First Decade of 2000. a Retrospective Analysis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5469-5469
Author(s):  
Marco Montanaro ◽  
Ambra Di Veroli ◽  
Marianna De Muro ◽  
Cristina Santoro ◽  
Massimo Breccia ◽  
...  

Abstract To evaluate the prognosis of patients with Essential Thrombocythemia (ET) in the first decade of the century we assessed retrospectively the thrombosis free survival (TFS) and the overall survival (OS) of the patients diagnosed from 01/01/2000 to 31/12/2009 and collected in the database of our group. The diagnosis of ET was performed with PVSG, WHO 2001 or WHO 2008 criteria, according to the period of the first observation. The whole population of 757 patients was then divided in two groups: the first (group I) with the diagnosis performed between 01/01/2000 to 31/12/2005 (334 patients) with a median follow-up of 111,9 months, the second (group II) diagnosed between 01/01/2006 to 31/12/2009 (385 patients) with a median follow-up of 58,2 months. The main clinical features of the two groups of patients are reported in the Table 1. No difference was observed between the two groups as to age, gender, platelet and WBC count, Hb level, Cardio-Vascular Risk Factors (CVRF), spleen enlargement and occurrence of previous thrombotic events. The frequency of the JAK-2 V617F mutation resulted significantly different (49.1% vs 68.4%) but in the group I the search of the mutation was never performed at the diagnosis. The TFS and OS were calculated from the date of diagnosis to the date of any appropriate event or to the date of last follow-up with Kaplan-Meier product limit method; the comparison of proportions and median values was computed with the Chi-squared and the Mann-Withney tests, as indicated. No significant difference emerged neither for TFS (p= 0,09, HR 1,42, 95% C.I. 0.89-2.30) nor for OS (p= 0,15, HR 1,34, 95% C.I. 0,87-2,06). We also considered the type of treatment used in the two groups to assess the potential link between the therapy and TFS or OS. No difference emerged between the two groups as to anti-aggregating treatment (mainly ASA), equally utilized in both groups [287/369, 77,8%, and 330/383, 78,3%, respectively (p = 0,95)]. As for the cyto-reductive therapy, Hydroxyurea was used in 74.8% vs 67.9% (p= 0.60) and alkylating agents in 1.9% vs 2.1% (p= 0.85), whereas Anagrelide was used in 10,6% vs 3,9% (p= 0,001) and Interferon in 9,5% vs 5,2% (p= 0,037), respectively. This more frequent use of Anagrelide and Interferon in the first group (2000-2005) did not modify TFS and OS of the patients. In conclusion, no improvement was observed in the prognosis of ET patients in the recent years: thus, new efforts to identify patients at risk and the introduction of new drugs as JAK-2 inhibitors are warranted to improve the prognosis of these patients. Table Table. Disclosures Breccia: Bristol Myers Squibb: Honoraria; Pfizer: Honoraria; Novartis: Consultancy, Honoraria; Celgene: Honoraria; Ariad: Honoraria. Cimino:Celgene: Honoraria; Bristol-Mayer: Honoraria. Lo Coco:Pfizer: Consultancy; Baxalta: Consultancy; Novartis: Consultancy; Lundbeck: Honoraria, Speakers Bureau; Teva: Consultancy, Honoraria, Speakers Bureau. Latagliata:Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Janssen: Consultancy, Honoraria; Shire: Honoraria.

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2815-2815
Author(s):  
Marco Montanaro ◽  
Roberto Latagliata ◽  
Michele Cedrone ◽  
Ambra Di Veroli ◽  
Cristina Santoro ◽  
...  

Abstract The protective effect of higher platelet count at diagnosis of Essential Thrombocythemia (ET) was reported in some papers (Carobbio A. 2011, Palandri F. 2012, Montanaro M., 2014). As at our knowledge, there is no study specifically addressing this point; in this retrospective analysis we have examined 1201 ET patients (pts) followed in 11 Hematological centers of our region from 1/1978 to 12/2010. The diagnosis of ET was made with PVSG, WHO 2001 and WHO 2008 criteria, respectively, according to the period of 1st observation. The main features of our cohort were as follows: median age 62,9 yrs (19-96), male/female 435/766 (36.2%/63.8%), median WBC count 8,8 x 106/L (1.2-57.7), median Hb level 14.0 g/dl (6.0-20.5), median platelet count 813 x 106/L (457-3582), JAK-2V617F mutation in 498/834 performed pts (59,7 %) with a median allele burden of 19.6% (0.2-99.9%), spleen enlargement in 226 pts (18.7%), previous thrombosis in 17.9% of pts (arterial 14.1%, venous 3.8%). The median follow-up of the entire cohort was 7.75 yrs. Thrombosis-free survival curves were plotted according to Kaplan-Meier method and independent risk factors were identified with the Cox proportional-hazards method. At the multivariate analysis, negative prognostic factors for TFS resulted: previous thrombotic events (p= 0.012), age ≥60 yrs (p= 0.008) and spleen enlargement (p= 0.039): on the contrary, platelet count ≥ 944.109/L resulted a protective factor for TFS [p= 0.031 with an HR 0,57 (C.I. 95% 0,35-0,95)]. Receiver operating characteristic (ROC) analyses based on thrombotic events during follow-up were used to identify the baseline platelet count of 944 x 109/L as the best threshold for predicting thrombotic events. Thrombotic events according to this cutoff were 40/384 (10.3%) in pts with platelet count ≥ 944 x 109/L and 109/817 (13.3%) in pts with platelet count < 944 x 109/L. The sites of thrombosis are reported in the table. A comparison of the main features in these two populations showed that pts with PLT count < 944 x 109/L were older (median age 60.4 yrs vs 57.1 yrs, p= 0.016), had a lower median WBC count (8.8 x 109/L vs 10.6 x 109/L, p< 0.0001), an higher median Hb level (14.1 g/dL vs 13.6 g/dL, p< 0.0001) and an higher rate of JAK-2V617F mutation (67.2% vs 41.6%, p< 0.0001); no differences were observed between the two groups as to thrombotic events before diagnosis, spleen enlargement and cardiovascular risk factor (p=NS). As to the treatment, both groups resulted equally treated with anti-aggregant agents (84,6% vs 87,4%, p= 0,76) while in pts with platelet count <944 x 109/L the oral anticoagulants (7.1% vs. 3.1%, p= 0.01) were more often used. Pts with higher platelet count were more frequently treated with cyto-reductive drugs (90,4 % vs 76,4 %, p< 0.0001). No significant difference resulted for Hydroxyurea (70,8 % vs 64,3%, p= 0,34) and Interferon ( 11,7% vs 6,9%, p= 0,07); on the contrary, more pts with higher platelet count were treated with anagrelide (10.7% vs 5.0%, p= 0.001) and alkylating agents (8.9% vs 5.1%, p= 0.03). In conclusion, our retrospective analysis confirmed the protective role for thrombosis of an higher platelet count at diagnosis. Pts with platelet count ≥ 944 x 109/L were more frequently treated with cyto-reductive drugs and this could possibly explain the better TFS, even if the platelet count closer to the occurrence of a thrombotic event resulted near the normal values in both groups. On the other hand, the higher rate of JAK-2V617F mutation in the group of pts with a baseline lower platelet count could be responsible of this counterintuitive finding: it is worth of note, however, that in our series the JAK-2V617F mutation did not result a significant factor for TFS. Table 1.TYPESITEPLTs ≥ 944PLTs <944ARTERIALCardiac10 (2.6%)20 (2.5%)CNS*9 (2.3%)39 (4.8%)Peripheral2 (0.5%)6 (0.7%)Splanchnic1 (0.3%)1 (0.1%)Total22/384 (5.7%)66/817 (8.1%)VENOUSPeripheral17 (4.4%)32 (3.9%)Atypical03 (0.4%)Splanchnic1 (0.2%)7 (0.9%)Total18/384(4.6%)42/817(5.2%)*Central Nervous System; ° Non tested Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5248-5248
Author(s):  
Luigi Gugliotta ◽  
Alessia Tieghi ◽  
Anna Candoni ◽  
Monia Lunghi ◽  
Gianluca Gaidano ◽  
...  

Abstract Background: the Registro Italiano Trombocitemia, that is a GIMEMA project, has been activated to registry Italian Essential Thrombocythemia (ET) patients, to improve the diagnosis appropriateness (WHO criteria), to verify the prognostic value of the clinical and biological parameters, to evaluate the compliance to the therapeutical Italian guidelines (1), and to create a network for activation of new studies. Objective: this analysis is mainly devoted to describe the ET patients registered in the RIT and to evaluate the therapeutic approach adopted in the 102 participating hematological centers. Material and methods: two thousand and fifteen ET patients have been registered after the written informed consent was obtained, and data validation by various expert panels is in progress. This preliminary report considers 1785 patients, diagnosed mainly (1078, 60.4%) since the publication in the year 2004 of the ET therapy Italian guidelines (1). Results: the patients, 678 (38%) males and 1107 (62%) females, showed at diagnosis: age 60.3 ± 16.8 years with higher values in males than in females (61.7 ± 15.3 vs. 59.4 ± 17.7, p&lt;0.05), being the patients below 40 years 14% and those over 70 years 33% of cases; PLT count (109/L) 846 ± 309 with lower values in males than in females (813 ± 261 vs. 866 ± 334, p&lt;0.002), and with values 1001–1500 and over 1500 in 16% and 4% of cases, respectively; WBC count (109/L) 9.1 ± 2.9, without difference by sex, and with values 12–15 in 10% and over 15 in 3% of cases; Hgb (g/dL) 14.2 ± 1.6 with higher values in males than in females (14.8 ± 1.5 vs. 13.8 ± 1.5, p&lt;0.001), and with values over 16.5 in 8.5% of males and 2.7% of females, respectively; splenomegaly in 488 (27%), echo-documented in 324 cases (18%); history of hemorrhage and thrombosis in 90 (5%) and 325 (19%) of cases, respectively; disease-related symptoms in 41% and general thrombotic risk factors in 93% of cases, respectively. The WHO 2001 diagnostic criteria were reported for 33% of cases observed before the year 2004 and for 53 % of cases observed since the year 2004. Detailed data at diagnosis were reported as follows: bone marrow biopsy in 1087 cases (61%) with a frequency of 51% and 68% before and since the year 2004, respectively; bcr-abl study in 1045 cases (59%); cytogenetics in 828 cases (46%) with karyotype abnormalities in 27 patients (3%). The JAK2 V617F mutation, searched in 574 cases (32%), was observed in 320 of them (56%). The patient follow-up was 4.5 ± 4.5 years with a total of 5245 pt-yrs. During the follow-up the hemorrhagic events were 5.7% (1.3/100 pt-yrs), being the major events 1.9% (0.4/100 pt-yrs); the thrombotic complications were 14.9 % (3.3/100 pt-yrs), resulting the major arterial 9.4% (2.1/100 pt-yrs), the major venous 3.5% (0.8/100 pt-yrs) and the minor thrombosis 2% (0.4/100 pt-yrs). An antiplatelet treatment, almost always with low dose aspirin, was performed in 75% of the patients, without significant difference in the cases diagnosed before and since the 2004. A cytoreductive treatment was done with use of Hydroxyurea (HU, 64%), Interferon alpha (IFN, 16%), Anagrelide (ANA, 15%), Busulfan (BUS, 4%), and Pipobroman (PIPO, 2 %). In the ET patients diagnosed since the year 2004 respect those diagnosed before, it was observed a decrease in the use of all the cytoreductive drugs, particularly BUS (−62%), IFN ((−62%), and ANA ((−68%). The use of the cytoreductive drugs was related to the patient mean age (years): BUS (76), PIPO (72), HU (67), ANA (53), IFN (48). In the patients diagnosed since the 2004 as compared with those before 2004, the mean age of the treated patients increased for BUS (from 69 to 81 yrs, p&lt;0.001) and for HU (from 64 to 69 yrs, p&lt;0.001) while it decreased for IFN (from 49 to 46 yrs, p&lt;0.05). Conclusion: in the analyzed patients of the ET Italian registry the diagnosis appropriateness resulted improved in the cases observed since the year 2004 respect those observed before, with an increase of bone marrow biopsies from 51% to 68% of patients. Moreover, in accord with the ET therapy Italian guidelines, the use of the cytoreductive drugs was less frequent in the patients diagnosed since the year 2004 than before (particularly for BUS, IFN, and ANA) and the more safe molecules IFN and ANA were preferentially deserved to the younger patients.


2020 ◽  
Vol 72 (1) ◽  
Author(s):  
Mohammad Abdallah Eltahlawi ◽  
Abdel-Aziz Fouad Abdel-Aziz ◽  
Abdel-Salam Sherif ◽  
Khalid Abdel-Azeem Shokry ◽  
Islam Elsayed Shehata

Abstract Background We hypothesized that 1st generation everolimus-eluting bioresorbable vascular scaffold (BVS) stent associated with less complication and less restenosis rate than everolimus-eluting stent (EES) in chronic total occlusion (CTO) recanalization guided by intracoronary imaging. Therefore, we aimed to assess the safety and performance of BVS stent in CTO revascularization in comparison to EES guided by intracoronary imaging. Our prospective comparative cross-sectional study was conducted on 60 CTO patients divided into two groups according to type of stent revascularization: group I (EES group): 40 (66.7%) patients and group II (BVS group): 20 (33.3%) patients. All patients were subjected to history taking, electrocardiogram (ECG), echocardiography, laboratory investigation, stress thallium study to assess viability before revascularization. Revascularization of viable CTO lesion guided by intracoronary imaging using optical coherence tomography (OCT). Then, long-term follow-up over 1 year clinically and by multi-slice CT coronary angiography (MSCT). Our clinical and angiographic endpoints were to detect any clinical or angiographic complications during the follow-up period. Results At 6 months angiographic follow-up, BVS group had not inferior angiographic parameters but without statistically significant difference (p = 0.566). At 12 months follow-up, there was no difference at end points between the two groups (p = 0.476). No differences were found at angiographic or clinical follow-up between BVS and EES. Conclusion This study shows that 1st generation everolimus-eluting BVS is non-inferior to EES for CTO revascularization. Further studies are needed to clearly state which new smaller footprint BVS, faster reabsorption, magnesium-based less thrombogenicity, and advanced mechanical properties is under development. We cannot dismiss the efficacy and safety of new BVS technology. Trial registration ZU-IRB#2498/3-12-2016 Registered 3 December 2016, email: [email protected]


Blood ◽  
2012 ◽  
Vol 120 (7) ◽  
pp. 1409-1411 ◽  
Author(s):  
Peter J. Campbell ◽  
Cathy MacLean ◽  
Philip A. Beer ◽  
Georgina Buck ◽  
Keith Wheatley ◽  
...  

Abstract Essential thrombocythemia, a myeloproliferative neoplasm, is associated with increased platelet count and risk of thrombosis or hemorrhage. Cytoreductive therapy aims to normalize platelet counts despite there being only a minimal association between platelet count and complication rates. Evidence is increasing for a correlation between WBC count and thrombosis, but prospective data are lacking. In the present study, we investigated the relationship between vascular complications and 21 887 longitudinal blood counts in a prospective, multicenter cohort of 776 essential thrombocythemia patients. After correction for confounding variables, no association was seen between blood counts at diagnosis and future complications. However, platelet count outside of the normal range during follow-up was associated with an immediate risk of major hemorrhage (P = .0005) but not thrombosis (P = .7). Elevated WBC count during follow-up was correlated with thrombosis (P = .05) and major hemorrhage (P = .01). These data imply that the aim of cytoreduction in essential thrombocythemia should be to keep the platelet count, and arguably the WBC count, within the normal range. This study is registered at the International Standard Randomized Controlled Trials Number Registry (www.isrctn.org) as number 72251782.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chunlong Huang ◽  
Xiaoyuan Gu ◽  
Xianshang Zeng ◽  
Baomin Chen ◽  
Weiguang Yu ◽  
...  

Abstract Background An upgraded understanding of factors (sex/estrogen) associated with survival benefit in advanced colorectal carcinoma (CRC) could improve personalised management and provide innovative insights into anti-tumour mechanisms. The aim of this study was to assess the efficacy and safety of cetuximab (CET) versus bevacizumab (BEV) following prior 12 cycles of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus BEV in postmenopausal women with advanced KRAS and BRAF wild-type (wt) CRC. Methods Prospectively maintained databases were reviewed from 2013 to 2017 to assess postmenopausal women with advanced KRAS and BRAF wt CRC who received up to 12 cycles of FOLFOXIRI plus BEV inductive treatment, followed by CET or BEV maintenance treatment. The primary endpoints were overall survival (OS), progression-free survival (PFS), response rate. The secondary endpoint was the rate of adverse events (AEs). Results At a median follow-up of 27.0 months (IQR 25.1–29.2), significant difference was detected in median OS (17.7 months [95% confidence interval [CI], 16.2–18.6] for CET vs. 11.7 months [95% CI, 10.4–12.8] for BEV; hazard ratio [HR], 0.63; 95% CI, 0.44–0.89; p=0.007); Median PFS was 10.7 months (95% CI, 9.8–11.3) for CET vs. 8.4 months (95% CI, 7.2–9.6) for BEV (HR, 0.67; 95% CI 0.47–0.94; p=0.02). Dose reduction due to intolerable AEs occurred in 29 cases (24 [24.0%] for CET vs. 5 [4.8%] for BEV; p< 0.001). Conclusions CET tends to be superior survival benefit when compared with BEV, with tolerated AEs.


2021 ◽  
Author(s):  
Leena Metso ◽  
Ville Bister ◽  
Arsi Harilainen ◽  
Jerker Sandelin

Abstract Background: This is a five years follow-up report of some of the new devices for graft fixation. A two years follow-up data was published previously. As there were no statistically or clinically relevant differences in the results two years postoperatively, we hypothesize that after five years of follow-up there is no difference in the outcome after either cross-pin or absorbable interference screw fixation in ACL (anterior cruciate ligament) reconstruction with hamstring tendon autografts.Methods: 120 patients were randomized into four different groups (30 each) for ACL reconstruction with hamstring tendons: group I femoral Rigidfix cross-pin and Intrafix tibial extension sheath with a tapered expansion screw; group II Rigidfix femoral and BioScrew interference screw tibial fixation; group III BioScrew femoral and Intrafix tibial fixation; group IV BioScrew fixation into both tunnels. The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements. Results: In this 5 years follow-up there were 102/120 (85%) patients available, but only 77 (64,2%) attended the clinical examinations. No significant difference between the groups in the clinical results was detected. There was a significant difference in additional procedures between the 2 and 5 years follow-up, group I had six additional procedures between the 2 and 5 years follow-up (P=.041). Conclusion: There was a statistically significant difference in the additional procedures, most in group I (six). None of these procedures found problems with the ACL graft. Other statistically or clinically significant differences in the 5 years follow-up results were not found. Study design: Randomized controlled clinical trial; Level of evidence, 1.Trial registration: ISRCTN registry with study ID ISRCTN34011837. Retrospectively registered 17.4.2020.


2004 ◽  
Vol 51 (1) ◽  
pp. 103-107
Author(s):  
Nenad Arsovic ◽  
Radomir Radulovic ◽  
Snezana Jesic ◽  
S. Krejovic-Trivic ◽  
P. Stankovic ◽  
...  

Past experience with open and closed techniques of tympanoplasty in surgery of cholesteatoma has shown that recurring illness is one of the major causes of surgical failure. The literature has reported varying trend of surgical treatment of cholesteatoma. The objective of the study was to analyze the significance of surgical technique in relation to the incidence and most frequent localization of recurrent cholesteatoma. Our study analyzed 120 patients operated on for cholesteatoma. The patients were divided into two groups, group I (45) with recurring disease and group II (75) without any recurring condition, which were followed up three years. Statistical analysis was carried out by modified t-test. The largest number of patients was re-operated in the first two years from the initial surgery (50%), In the majority of patients (50%), recurrent cholesteatoma was most commonly localized (stage I) in attic (20%) and much rarely in mesotympanum (11,9%). Stage III recurrent cholesteatoma was verified in 35% of patients, most frequently diffuse form (13,4%). The involvement of attic by all three stages of disease accounted for over 60%. The analysis of the used techniques of surgical treatment in both groups revealed significant difference. Open techniques of tympanoplasty were used in 60% of patients with no recurrence. Closed techniques were used more frequently in patients with recurring disease, i.e. in over 90% of cases. Recurrent cholesteatoma develops, in the majority of cases, during the first two years after the surgical intervention. Attic is the most common localization of cholesteatoma. More frequent utilization of open technique of tympanoplasty for surgery of cholesteatoma significantly reduces the incidence of recurring condition. The indications for CWD technique are the initial spread of cholesteatoma, possibility of complete removal of cholesteatoma and postoperative follow-up of patients.


2021 ◽  
Vol 9 (D) ◽  
pp. 103-107
Author(s):  
Hisham Samir ElGabry

PURPOSE: This study aimed to compare patients’ satisfaction with mandibular overdentures retained by three-splinted implants versus conventional complete denture wearers during a 7-year follow-up study period. MATERIALS AND METHODS: Thirty edentulous male patients (mean age: 60 years) were carefully selected and divided into two equal groups. All patients received a new set of complete dentures. Group I patients received three implants in the anterior mandible and were connected after 3 months with bars, clips, and loaded. Group II patients received conventional complete dentures. Patients’ satisfaction was recorded for both groups at 3 weeks (baseline) and after 1, 3, 5, and 7 years. Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction. RESULTS: Satisfaction scores of Group I patients were found to be statistically significantly higher than that of Group II patients (p < 0.05) at 3, 5, and 7 years follow-up, meanwhile, no statistically significant difference was found at baseline or after 12 months. CONCLUSION: The long-term results suggest that three-implant-retained mandibular overdenture with a clip-bar attachment appears to be a successful rehabilitation strategy which is superior to conventional dentures for patients with advanced ridge resorption.


2012 ◽  
Vol 147 (5) ◽  
pp. 937-942 ◽  
Author(s):  
Sameh M. Ragab ◽  
Hossam S. Elsherif ◽  
Emad M. Shehata ◽  
Ahmed Younes ◽  
Ahmed M. Gamea

Objectives (1) To conduct an adequately powered randomized controlled trial investigating the safety and efficacy of mitomycin C–enhanced revision endoscopic dacryocystorhinostomy (DCR) and (2) to analyze causes of failure after primary endoscopic DCR. Study Design A randomized controlled study. Setting General hospital. Subjects and Methods Seventy-six revision endoscopic DCRs were randomized into 2 groups: endoscopic DCR with mitomycin (group I), where 0.5 mg/mL mitomycin C was applied for 10 minutes, and endoscopic DCR without mitomycin (group II). Follow-up settings were done to document the patient’s subjective improvement, to judge ostium patency on irrigation, and to record any complications. Results Causes of failure in the original 92 patients included canalicular obstruction (14%), small misplaced bony window (43%), very small nasolacrimal stoma due to development of synechia (23%), and complete closure of nasolacrimal stoma with tough fibrous tissue (63%). There was no significant difference between the 2 groups in subjective and objective success rates and adverse events. Group I demonstrated a significantly longer operative time and a significantly lower number of debridement sessions (mean of 1.2 vs 1.9). Conclusions Recurrent nasolacrimal duct obstruction after primary endoscopic DCR is mainly due to reclosure of the nasolacrimal stoma with synechia and fashioning of the small misplaced bony window. Mitomycin C does not increase the success rate of revision endoscopic DCR. It is a safe procedure and may be of value only in patients inaccessible to strict follow-up because it induces a better healing profile in terms of mucosal recovery, wound healing, and less need for debridement sessions.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Nirvana Sadaghianloo ◽  
CONTENTI Julie ◽  
Vido Sandor ◽  
Carboni Joseph ◽  
Bonnet Sophie ◽  
...  

Abstract Background and Aims Despite recommendations for a close follow-up of arteriovenous fistulas (AVF), thombosis rate reaches 10% each year. Conventional follow-up modalities remain a burden for hemodialysis patients. We tested the hypothesis that osteopontin (OPN), a pro-inflammatory molecule related to intimal hyperplasia, could be a biological marker of stenosis, and could thereby allow a screening of patients at risk for AVF dysfunction. Method Our prospective study (NCT03270358) compared the rate of plasmatic OPN between patients with a good-functioning AVF (control group, N= 39) and patients who required surgical or endovascular revision of their AVF because of a stenosis (stenosis group, N= 37). Blood samples were taken in the AVF, at the time of AVF cannulation in control patients, and at the time of AVF revision in stenosis patients. For each patient, blood from the contralateral arm was also analyzed as a between-subject control (paired t test). Cardiovascular risk factors, ongoing medications, and OPN rates (ELISA technique) were compared among the groups (uni- and multivariate analysis). The ROC curve determined sensitivity and specificity of the marker for the detection of stenosis. Results Patients' characteristics were similar between the 2 groups (mean age, 70 years; men, 63%; AVF duration; 39 months), apart from diabetes (control group, 33%; stenosis group, 57%; p=0.04). The rate of OPN was similar between the AVF arm and the contralateral arm (p=0.11), but significantly increased in the stenosis group compared to the control group (655 vs. 452 ng/mL, respectively, p=0.02). There was no statistically significant difference in OPN rate for diabetics and non diabetics (two-way ANOVA, p= 0.50). Sensitivity was 89% for a threshold &gt;293ng/mL and specificity was 80% for a threshold &gt;567ng/mL (AUC: 0.70; 95%CI: 0.57-0.81; p=0.004). Patients with an OPN rate ≥293ng/mL and those with an OPN rate ≥567ng/mL had respectively 8.87 and 15.62 higher odds to have a stenosis than patients with an OPN rate &lt;293ng/mL (binomial regression, p&lt;0.01). Conclusion Plasmatic OPN rate in hemodialysis patients can be measured simply, in a blood sample taken at the time of AVF cannulation, and is strongly correlated to the presence of a symptomatic AVF stenosis. This biomarker could help the physician choose which patient need a comprehensive examination of his/her AVF with duplex ultrasound or fistulogram.


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