Thrombotic Events in Lupus Anticoagulant Positive Patients Prospectively Correlate with Clinical Risk Factors - the Vienna Lupus Anticoagulant and Thrombosis Study (LATS)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 652-652
Author(s):  
Florian Posch ◽  
Johanna Gebhart ◽  
Jacob H. Rand ◽  
Bas de Laat ◽  
Silvia Koder ◽  
...  
Keyword(s):  
Risk Factors ◽  
Lupus Anticoagulant ◽  
Risk Group ◽  
Multivariable Analysis ◽  
Low Risk ◽  
Active Smoking ◽  
Thrombotic Risk ◽  
Glycoprotein I ◽  
Prolonged Aptt

Abstract INTRODUCTION: Patients with the lupus anticoagulant (LA) are at an increased risk of thrombotic events (TE), which in turn increase the risk of death (Gebhart J et al. Blood. 2015. 125:3477). Understanding the determinants of thrombotic risk in LA patients may pave the way towards targeted thromboprophylaxis. To date, several retrospective studies have investigated the association between anamnestic thrombosis and certain factors, such as antibodies against cardiolipin and beta2-glycoprotein I. However, robust prospective evidence is still limited. We aimed to investigate clinical and laboratory risk factors for development of TE in patients with a persistently positive LA. PATIENTS & METHODS: In this prospective, observational cohort study with a baseline biobank we followed 150 patients (median age: 41.3 years, interquartile range (IQR): 32.3-60.2, female gender: n=122 (81.3%)), who tested repeatedly positive for the LA until the development of TE, death, or censoring. The primary endpoint was the time-to-TE during the observation period, defined as a composite of arterial or venous, independently-adjudicated thrombotic complications. Ninety-eight (65.3%) of the 150 patients had a history of at least one TE event (arterial TE: n=21, venous TE: n=84, both: n=7), and 70 (46.7%) were on oral anticoagulation at baseline. Sixty-five (43.3%) patients also had IgM and/or IgG isotype antibodies against cardiolipin and beta2-glycoprotein I ("Triple positivity"). For investigation of the LA, lupus-sensitive aPTT reagents were used (aPTT-LA, Diagnostica Stago, Asnieres, France). Prospective associations were analyzed using competing risk analysis treating death-from-any-cause as the competing event. Evaluated risk factors included (1) the lupus-sensitive activated partial thromboplastin time (aPTT-LA), (2) antibodies against cardiolipin, beta2-glycoprotein I, domain 1 of beta2-glycoprotein I, prothrombin, and "triple positivity", (3) general cardiovascular risk factors (diabetes, hypertension, smoking, and hypertriglyceridemia, body mass index), and (4) AnnexinA5 resistance (A5R). RESULTS: During a median follow-up period of 8.7 years (range: 12 days - 12.4 years), 30 TE events occurred (arterial TE: n=14, venous TE: n=16), and 20 patients died. The cumulative incidence of TE at 1, 5, and 10 years of follow-up were 4.0% (95% Confidence Interval (CI): 1.7-8.1), 12.8% (95% CI: 7.9-18.9), and 24.4% (95% CI: 16.8-32.8), respectively. In univariable analysis, a prolonged aPTT-LA (Subhazard ratio (SHR) for aPTT≥118 seconds (i.e. 75th percentile of the aPTT-LA distribution)=2.59, 95%CI: 1.27-5.31, p=0.009), diabetes (SHR=4.36, 95%CI: 1.44-13.19, p=0.009), active smoking (SHR=2.35, 95%CI: 1.16-4.77, p=0.018), and elevated triglycerides (SHR per 50mg/dL increase=1.14, 95%CI: 1.09-1.18, p<0.001) were associated with a higher risk of TE events. In multivariable analysis, the only independent predictors of a higher thrombotic risk were a prolonged aPTT-LA (adjusted SHR=2.33, 95%CI: 1.06-5.13, p=0.035), diabetes (adjusted SHR=3.79, 95%CI: 1.12-12.89, p=0.033), and active smoking (adjusted SHR=2.62, 95%CI: 1.24-5.52, p=0.012). These results prevailed after adjusting for anticoagulation at baseline. Using these three parameters allowed identification of clinical subgroups with a very high and a low risk of TE events (cumulative risk of TE after 5 years 43.3% in the high risk group and 5.6% in the low risk group, respectively, Figure 1). The other risk factors did neither in univariable nor in multivariable analysis emerge as predictors of thrombotic risk in this large cohort. CONCLUSION: Diabetes and smoking, which are established risk factors for vascular events in the general population, turned out to be relevant also in patients with the LA. Moreover, a very long lupus sensitive aPTT was as well predictive for occurrence of TE in these patients. This effect was independent of anticoagulation. Interestingly, disease defining antibodies, such as those against cardiolipin or beta2-glycoprotein I (including those against domain I) were not associated with future occurrence of TE in this LA positive patient population. These data suggest that above standard anticoagulation, interventions to control and improve metabolic status and smoking habits might influence the rates of future TE in patients with known persistent LA. Disclosures No relevant conflicts of interest to declare.

Prevalence, outcome and management of patients with SLE and secondary antiphospholipid antibody syndrome after aPL seroconversion

Rheumatology ◽  
2020 ◽  
Author(s):  
Margherita Zen ◽  
Marta Loredo Martinez ◽  
Francesco Benvenuti ◽  
Mariele Gatto ◽  
Francesca Saccon ◽  
...  
Keyword(s):  
Risk Factors ◽  
Oral Anticoagulation ◽  
Odds Ratio ◽  
Lupus Anticoagulant ◽  
Thrombotic Event ◽  
Modifiable Risk Factors ◽  
Antiphospholipid Antibody ◽  
Antiphospholipid Antibody Syndrome ◽  
Thrombotic Risk

Abstract Objective The withdrawal of oral anticoagulation (OAC) in patients with SLE and secondary aPL syndrome (SAPS) who become seronegative has not been clearly investigated to date. Our aim was to evaluate the prevalence of aPL seroconversion and the prognosis of SLE patients with SAPS who withdrew OAC after aPL negativization. Methods We retrospectively analysed data of all SLE patients (ACR criteria) with SAPS (Sydney criteria) prospectively followed-up in our clinic. aPL seroconversion was defined as negativization of lupus anticoagulant, aCL, and anti-β2glycoprotein-1 antibodies on two or more consecutive measurements, at least 12 weeks apart. OAC discontinuation was defined as the definitive withdrawal of all anticoagulants. Results Fifty-five out of 513 (10.7%) SLE patients had vascular SAPS. Sixteen patients (29.1%) became aPL seronegative during follow-up. Immunosuppressive therapy predicted aPL negativization (odds ratio 5.211, 95%CI 1.341, 20.243), whereas APS diagnosis prior to that of SLE (odds ratio 0.078, 95%CI 0.008, 0.799) and triple-positive profile (odds ratio 0.264, 95%CI 0.115, 0.609) were negative predictors of aPL negativization. OAC was discontinued in 13/55 patients (23.6%), after a median follow-up of 45 months (range 1–276) from aPL seroconversion. SLE-related modifiable risk factors for thrombosis were observed in 10/13 patients (77%) at the time of the thrombotic event. No thrombotic recurrences were observed during a mean follow-up time of 44 (19) months from OAC discontinuation. Conclusions Our results suggest that OAC can be safely discontinued in SLE patients who became persistently seronegative for aPL, at least when aPL-related thrombotic events occurred in presence of other thrombotic risk factors.

A Risk Score Integrating BAALC, ERG and WT1 Expression Can Be Used To Improve Risk Stratification In Acute Promyelocytic Leukemia

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1323-1323
Author(s):  
Anna Hecht ◽  
Florian Nolte ◽  
Daniel Nowak ◽  
Verena Nowak ◽  
Benjamin Hanfstein ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Risk Stratification ◽  
Risk Score ◽  
Risk Group ◽  
Risk Groups ◽  
Low Risk ◽  
Expression Levels ◽  
Improve Risk Stratification

Abstract Introduction With current therapy regimens over 75% of patients with de novo acute promyelocytic leukemia (APL) can be cured. Approaches to further improve patient outcome by stratifying patients at the time of initial diagnosis according to their individual risk and to adjust therapy accordingly have been based on clinical features only. Molecular markers have not been established for risk stratification as yet. Recently, we have shown that high expression levels of the genes brain and acute leukemia, cytoplasmic (BAALC) and ets related gene (ERG) are associated with inferior outcome in APL patients. In addition, data indicate that aberrant expression of the gene Wilms’ tumor 1 (WT1) is a negative prognostic factor with regard to overall survival (OS) after complete remission (CR) and relapse free survival (RFS) in APL. In this study we evaluated the prognostic relevance of a combined score integrating the expression levels of the above mentioned genes to further improve risk stratification in APL patients. Methods Expression levels of BAALC, ERG and WT1 of 62 patients with newly diagnosed APL were retrospectively analyzed in bone marrow mononuclear cells using multiplex reverse transcriptase quantitative real-time PCR (qRT-PCR). Median age of patients was 47 years (range: 19 to 82y). All patients gave informed consent. Patients were diagnosed and treated in the German AML Cooperative Group (AMLCG) study with a treatment of simultaneous ATRA and double induction chemotherapy including high-dose ara-C, consolidation and maintenance chemotherapy. The following gene expression levels were identified as negative risk factors in preceding studies: BAALC expression ≥25th percentile (BAALChigh), ERG expression >75th percentile (ERGhigh) and WT1 expression ≤25th percentile or ≥75th percentile (WT1low/high). A risk score was developed as follows: for the presence of one of the mentioned risk factors one scoring point was assigned to a respective patient, i.e. a maximum of 3 points (one point for BAALChigh, ERGhigh and WT1low/high, respectively) and a minimum of 0 points (i.e. presenting with none of the aforementioned risk factors) could be allocated to one patient. Accordingly, patients were divided into four risk groups: 7 patients scored 0 points (= low risk), 27 patients scored 1 point (= intermediate 1 risk), 19 patients scored 2 points (= intermediate 2 risk) and 9 patients scored 3 points (= high risk). Subsequently, OS, RFS and relapse free interval (RFI) were calculated using the Kaplan-Meier method and a log-rank test was used to compare differences between the four risk groups (p<0.05). Results The integrative risk score divided patients into four groups with significantly different outcome. The low risk group showed a RFS of 100% at 10 years of follow-up compared to the intermediate 1 risk group with 81%, the intermediate 2 risk group with 58% and the high risk group with a RFS of 42% only (median survival: 4.6y) (p=0.02). In accordance, the RFI differed significantly between the four groups: low risk 100%, intermediate 1 risk 100%, intermediate 2 risk 89% and high risk 71% (p=0.049). There was no statistically significant difference between the 4 groups with regard to OS in the entire patient cohort. However, there was a clear trend towards a difference in OS in patients who achieved a CR after induction therapy: low risk 100%, intermediate 1 risk 81%, intermediate 2 risk 68% and high risk 53% survival at 10 years of follow-up (p=0.09). Conclusion Integration of expression levels of the genes BAALC, ERG and WT1 into a scoring system identifies 4 risk groups with significantly different outcome with regard to RFS and RFI. It might be a promising approach to guide therapeutic decisions in patients with APL. However, multivariate analyses and validation of these data in an independent patient cohort is warranted. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Sex differences in coronary artery calcium progression: The Korea Initiatives on Coronary Artery Calcification (KOICA) registry

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0248884
Author(s):  
Wonjae Lee ◽  
Yeonyee E. Yoon ◽  
Sang-Young Cho ◽  
In-Chang Hwang ◽  
Sun-Hwa Kim ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Coronary Artery Calcium ◽  
Risk Group ◽  
Multivariable Analysis ◽  
Low Risk ◽  
Progression Rate ◽  
Atherosclerotic Cardiovascular Disease ◽  
Ascvd Risk ◽  
Male Sex

Even with increasing awareness of sex-related differences in atherosclerotic cardiovascular disease (ASCVD), it remains unclear whether the progression of coronary atherosclerosis differs between women and men. We sought to compare coronary artery calcium (CAC) progression between women and men. From a retrospective, multicentre registry of consecutive asymptomatic individuals who underwent CAC scoring, we identified 9,675 men and 1,709 women with follow-up CAC scoring. At baseline, men were more likely to have a CAC score >0 than were women (47.8% vs. 28.6%). The probability of CAC progression at 5 years, defined as [√CAC score (follow-up)—√CAC score (baseline)] ≥2.5, was 47.4% in men and 29.7% in women (p<0.001). When we stratified subjects according to the 10-year ASCVD risk (<5%, ≥5% and <7.5%, and ≥7.5%), a sex difference was observed in the low risk group (CAC progression at 5 years, 37.6% versus 17.9%; p<0.001). However, it became weaker as the 10-year ASCVD risk increased (64.2% versus 46.2%; p<0.001, and 74.8% versus 68.7%; p = 0.090). Multivariable analysis demonstrated that male sex was independently associated with CAC progression rate among the entire group (p<0.001). Subgroup analyses showed an independent association between male sex and CAC progression rate only in the low-risk group. The CAC progression rate is higher in men than in women. However, the difference between women and men diminishes as the 10-year ASCVD risk increases.

scholarly journals Renal Function and Risk of Arterial Thrombotic Events in Patients Positive for Lupus Anticoagulant

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 290-290
Author(s):  
Meaghan Colling ◽  
Florian Posch ◽  
Silvia Koder ◽  
Peter Quehenberger ◽  
Cihan Ay ◽  
...  
Keyword(s):  
Risk Factors ◽  
Renal Function ◽  
Lupus Anticoagulant ◽  
Research Funding ◽  
Prior History ◽  
Thromboembolic Events ◽  
Active Smoking ◽  
History Of ◽  
Prospective Risk

Abstract Background: Patients with lupus anticoagulant (LA) are at risk for arterial and venous thromboembolic events. Recent work suggests that LA positive patients who experience thrombotic events in different vascular beds constitute distinct subgroups. To risk stratify patients, further work is needed to better characterize predictors for thromboembolic events in these subgroups. Aims: The aim of this study was to identify baseline characteristics and laboratory parameters associated with the development of arterial or venous thrombotic events. Methods: Patients with at least 2 previous positive LA tests were serially monitored for thrombotic events within the prospective Vienna Lupus Anticoagulant and Thrombosis Study (LATS). Patients without clinical follow-up were excluded from this analysis. Statistical analysis was performed with RStudio (Version 1.1.442). Results: One-hundred-eighty-seven patients were followed (Table 1) for a median of 11.4 years and 1865 follow-up visits (median visit/patient=9). Fifty-seven prospective thrombotic events (TE), including 27 arterial thrombotic events (ATE) and 30 venous thrombotic events (VTE), were observed. This corresponded to 10-year prospective ATE, VTE and overall thrombosis incidences of 13.9% [95%CI: 8.3, 19.6], 18.8% [12.2, 25.4], and 32.0% [24.1, 39.8], respectively. (Figure 1). Thirty-seven of the 57 events occurred in patients with a prior history of thrombosis ("recurrent thrombosis"). In univariable competing risk analysis, age (subdistribution hazard ratio (SHR) = 1.02, 95% CI: 1.00-1.05, p=0.019), body mass index (BMI, 1.05, 1.00-1.11, p=0.042), history of ATE (3.14, 1.45-6.81, p=0.0038), active smoking (2.16, 1.00-4.62, p=0.049), diabetes (4.16, 1.47-11.8, p=0.0073), VKA use at baseline (0.42, 0.18-0.97, p=0.042), aCL IgM positivity (2.48, 1.05-5.83, p=0.038), aβ 2GPI IgM positivity (2.86, 1.18-6.93, p=0.020), mean platelet volume (1.17, 1.06- 1.30, p=0.0024), creatinine (3.76, 1.32- 10.7, p=0.013), and estimate glomerular filtration rate (eGFR, 0.98, 0.96-0.99, p=0.0011) were associated with prospective risk of ATE (Table 2). Conversely, the prospective risk of VTE was univariably associated only with prior history of VTE (3.26, 1.40-7.68, p=0.0061). After adjusting for traditional arterial thrombotic risk factors (age, sex, BMI, active smoking, diabetes,), history of ATE (SHR = 3.97, 95% CI: 1.71-9.025, p=0.0014), prior history of both ATE and VTE (3.87, 1.06-14.16, p=0.041), creatinine (3.93, 1.22-12.66, p=0.022), and eGFR (CKD-EPI, 0.96, 0.96-0.99, p=0.0037) remained independently associated with prospective risk of ATE (Table 2). In detail, the 10-year cumulative risk of ATE was 24.9% [95%CI: 8.8, 41.0], 15.0% [5.8, 24.2], and 6.7% [2.2, 13.8] in patients with a baseline eGFR less than 60 mL/min/1.73m 2, between 60 and 89 mL/min/1.73m 2, and greater than or equal to 90 mL/min/1.73m 2, respectively (Gray's test, p=0.019, Figure 2). Conclusion: Approximately 14% of patients persistently positive for LA experienced an ATE over 10 years. After adjusting for traditional arterial risk factors, decreased renal function was associated with an increased prospective risk of ATE. Notably, decreased renal function was not associated with development of VTE and the association with ATE was also independent of underlying SLE, LLD, or rheumatic disease (data not shown). Clinically, LA positive patients with decreased renal function may represent a subgroup that might benefit from more aggressive anti-thrombotic therapy or anti-thrombotic prophylaxis. Figure 1 Figure 1. Disclosures Pabinger: Bayer: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Daiichi Sanchyo: Consultancy, Honoraria; Alexion: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; NovoNordisk: Consultancy, Research Funding; CSL Behring: Consultancy, Honoraria, Research Funding.

Retrospective Analysis on 290 Patients with Polycythemia Vera Referred to a Single Transfusion Centre: Diagnosis Revision According to WHO Criteria and Evaluation of Survival and Complications According to Prognostic Factors and Treatment

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5229-5229
Author(s):  
Ermanno Venturino ◽  
Dario Ferrero ◽  
Elena Crisà ◽  
Mario Bazzan ◽  
Ausilia Ciocca ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Diagnostic Criteria ◽  
Risk Group ◽  
Thrombotic Risk ◽  
Free Survival ◽  
Cytoreductive Treatment ◽  
History Of

Abstract Polycythemia vera (PV) is a myeloproliferative disorder strongly related to a mutated state of JAK2 tyrosine kynase. Several guide-lines have been published on diagnostic criteria and disease management. However, it is not well known if these recommendations are actually followed in the common clinical practice. Moreover, the recent large ECLAP study (Di Nisio et al.: Br J Haematol 2007) questioned the former strong recommendation of keeping the hematocrit (Hct) value below 0.45. We analysed 290 patients with a PV diagnosis made from January 1995 to December 2006 in different hematological institutions and referred to a single transfusion centre for phlebotomy. Among the whole casistics, 210 patients only satisfied 2001 or 2007 WHO diagnostic criteria for PV. This selected group of patients underwent further evaluation of clinical outcome. JAK2 V617F mutation was found in 80/83 of these patients. Median follow up from diagnosis was 68 months (range 13–161). The 210 patients included 115 males and 95 females with a median age of 65 years (range 18–92). Known risk factors at diagnosis comprehended history of previous thrombosis in 34 and concomitant cardiovascular risk factors (diabetes, smoking habit, hypertension, dyslipidemia) in 124 patients. According to the thrombotic risk stratification (Finazzi et al.: Blood 2005), 36 patients were in the low risk group, 29 in the intermediate one and 145 in the high risk group. All patients received phlebotomy at least in the first month from diagnosis. Eighty patients proceeded with phlebotomy only, whereas 130 also received a cytoreductive treatment for at least 6 months. Almost all patients (205: 98%) received either anti-platelets (195) and/or anti-coagulant (30) therapy. The main cytoreductive treatment was hydroxyurea (HU), used by 127 (97%) patients. In particular, HU was the only cytoreductive agent for 107 patients. Other drugs included pipobroman (18 patients), busulfan (5 patients), alpha interferon (2 patients) and 6-thioguanine (1 patient), used for intolerance or suboptimal response to HU. A thrombotic event was observed at diagnosis in 21 patients (10%). A correlation was observed between thrombosis at diagnosis and both thrombocytosis &gt; 600 × 109/l (p: &lt;0.001) and known cardiovascular risk factors (p: 0.03). During follow-up, seventeen patients died. Survival rate was 91.5% at the median follow-up of 68 months and is projected to reach 84% at 13 years. Overall survival was negatively influenced by age at diagnosis &gt; 65 years (p: &lt; 0.001), history of thrombosis before diagnosis (p: 0.05) and high risk score according to thrombotic risk stratification (p: 0.05). Forty-five patients (21%) displayed post-diagnosis thrombotic events at a median time of 41 months, which correlated to age at diagnosis &gt; 65 years (p: 0.006) and high thrombotic risk score (p: 0.04). Leukemic evolution occurred in 4 patients (2%), while secondary myelofibrosis and non-hematological neoplasia were observed in 8 and 11 patients, respectively. Chemotherapy administration did not affect neither overall nor thrombosis-free survival but correlated to neoplastic events (p: 0.05). Median Hct during follow up was kept at the recommended value &lt; 0.45 in 31 patients only (15%). Sixty-three % of patients maintained a median Hct value between 0.45 and 0.48 whereas 21.5 % had median Hct value &gt; 0.48. A Hct value &lt; 0.48 positively affected overall (p: 0.02) but not thrombosis-free survival. A possible advantage of keeping Hct value &lt; 0.45 could not be demonstrated due to the small number of patients in this group. In conclusion, diagnostic procedures were not found adherent to WHO indications in 80/290 (27%) patients with hypothetical PV diagnosis and in most of patients the Hct value could not be maintained below the recommended value. The importance of JAK2 evaluation as a diagnostic criteria was further underlined by the detection of V617F mutation in 96 % of the screened patients with a confirmed diagnosis of PV. Our casistics confirmed the role of known prognostic factors as age, previous thrombosis or concomitant cardiovascular risk factors, while the optimal Hct value during follow up (&lt; 0.45 or &lt; 0.48) and the true advantage of cytoreductive treatments remain to be established.

Application of the International Prognostic Score of Thrombosis for Essential Thrombocytemia(ET) (IPSET-Thrombosis) in a Cohort of ET Patients: Experience from Gruppo Laziale for Myeloproliferative Ph Negative Neoplasms

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2821-2821
Author(s):  
Michele Cedrone ◽  
Barbara Anaclerico ◽  
Francesca Paoloni ◽  
Roberto Latagliata ◽  
Marco Montanaro ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Risk Group ◽  
Prognostic Score ◽  
High Risk Group ◽  
Thrombotic Risk ◽  
International Prognostic Score ◽  
Essential Thrombocytemia ◽  
Observation Period

Abstract INTRODUCTION: Essential Thrombocytemia (ET) is the most common of the myeloproliferative neoplasms, vascular complications contribute mostly to both morbidity and mortality. The ability to identify thrombotic risk of the individual patient is necessary for a correct therapeutic management. Traditionally, risk stratification for thrombosis in ET pts was based on the respective absence and/or presence of either age >60 years or history of thrombosis. Recently, the IPSET score (International Prognostic Score Of Thrombosis for ET) was developed to better predict the occurrence of thrombotic events in ET patients. Risk factors included in the new score were: age, cardiovascular risk factors, previous thrombosis, presence of JAK 2 V617F mutation. AIM: to evaluate the validity of IPSET-thrombosis score in a cohort of ET patients from "Gruppo Laziale for Myeloproliferative Ph negative Neoplasms" in predicting thrombosis incidence. METHODS: from January 1978 to December 2011 we observed 1249 ET patients, median follow up was 105 months (range 12.1-417.7). We were able to retrospectively evaluate all the IPSET risk factors in 680 ET patients and estimated the clinical implication of the IPSET-thrombosis score system. According to the score 27.3 %, 19.1% and 53.5% of pts were stratified in low, intermediate and high risk group respectively. RESULTS: median age at the time of diagnosis was 61.8 yrs (range 19.9 -94; 64% females), median hemoglobin was 14 g/dl (range 6-20); median leukocyte count was 8.8 x 109/L (range 1,2-57); median platelets count was 812x 109/L (range 108-3582). We observed, during a median follow-up of 200 months, 82 thrombotic events (total incidence 17,89 %). According IPSET-thrombosis risk, in our ET population was documented a statistically different thrombosis free survival (TFS) (Gray test 0.1316): 85%, 78%, 77% in low,intermediate and high risk group respectively. During all the observation period the intermediate and high risk group showed a similar probability of thrombotic events. CONCLUSIONS: in our retrospective study the IPSET score was able to differentiate the rate of thrombosis events in low-risk (0-1 risk factors) from that of intermediate (>= 2 risk factors) and high risk (>= 3 risk factors) ET pts. Unfortunately the intermediate and high risk groups show a similar incidence of thrombotic events during the whole observation period. We were not able to verify the clinical benefit resulting from the different treatment strategies. Because treatment options in ET pts are tailored according to thrombotic risk, and since we have specified therapeutic indications for patients with low and high risk, it is necessary to validate the score IPSET in a large prospective, long term study to discriminate a true "intermediate" subset of patients for which there are no currently defined therapeutic guidelines. Disclosures No relevant conflicts of interest to declare.

Abstract 4985: Are All Patients Considered “Low Risk” for Coronary Heart Disease Really Low Risk? An Analysis from the Atherosclerosis Risk in Communities (ARIC) Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Vijay Nambi ◽  
Lloyd Chambless ◽  
Aaron R Folsom ◽  
Yijuan Hu ◽  
Tom Mosley ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Risk Group ◽  
Low Risk ◽  
Lipid Lowering ◽  
Chd Risk ◽  
The Absolute ◽  
Event Rates ◽  
Aric Study

Low risk for coronary heart disease (CHD) is defined by ATP III as a 10 year risk of <10%. There have been suggestions, however, that a 10 year CHD risk of 5–10% be considered as intermediate risk. The addition of carotid intima media thickness (CIMT) has been shown to improve CHD risk prediction when added to traditional risk factors (TRF) (age, gender, high density lipoprotein cholesterol, total cholesterol, diabetes, hypertension and cigarette smoking) in the ARIC study. We investigated the absolute event rates with and without the addition of CIMT to TRF in the ARIC study and determined the impact in the 0–10% risk group. Participants in the ARIC study (n=13145) without baseline CHD or stroke and with CIMT measurements available were included for this analysis. Using Cox proportional hazards models the participants were classified into various risk categories using TRF and further classified by sex specific CIMT (categorized as <25 th , 25 th to 75 th and >75 th percentile). The absolute event rates were then described in each group (table ). Over a mean follow up of 13.8 years, 1601 (12.2%) individuals had incident CHD events. Approximately 31% of these incident CHD events were in the 5–10% risk group which made up 28% of the study while only 16% of the incident CHD events occurred in the 0–5% risk group which made up 47% of the study population. The 5–10% group had event rates (13.7%) greater than the study average (12.2%), especially in those with thicker CIMT (>75 th percentile, event rate 17%), and greater event rates than those in the 0–5% risk group (4.1%) (table ). Given the notably higher observed CHD risk in the 5–10% group (especially in those with thicker CIMT) relative to the 0–5% group, the availability of safe, low cost lipid lowering medications and low risk tests such as ultrasound that may improve risk stratification, it may be time to evaluate the low risk group more carefully for cardiovascular preventive therapies. Table. Incident CHD in the various risk groups over a mean follow up of 13.8 years in the ARIC study

Abstract 19763: Role of HAS-BLED Score on Major Bleeding in Atrial Fibrillation Undergoing Percutaneous Coronary Intervention With Drug-eluting Stents

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Yoshitaka Ito ◽  
Kazuhiro Naito ◽  
Katsuhisa Waseda ◽  
Hiroaki Takashima ◽  
Akiyoshi Kurita ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Stent Implantation ◽  
Risk Group ◽  
High Risk Group ◽  
Low Risk

Background: While anticoagulant therapy is standard management for atrial fibrillation (Af), dual antiplatelet therapy (DAPT) is needed after stent implantation for coronary artery disease. HAS-BLED score estimates risk of major bleeding for patients on anticoagulation to assess risk-benefit in Af care. However, it is little known about usefulness of HAS-BLED score in Af patient treated with coronary stents requiring DAPT or DAPT plus warfarin (triple therapy: TT). The aim of this study was to evaluate the role of HAS-BLED score on major bleeding in Af patients undergoing DAPT or TT. Methods: A total of 837 consecutive patients were received PCI in our hospital from Jan. 2007 to Dec. 2010, and 66 patients had Af or paroxysmal Af at the time of PCI. Clinical events including major bleeding (cerebral or gastrointestinal bleeding) were investigated up to 3 years. Patients were divided into 2 groups based on HAS-BLED score (High-risk group: HAS-BLED score≥4, n=19 and Low-risk group: HAS-BLED score<4, n=47). DAPT therapy was required for a minimum 12 months after stent implantation and warfarin was prescribed based on physicians’ discretion. Management/change of antiplatelet and anticoagulant therapy during follow-up periods were also up to physicians’ discretion. Results: Baseline characteristics were not different between High-risk and Low-risk group except for age. Overall incidence of major bleeding was observed in 8 cases (12.1%) at 3 years follow-up. Major bleeding event was significantly higher in High-risk group compared with Low-risk group (31.6% vs. 4.3%, p=0.002). However, management of DAPT and TT was not different between the 2 groups. Among component of HAS-BLED score, renal dysfunction and bleeding contributed with increased number of the score. Conclusion: High-risk group was more frequently observed major bleeding events compared with Low-risk group in patients with Af following DES implantation regardless of antiplatelet/anticoagulant therapy.

Antiphospholipid Antibody Profile Stability Over Time: Prospective Results from APS ACTION Clinical Database and Repository

2020 ◽  
pp. jrheum.200513
Author(s):  
Elena Gkrouzman ◽  
Ecem Sevim ◽  
Jackie Finik ◽  
Danieli Andrade ◽  
Vittorio Pengo ◽  
...  
Keyword(s):  
Multivariable Analysis ◽  
Primary Objective ◽  
Antiphospholipid Antibody ◽  
Long Term Outcomes ◽  
Glycoprotein I ◽  
Baseline Characteristics ◽  
Stored Blood ◽  
Over Time

Objective APS ACTION Registry studies long-term outcomes in persistently antiphospholipid antibody (aPL)-positive patients. Our primary objective was to determine whether clinically meaningful aPL profiles at baseline remain stable over time. Our secondary objectives were to determine a) whether baseline characteristics differ between patients with stable and unstable aPL profiles, and b) predictors of unstable aPL profiles over time. Methods Clinically meaningful aPL profile was defined as positive lupus anticoagulant (LA) test and/or anticardiolipin (aCL)/anti-β2 glycoprotein-I (aβ2GPI) IgG/M ≥40 U. Stable aPL profile was defined as a clinically meaningful aPL profile in at least two-thirds of follow-up measurements. Generalized linear mixed models with logit link were used for primary objective analysis. Results Of 472 patients with clinically meaningful aPL profile at baseline (median follow up: 5.1 years), 366/472 (78%) patients had stable aPL profiles over time, 54 (11%) unstable; and 52 (11%) inconclusive. Time did not significantly affect odds of maintaining a clinically meaningful aPL profile at follow-up in univariate (p=0.906) and multivariable analysis (p=0.790). Baseline triple aPL positivity decreased (Odds Ratio [OR] 0.25, 95% Confidence Interval [CI] 0.10-0.64, p=0.004) and isolated LA test positivity increased (OR 3.3, 95% CI 1.53-7.13, p=0.002) the odds of an unstable aPL profile over time. Conclusion Approximately 80% of our international cohort patients with clinically meaningful aPL profile at baseline maintain such at a median follow-up of five years; triple aPL-positivity increase the odds of a stable aPL profile. These results will guide future validation studies of stored blood samples through APS ACTION Core Laboratories.

P9 Novel use of CHA2DS2VASC score to select patients to undergo repeat atrial fibrillation screening

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
W Sun ◽  
B P Y Yan
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Clinical Outcomes ◽  
Cross Validation ◽  
Risk Group ◽  
Curve Analysis ◽  
Low Risk ◽  
Decision Curve Analysis ◽  
Risk Patients

Abstract Background We have previously demonstrated unselected screening for atrial fibrillation (AF) in patients ≥65 years old in an out-patient setting yielded 1-2% new AF each time screen-negative patients underwent repeated screening at 12 to 18 month interval. Selection criteria to identify high-risk patients for repeated AF screening may be more efficient than repeat screening on all patients. Aims This study aimed to validate CHA2DS2VASC score as a predictive model to select target population for repeat AF screening. Methods 17,745 consecutive patients underwent 24,363 index AF screening (26.9% patients underwent repeated screening) using a handheld single-lead ECG (AliveCor) from Dec 2014 to Dec 2017 (NCT02409654). Adverse clinical outcomes to be predicted included (i) new AF detection by repeated screening; (ii) new AF clinically diagnosed during follow-up and (ii) ischemic stroke/transient ischemic attack (TIA) during follow-up. Performance evaluation and validation of CHA2DS2VASC score as a prediction model was based on 15,732 subjects, 35,643 person-years of follow-up and 765 outcomes. Internal validation was conducted by method of k-fold cross-validation (k = n = 15,732, i.e., Leave-One-Out cross-validation). Performance measures included c-index for discriminatory ability and decision curve analysis for clinical utility. Risk groups were defined as ≤1, 2-3, or ≥4 for CHA2DS2VASC scores. Calibration was assessed by comparing proportions of actual observed events. Results CHA2DS2VASC scores achieved acceptable discrimination with c-index of 0.762 (95%CI: 0.746-0.777) for derivation and 0.703 for cross-validation. Decision curve analysis showed the use of CHA2DS2VASC to select patients for rescreening was superior to rescreening all or no patients in terms of net benefit across all reasonable threshold probability (Figure 1, left). Predicted and observed probabilities of adverse clinical outcomes progressively increased with increasing CHA2DS2VASC score (Figure 1, right): 0.7% outcome events in low-risk group (CHA2DS2VASC ≤1, predicted prob. ≤0.86%), 3.5% intermediate-risk group (CHA2DS2VASC 2-3, predicted prob. 2.62%-4.43%) and 11.3% in high-risk group (CHA2DS2VASC ≥4, predicted prob. ≥8.50%). The odds ratio for outcome events were 4.88 (95%CI: 3.43-6.96) for intermediate-versus-low risk group, and 17.37 (95%CI: 12.36-24.42) for high-versus-low risk group.  Conclusion Repeat AF screening on high-risk population may be more efficient than rescreening all screen-negative individuals. CHA2DS2VASC scores may be used as a selection tool to identify high-risk patients to undergo repeat AF screening. Abstract P9 Figure 1

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