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  • 1
    Publication Date: 2019-11-13
    Description: Introduction: There are multiple mechanisms of occurrence of TMA. Some of the etiologies are associated with high morbidity and mortality, but there are very subtle differences in presentation. A high index of suspicion is recommended for thrombotic thrombocytopenic purpura (TTP) due to the time sensitive nature of treatment initiation and poor outcomes associated with delay in treatment. Due to this, treatment with PLEX is often initiated empirically before diagnostic test results are available. We aim to report the management and outcomes of TMA along with the predictive value of the PLASMIC score in our patient population, over a 10-year period in an inner-city safety net hospital. Methods: This is a single center observational study including patients who underwent PLEX for a diagnosis of TMA, due to concern for TTP between January 2009 and May 2019 at an inner-city safety net hospital. Patients were identified from blood bank records and data was collected by review of electronic medical record. We excluded patients 5 and 70.83% had a score ≥5 at the time of presentation. Among non-TTP TMA, 25% had a score of 〉5 and 62.5% had a score ≥5. The sensitivity, specificity and positive predictive value of PLASMIC score for prediction of final diagnosis of TTP was calculated for all patients who met inclusion criteria and is shown in the attached table. Of those who underwent PLEX in the setting of TMA for the concern of TTP, only about a third were started on PLEX within 24 hours. Conclusion:Among our study population, only about a third were started on PLEX within 24 hours which is concerning and highlights the need for quality improvement initiatives to increase provider awareness and decrease time to PLEX. Final diagnosis of TTP was made in 62.5% of the patients but notably, the performance of PLASMIC score in our patient population was inferior compared to prior validation studies. One possible explanation for this could be the difference in baseline patient demographics, with our patients belonging mostly to minority groups. There is a need for further studies with derivation and validation cohorts in this patient population to derive a scoring system that is more predictive. Table Disclosures No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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  • 2
    Publication Date: 2018-11-29
    Description: Introduction: Rivaroxaban is a target specific oral anticoagulant approved for treatment of deep venous thromboembolism (DVT), pulmonary embolism (PE) and risk reduction in patients with DVT/PE requiring continued anticoagulation. The XALIA study showed a reduced bleeding risk compared to standard anticoagulation therapy; however, there is paucity of data regarding correlates of bleeding risk amongst patients receiving rivaroxaban in the community setting. We aimed to investigate the clinical factors associated with bleeding events (BE) in patients receiving rivaroxaban for treatment of DVT/PE. Methods: A retrospective study was conducted at John H. Stroger, Jr. Hospital of Cook County. We screened the charts of 837 patients who received rivaroxaban from January 1, 2015 to April 01, 2018. Patients with DVT/PE were included in the study (n=271). Patients with atrial fibrillation and those receiving rivaroxaban for prophylaxis were excluded. Any reported BE was recorded as either major or minor bleeding event. Major BE was defined as events requiring hospitalization, blood transfusions or significant drop in hemoglobin (〉2gm/dL). Rest of the BE were classified as minor BE. Socio-demographic and clinical factors were collected. Chi-square test and fisher exact test were used as the tests of trend. Multivariate logistic regression models were used to quantify the independent predictors. Odds ratios (OR) and adjusted odds ratios (aOR) with 95% confidence intervals (CI) were obtained. Results: The study included 271 patients, of which 68.3% were African-American, 14.4% were Caucasian, and 12.9% were Hispanic. Median age was 53 years and 60.9% patients were men. Bleeding events were reported in 11.4% (n=31) patients with 6.3% major bleeding events and 5.2% minor bleeding events. Only concurrent use of aspirin (23.8% vs. 9.2%; OR 3.10, 95% CI 1.34-7.17, P = 0.008) was significantly associated with bleeding events. None of the clinical parameters, like abnormal liver function tests (11.4%), cirrhosis (3.3%), chronic kidney disease stage 3 or worse (7.6%), prior use of warfarin (29.9%) or low molecular weight heparin (18.1%) were associated with bleeding events. In multivariate model adjusted for age, gender and race, concurrent use of aspirin (aOR 3.06, 95% CI 1.23-7.62, P = 0.017) remained independent predictor of bleeding events. Conclusion: In the community practice, aspirin (81mg or 325mg) is prescribed for cardio-protection. A recently concluded trial showed a better cardioprotective effect of combining rivaroxaban and aspirin, without increase in BE in patients with stable cardiovascular disease. However, such data is not evident in patients receiving rivaroxaban for DVT/PE. Our study shows an increased rate of bleeding events in such patients with concurrent use of aspirin. Our study population comprises of two-third African-American patients who are under-represented in the clinical trials. Based on our results we would suggest further investigation in safety of prescribing aspirin with rivaroxaban in patients with DVT/PE in prospective trials. Disclosures No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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  • 3
    Publication Date: 2019-11-13
    Description: Introduction: Current expert recommendations recommend double therapy (DT) over triple therapy (TT) in atrial fibrillation patients post percutaneous coronary intervention (PCI) to prevent the incidence of stroke. Though previous studies have focused on DT (oral anticoagulant [OAC] + P2Y12 inhibitor (including clopidogrel, ticagrelor and prasugrel)) versus TT (OAC + P2Y12 inhibitor and aspirin) strategy, no study assessed which OAC was more effective in the prevention of cardiovascular events and stroke. To this end we performed a systematic review and meta-analysis to assess whether non-vitamin K oral anticoagulants (NOAC) based DT strategy is comparable with vitamin K antagonist-based TT in patients with AF after PCI. Methods: Embase, Ovid, Pubmed and Scopus were extensively searched for only phase 2 and 3 clinical trials comparing NOAC based DT with VKA based TT from inception of these databases till June 2019 by two independent reviewers. The endpoints were all-cause mortality, Thrombolysis in Myocardial Infarction (TIMI) major bleeding, cardiovascular mortality and myocardial infarction. Cochrane Collaboration's tool was used for risk of bias assessment. Statistical heterogeneity was quantified using I2 statistics. Publication bias was assessed with Eggers regression test. Estimates were reported as hazard ratios (HR) with 95% confidence intervals (CI) using random effect model. Rivaroxaban 15 mg once daily dose from PIONEER-AF was included. From REDUAL-PCI trial we included dabigatran 110 mg BID and 150 mg BID doses. AUGUSTUS trial used 5 mg BID or 2.5 mg BID dosing of apixaban. Results: 402 trials were retrieved in the initial search which were analyzed according to PRISMA (Preferred Reporting Items for Systematic review and Meta-Analyses) guidelines. Three trials (Augustus, PIONEER AF-PCI and RE-DUAL PCI) were extracted that met the inclusion criteria and included in the final analysis evaluating 8754 patients. Twenty seven percent were females. Mean age was 71 years. PCI was done for acute coronary syndrome in 44% of the patients. Mean calculated CHA2DS2-VASc was 4 which qualifies the use of oral anticoagulants. Only PIONEER AF-PCI and RE-DUAL PCI trials described the type of stent used for PCI. Drug eluting stents were used in 71% of the patients. There was no evidence of publication bias in our analysis (P=.78). The studies overall had low risk of bias. Our analysis showed no statistically significant difference in usage of NOAC + P2Y12 inhibitor compared to triple therapy consisting vitamin K antagonist in regards to all-cause mortality, (HR 0.92, 95% CI 0.72-1.18, P=.52), thrombolysis in myocardial infarction (TIMI) major bleeding (HR 0.91, 95% CI 0.38-2.16, P=.83), cardiovascular mortality (HR 0.95, 95% CI 0.71-1.28, P=.75), stroke (HR 1.07, 95% CI 0.67-1.71, P=.78),stent thrombosis (HR 0.72, 95% CI 0.42-1.23, P=0.23) and myocardial infarction (HR 0.88, 95% CI 0.68-1.13, P=.32). Conclusion: We conclude that there is no difference between the usage of NOAC including rivaroxaban, dabigatran and apixaban in dual regimen vs triple therapy with VKA (warfarin). However, some limitations need to be considered such as heterogeneity across patients in terms of indication for PCI (elective vs emergency), choice of P2Y12 inhibitor (clopidogrel vs ticagrelor vs prasugrel), mean duration of therapy (range 6-12 months) and mean length of follow-up (range 6-14 months). In future clinical practice, post-PCI antithrombotic regimens in AF will likely consist of a single P2Y12 inhibitor plus NOAC. Disclosures No relevant conflicts of interest to declare.
    Print ISSN: 0006-4971
    Electronic ISSN: 1528-0020
    Topics: Biology , Medicine
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