scholarly journals Associations of Atrial Fibrillation Patterns With Mortality and Cardiovascular Events: Implications of the MISOAC-AF Trial

2022 ◽  
Vol 27 ◽  
pp. 107424842110694
Author(s):  
Amalia Baroutidou ◽  
Anastasios Kartas ◽  
Athanasios Samaras ◽  
Andreas S. Papazoglou ◽  
Eleni Vrana ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cox Regression ◽  
Bleeding Events ◽  
Mortality And Morbidity ◽  
Hospitalization Rates ◽  
Kaplan Meier ◽  
Prognostic Implications ◽  
Post Hoc

Aim: This retrospective cohort study aimed to evaluate the prognostic implications of the distinct atrial fibrillation (AF) temporal patterns: first diagnosed, paroxysmal, and persistent or permanent AF. Methods: In this post hoc analysis of the MISOAC-AF trial (NCT02941978), a total of 1052 patients with AF (median age 76 years), discharged from the cardiology ward between 2015 and 2018, were analyzed. Kaplan-Meier and Cox-regression analyses were performed to compare the primary outcome of all-cause mortality, the secondary outcomes of stroke, major bleeding and the composite outcome of cardiovascular (CV) mortality or hospitalization among AF patterns. Results: Of patients, 121 (11.2%) had first diagnosed, 356 (33%) paroxysmal, and 575 (53.2%) persistent or permanent AF. During a median follow-up of 31 months (interquartile range 10 to 52 months), 37.3% of patients died. Compared with paroxysmal AF, patients with persistent or permanent AF had higher mortality rates (adjusted hazard ratio (aHR), 1.37; 95% confidence interval [CI], 1.08-1.74, P = .009), but similar CV mortality or hospitalization rates (aHR, 1.09; 95% CI, 0.91-1.31, P = .35). Compared with first diagnosed AF, patients with persistent or permanent AF had similar mortality (aHR, 1.26; 95% CI, 0.87-1.82, P = .24), but higher CV mortality or hospitalization rates (aHR, 1.35; 95% CI, 1.01-1.8, P = .04). Stroke and major bleeding events did not differ across AF patterns (all P > .05). Conclusions: In conclusion, in recently hospitalized patients with comorbid AF, the presence of persistent or permanent AF was associated with a higher incidence of mortality and morbidity compared with paroxysmal and first diagnosed AF.

Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Benjamin A Steinberg ◽  
DaJuanicia N Simon ◽  
Laine Thomas ◽  
Jack Ansell ◽  
Gregg C Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Recurrent Bleeding ◽  
Bleeding Events ◽  
Reversal Agents ◽  
Major Bleeding Events

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.

P4742Evaluation of the HAS-BLED, ATRIA and ORBIT bleeding risk scores in newly diagnosed non-valvular atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Bergamaschi ◽  
A Stefanizzi ◽  
M Coriano ◽  
P Paolisso ◽  
I Magnani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Independent Predictor ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Newly Diagnosed ◽  
Bleeding Events ◽  
Hemorrhagic Events ◽  
Major Bleeding Events

Abstract Background Several risk scores have been proposed to assess the bleeding risk in patients with Atrial Fibrillation. Purpose To compare the efficacy of HAS-BLED, ATRIA and ORBIT scores to predict major bleedings in newly diagnosed non-valvular AF (NV-AF) treated with vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Methods We analyzed all consecutive patients with AF at our outpatient clinic from January to December 2017. Only those with new diagnosed NV-AF starting new anticoagulant therapy were enrolled. Major hemorrhagic events were defined according to the ISTH definition in non-surgical patients. Results Out of the 820 patients admitted with AF, 305 were newly diagnosed with NV-AF starting oral anticoagulation. Overall, 51.3% were male with a mean age of 72.6±13.7 years. Thirty-six patients (11.8%) started VKAs whereas 269 (88.2%) patients were treated with NOACs. The median follow-up time was 10.4±3.4 months. During follow-up, 123 (32.2%) bleeding events were recorded, 21 (17,1%) in the VKA group and 102 (82,9%) in the NOAC group. Eleven (2.9%) major bleeding events occurred: 5 (45.5%) in the VKA group and 6 (54.5%) in the NOAC group. Overall, patients with major hemorrhagic events showed a mean value of the scores significantly higher when compared to patients without such bleeding complications (HASBLED 3.4 vs 2.4 p=0.007; ATRIA 5.6 vs 2.4 p<0.001; ORBIT 3.6 vs 1.8 p<0,001). Conversely, when analyzing the VKA subgroup, only the ATRIA score was significantly higher in patients with major adverse events (7.4 vs 3.5 p<0.001; HAS-BLED: 4.4 vs 3.6 p=0.27; ORBIT 4.4 vs 2.9 p=0.13). An ATRIA score ≥4 identified patients at high risk of bleeding (29.4% vs. 0% events. respectively, p=0.04). In the NOAC group, patients with major bleeding events had higher mean values of ATRIA (4.0 vs 2.3 p=0.02) and ORBIT (2.8 vs 1.6 p=0,04) but not the HAS-BLED (2.5 vs 2.3 p=0.57) scores. Similarly, patients on NOACs with an ATRIA score ≥4 had higher rates of major bleedings (8.1% vs. 1.6% p=0,02). Comparing the single elements of the ATRIA score, only glomerular filtration rate <30 ml/min/1.73 mq was associated with major bleedings in the VKA group (p<0.001) whereas, in the NOAC group, anemia was strongly associated with bleeding events (p=0,02). In fact, multivariate analysis in the NOAC group showed that hemoglobin level at admission was an independent predictor for major bleeding events (OR 0.41, 95% CI 0.23–0.75, P=0.003). Conversely, in the VKA group, baseline creatinine level was an independent predictor for these events (OR 12.76, 95% CI 1.6–101.7, P=0.016). Conclusions The ATRIA score showed the best efficacy in predicting major bleeding events. Hemoglobin and creatinine levels at admission were independent predictors for major hemorrhagic events in the NOAC and in the VKA groups, respectively. The latter finding might be helpful in stratifying the hemorrhagic risk at the beginning of treatment.

scholarly journals Atrial Fibrillation Is Associated with Increased Mortality in Patients Presenting with Ventricular Tachyarrhythmias

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Michael Behnes ◽  
Jonas Rusnak ◽  
Gabriel Taton ◽  
Tobias Schupp ◽  
Linda Reiser ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cox Regression ◽  
Ventricular Tachyarrhythmia ◽  
Prognostic Impact ◽  
Ventricular Tachyarrhythmias ◽  
Lv Dysfunction ◽  
Kaplan Meier ◽  
All Cause Mortality

Abstract Heterogenous data about the prognostic impact of atrial fibrillation (AF) in patients with ventricular tachyarrhythmias exist. Therefore, this study evaluates this impact of AF in patients presenting with ventricular tachyarrhythmias. 1,993 consecutive patients presenting with ventricular tachyarrhythmias (i.e. ventricular tachycardia and fibrillation (VT, VF)) on admission at one institution were included (from 2002 until 2016). All medical data of index and follow-up hospitalizations were collected during the complete follow-up period for each patient. Statistics comprised univariable Kaplan-Meier and multivariable Cox regression analyses in the unmatched consecutive cohort and after propensity-score matching for harmonization. The primary prognostic endpoint was long-term all-cause mortality at 2.5 years. AF was present in 31% of patients presenting with index ventricular tachyarrhythmias on admission (70% paroxysmal, 9% persistent, 21% permanent). VT was more common (67% versus 59%; p = 0.001) than VF (33% versus 41%; p = 0.001) in AF compared to non-AF patients. Long-term all-cause mortality at 2.5 years occurred more often in AF compared to non-AF patients (mortality rates 40% versus 24%, log rank p = 0.001; HR = 1.825; 95% CI 1.548–2.153; p = 0.001), which may be attributed to higher rates of all-cause mortality at 30 days, in-hospital mortality and mortality after discharge (p < 0.05) (secondary endpoints). Mortality differences were observed irrespective of index ventricular tachyarrhythmia (VT or VF), LV dysfunction or presence of an ICD. In conclusion, this study identifies AF as an independent predictor of death in patients presenting consecutively with ventricular tachyarrhythmias.

Prognostic implication of KIT mutations in melanoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9049-9049
Author(s):  
Katherine G. Roth ◽  
Emily C. Zabor ◽  
Marta N. Colgan ◽  
Jedd D. Wolchok ◽  
Paul B. Chapman ◽  
...  
Keyword(s):  
Cox Regression ◽  
Chi Square ◽  
Risk Of Death ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Increased Risk ◽  
History Of ◽  
Genetic Subgroup ◽  
Prognostic Implications

9049 Background: The natural history of BRAF and NRAS mutant (mut) melanoma (mel) has been described, but prognostic implications of KIT mut mel have not. Methods: We performed a single-center retrospective review of 180 patients (pts) enriched for mucosal, acral or chronic sun-damaged skin (CSD) mel and screened for KIT, BRAF, and NRAS mut from 4/07 - 4/10 as a part of a phase II imatinib study. Pt/disease characteristics were compared using the Kruskal-Wallis or Chi-square tests. Factors associated with outcomes were assessed by Kaplan-Meier methods and multivariable Cox regression. Results: Median age, 63.7 years; 54.4% male. Primary site: 40% mucosal, 29% acral, 22% CSD, 9% others. Mut rate: 18% KIT, 16% BRAF, 14% NRAS, 52% wild-type (wt). Pathologic subtype differed by genetic subgroup (p<.001) while age, gender, and stage did not (all p>0.05). 18/26 (69%) KIT mut pts received imatinib in the metastatic (met) setting; 6/18 received > 1 other KIT inhibitor. 3/25 (12%) BRAF mut pts received vemurafenib. 8/27 (30%) KIT mut, 4/27 (15%) BRAF mut, 6/20 (30%) NRAS mut, and 6/20 (30%) wt pts received ipilimumab. 149/180 (83%) pts developed mets at a median of 2.15 years (95% CI: 1.72, 2.72). Median follow-up (FU) of pts not developing mets was 3.91 yrs (range: 0.25, 14.34). Older age (HR: 1.02, 95% CI: 1.00, 1.03) and pathologic subtype (mucosal vs CSD HR: 1.70, 95% CI: 1.02, 2.84; non-CSD/unknown vs CSD HR: 2.05, 95% CI: 1.00, 4.21) were associated with increased risk of mets but not with time from mets to death. Of 149 pts who progressed, 123 (83%) died during FU. Median time from met to death was 1.21 years (95% CI: 0.91, 1.67). Median FU from time of mets among those alive at last FU was 2.53 yrs (range: 0.06, 6.85). Mut status including KIT mut was not associated with time to first met or time from met to death. Pts who received ipilimumab from time of first distant met had reduced risk of death (HR: 0.55, 95% CI: 0.36, 0.87) independent of mut status. No impact was observed with KIT inhibition. Conclusions: KIT mut status is not an independent predictor of time to mets or survival in pts with mets. Ipilimumab improved pt outcomes regardless of mut status. The lack of impact of KIT inhibitors is likely due to the heterogeneity of KIT mut in mel but does not preclude efficacy in appropriately selected pts.

Abstract P111: Sex Differences in Rate or Rhythm Control and Outcomes Among Elderly Patients With Atrial Fibrillation

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Vinita Subramanya ◽  
J'Neka S Claxton ◽  
Pamela L Lutsey ◽  
Richard MacLehose ◽  
Alanna M Chamberlain ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Rate Control ◽  
Treatment Strategy ◽  
Cox Regression ◽  
Rhythm Control ◽  
To Receive

Introduction: Women with atrial fibrillation (AF) experience greater symptomatology, worse quality of life, and have a higher risk of stroke as compared to men, but are less likely to receive rhythm control for the treatment of AF. Whether these differences exist in elderly patients with AF, and whether sex modifies the effectiveness of rhythm versus rate control therapy has not been assessed. Methods: We studied 135,850 men and 139,767 women 75 years or older diagnosed with AF in the MarketScan Medicare database between 2007-2015. Rate control was defined as use of rate control medication or atrioventricular node ablation. Rhythm control was defined by use of anti-arrhythmics, catheter ablation or cardioversion. Participants on both rate and rhythm were coded under rhythm control. We used multivariable logistic and Cox regression models to estimate 1) the association of sex and treatment strategy (within 30-day post AF diagnosis and entire follow-up) and, 2) the association of treatment strategy with incident heart failure, stroke and major bleeding. Results: Men were on average (SD) 82.5 (5.2) years old and women 83.8 (5.6) years, respectively. Women were less likely to receive rhythm control treatment as compared to men in the 30-day post AF diagnosis period (22% vs 27%), (OR 0.91, 95% CI 0.88, 0.94) and over the entire duration of follow-up (28% vs 32%) (HR 0.93, 95% CI 0.90, 0.96). Rhythm (vs. rate) control was associated with a higher risk of heart failure in women [HR 1.41, 95% CI 1.34, 1.49] than in men [HR, 1.21 95% CI 1.15, 1.28] (p for multiplicative interaction < 0.001, Table ). Sex did not modify associations between treatment and incident stroke or major bleeding events. Conclusion: Women aged 75 years and older were less likely to be prescribed rhythm control as compared to men, and experienced higher risk of heart failure than men when receiving rhythm (vs rate) control. Future studies will need to delve into the mechanisms underlying these differences.

Abstract 13621: Predictors of Short-term and Long-term Clinical Outcomes After an Acute Atrial Fibrillation or Flutter Admission

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Jia Yi Anna Ne ◽  
Tu Nguyen ◽  
Stuart Thomas ◽  
Joanne Han ◽  
Emma Charlston ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cox Regression ◽  
Primary Diagnosis ◽  
Chronic Obstructive ◽  
Post Discharge ◽  
Obstructive Pulmonary Disease ◽  
Mortality And Morbidity ◽  
Westmead Hospital

Introduction: Atrial fibrillation (AF) is a major cause of mortality and morbidity globally. This study aims to identify predictors of AF-related rehospitalization following an acute AF/flutter admission. Methods: Patients admitted to Westmead Hospital with a primary diagnosis of AF/flutter from 1 May 2014 to 31 May 2018 were included and followed up until 31 May 2019. We defined AF-related rehospitalization as an admission due to recurrent AF/flutter, congestive heart failure, stroke and/or myocardial infarction. Multivariable logistic regression was used to identify independent predictors of 30-day outcomes. Cox regression was used to identify independent predictors of long-term outcomes: first AF-related rehospitalization or all-cause mortality. Results: Of 1664 consecutive patients admitted with AF/flutter, 55.8% were male and the median age was 68.0. At 30 days, 123 (7.4%) had an AF-related readmission (110 for AF/flutter and 13 for other cardiovascular outcomes). During a mean follow-up period of 2.1 ± 1.5 years, 683 (41.0%) of patients had at least one AF-related rehospitalization (38.1%, n=634) or died (2.9%, n=49). Chronic kidney disease (CKD) (OR 1.94, 95% CI 1.07 - 3.50) was an independent predictor of 30-day AF-related rehospitalization. Age (HR 1.01, 95% CI 1.01 - 1.02 for each additional year), initial admission via emergency (HR 1.29, 95% CI 1.08 - 1.54), CKD (HR 1.64, 95% CI 1.24 - 2.18), chronic obstructive pulmonary disease (HR 1.42, 95% CI 1.09 - 1.83) and the presence of additional comorbidities (HR 1.38, 95% CI 1.04 - 1.83) were independent predictors of first AF-related rehospitalization or death (all p <0.05). Conclusion: AF-related rehospitalization is common following an acute AF/flutter admission. AF/flutter patients with comorbidities, particularly renal and pulmonary diseases, are at high risk of readmission. Such patients could be targeted for increased surveillance and additional post-discharge support to prevent readmission.

scholarly journals Cardiovascular outcomes, bleeding risk, and achieved blood pressure in patients on long-term anticoagulation with the thrombin antagonist dabigatran or warfarin: data from the RE-LY trial

2020 ◽  
Vol 41 (30) ◽  
pp. 2848-2859 ◽  
Author(s):  
Michael Böhm ◽  
Martina Brueckmann ◽  
John W Eikelboom ◽  
Michael Ezekowitz ◽  
Mandy Fräßdorf ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
High Risk ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Bleeding Events ◽  
High Risk Patients ◽  
Increased Risk ◽  
Risk Patients

Abstract Aims A J-shaped association of cardiovascular events to achieved systolic (SBP) and diastolic (DBP) blood pressure was shown in high-risk patients. This association on oral anticoagulation is unknown. This analysis from RELY assessed the risks of death, stroke or systemic emboli, and bleeding according to mean achieved SBP and DBP in atrial fibrillation on oral anticoagulation. Methods and results RE-LY patients were followed for 2 years and recruited between 22 December 2005 until 15 December 2007. 18.113 patients were randomized in 951 centres in 54 countries and 18,107 patients with complete blood pressure (BP) data were analysed with a median follow-up of 2.0 years and a complete follow-up in 99.9%. The association between achieved mean SBP and DBP on all-cause death, stroke and systemic embolic events (SSE), major, and any bleeding were explored. On treatment, SBP &gt;140 mmHg and &lt;120 mmHg was associated with all-cause death compared with SBP 120–130 mmHg (reference). For SSE, risk was unchanged at SBP &lt;110 mmHg but increased at 140–160 mmHg (adjusted hazard ratio (HR) 1.81; 1.40–2.33) and SBP ≥160 mmHg (HR 3.35; 2.09–5.36). Major bleeding events were also increased at &lt;110 mmHg and at 110 to &lt;120 mmHg. Interestingly, there was no increased risk of major bleeding at SBP &gt;130 mmHg. Similar patterns were observed for DBP with an increased risk at &lt;70 mmHg (HR 1.55; 1.35–1.78) and &gt;90 mmHg (HR 1.88; 1.43–2.46) for all-cause death compared to 70 to &lt;80 mmHg (reference). Risk for any bleeding was increased at low DBP &lt;70 mmHg (HR 1.46; 1.37–1.56) at DBP 80 to &lt;90 mmHg (HR 1.13; 1.06–1.31) without increased risk at higher achieved DBP. Dabigatran 150 mg twice daily showed an advantage in all patients for all-cause death and SSE and there was an advantage for 110 mg dabigatran twice daily for major bleeding and any bleeding irrespective of SBP or DBP achieved. Similar results were obtained for baseline BP, time-updated BP, and BP as time-varying covariate. Conclusion Low achieved SBP associates with increased risk of death, SSE, and bleeding in patients with atrial fibrillation on oral anticoagulation. Major bleeding events did not occur at higher BP. Low BP might identify high-risk patients not only for death but also for high bleeding risks. Clinical trial registration  ClinicalTrials.gov—Identifier: NCT00262600.

scholarly journals Stroke and Major Bleeding when Switching from Warfarin to Apixaban in Patients with Advanced Chronic Kidney Disease and Prevalent Atrial Fibrillation

2021 ◽  
Author(s):  
Katherine Garlo ◽  
Thomas Mavrakanas ◽  
Wei Wang ◽  
Elisabeth Burdick ◽  
David Charytan
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Major Bleeding ◽  
The United States ◽  
Bleeding Events ◽  
Part D ◽  
Stage 4 ◽  
Ischemic Attack

Abstract Background Apixaban is the most widely used direct oral anticoagulant in patients with chronic kidney disease (CKD). Data on the incidence of stroke and major bleeding after switching from warfarin to apixaban in patients with prevalent atrial fibrillation (AF) and CKD are limited.Methods Warfarin users with stage 4-5 CKD not on dialysis and non-valvular AF prior to Jan 1,2012 were identified from the United States Data Renal System CKD dataset and individuals switching to apixaban from Jan 1,2012 -Dec 31, 2015 were identified. The incidence of stroke (ischemic or hemorrhagic), transient ischemic attack, or systemic thromboembolism and major bleeding events were estimated. Outcomes were compared between individuals switching to apixaban and those continuing warfarin using survival analyses with inverse probability treatment weighting. Individuals were censored at the time of anticoagulation discontinuation, loss of Medicare part D coverage, dialysis, kidney transplant, a 2nd switch in anticoagulant class, or death. Results 1762 individuals with advanced CKD and AF were initially on warfarin; 71 (4.0%) switched to apixaban (57.8% male, mean age 78.2 years (SD ±6.6), 78.9% white, mean CHA2DS2-VASc 5.0 (SD ±1.5), mean HAS-BLED 2.2 (SD ±0.5) and 1691 (96.0%) continued warfarin (47.6% male, mean age 80.1 years (SD ±8.7), 87.9% white, mean CHA2DS2-VASc 5.5 (SD ±1.6), mean HAS-BLED 2.5 (SD ±0.8). The incidence of stroke in the apixaban switch and warfarin continuation groups were 0.02/patient-year (95%CI 0.002-0.12) and 0.06/patient-year (95%CI 0.05-0.07) (p=0.21). Incidence of major bleeding were 0.02/patient-year (95% CI 0.002-0.13) and 0.06 (95% CI 0.03-0.04) (p =0.44) in the switch and warfarin groups, respectively. In adjusted models, the risk of stroke (HR 0.27 (95% CI 0.04-1.99)) and major bleeding (HR 0.41 (95% CI 0.06-3.02)) trended lower in the apixaban switch compared to the warfarin continuation group.Conclusions The incidence and risk of stroke and major bleeding trended lower in individuals with stage 4-5 CKD and prevalent AF who switched from warfarin to apixaban than individuals continuing warfarin. Our findings support a strategy of switching prevalent AF patients with late stage CKD from warfarin to apixaban. Additional studies including a larger number of events with a longer-duration of follow-up are needed to refine effect estimates.

scholarly journals ACTR-13. FINAL RESULTS WITH CHEMORADIOTHERAPY FOR ANAPLASTIC OLIGODENDROGLIAL TUMORS FROM NRG ONCOLOGY/RTOG 9402

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi15-vi15
Author(s):  
Andrew Lassman ◽  
Minhee Won ◽  
J Gregory Cairncross ◽  
Edward Shaw ◽  
Lynn Ashby ◽  
...  
Keyword(s):  
Cox Regression ◽  
Predictive Biomarker ◽  
Idh Mutation ◽  
Organ Function ◽  
Oligodendroglial Tumors ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Post Hoc

Abstract BACKGROUND Adding intensive-procarbazine, lomustine, and vincristine (iPCV) to radiotherapy (RT) prolonged progression-free (PFS) and overall survival (OS) for patients with 1p19q codeleted anaplastic oligodendroglial tumors (AOTs); some benefit was also observed for IDH-mutant non-codeleted cases (Cairncross et al 2013, 2014, 2016). Now, 25 years after study activation, we updated survival, further assessed IDH as a predictive biomarker, and are exploring the benefit from vincristine. METHODS Eligible adults (KPS ≥ 60, adequate end-organ function) were randomized to pre-RT iPCV (4 cycles x 6 weeks each) vs. RT alone, stratified by age (< or ≥ 50), KPS (60–70 or ≥ 80), and level of anaplasia. Histology (anaplastic oligodendroglioma/oligo-astrocytoma required) and biomarkers (IDH and 1p19q, post-hoc) were determined centrally. Survival was estimated by Kaplan-Meier and Hazard Ratios (HRs) by Cox-regression. RESULTS Overall (n=289), median follow-up was 16.4 years vs. 11.3 years at last report. In codeleted cases, 40% randomized to iPCV remained alive vs. 53% at last report; 5, 10, and 14 year-PFS and -OS rates were 62%, 50%, 41% and 70%, 57%, 46%, respectively; and iPCV unequivocally prolonged PFS (median 9.8 vs. 2.9 years, HR 0.46, 95% CI 0.3–0.7, p< 0.001) and OS (median 13.2 vs. 7.3 years, HR 0.61, 95% CI 0.40–0.94; p=0.02). With IDH mutation but without codeletion (n=66), iPCV prolonged PFS (median 2.8 vs. 1.9 years, HR 0.58, 95% CI 0.34–0.99, p=0.046); OS was longer with a trend for significance (median 5.5 vs. 3.3 years, HR 0.6, 95% CI 0.34–1.03, p=0.06) on this underpowered exploratory post-hoc analysis. CONCLUSION For codeleted AOTs, long-term analyses confirmed that pre-RT iPCV produced meaningful and significant prolongations of PFS and OS. With IDH mutation but without codeletion, iPCV significantly prolonged PFS and showed a trend for prolonged OS. The value of vincristine is being assessed. Supported by NCI grants U10CA180868, U10CA180822, U24CA196067, and UG1CA189867.

scholarly journals Assessment of Predicted Rate and Associated Factors of Dabigatran-induced Bleeding Events in Malaysian Patients with Non-Valvular Atrial Fibrillation

2017 ◽  
Vol 20 (1) ◽  
pp. 365 ◽  
Author(s):  
Semira Abdi Beshir ◽  
Lok Bin Yap ◽  
Szyuin Sim ◽  
Kok Han Chee ◽  
Yoke Lin Lo
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Congestive Heart Failure ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Laboratory Test Results ◽  
Major Bleeding Events

Purpose: To assess the predicted rate and the factors associated with bleeding events among patients with non-valvular atrial fibrillation (NVAF) receiving dabigatran therapy. Methods: This retrospective cohort study includes adult patients of two tertiary hospitals in Malaysia. Potential study subjects were identified using pharmacy supply database or novel oral anticoagulant (NOAC) registry. Demographics, clinical data and laboratory test results were extracted from the medical records of the patients or electronic databases. The main outcome measure is the occurrence of a bleeding event. Bleeding events were classified into major bleeding, clinically relevant non-major bleeding, or minor bleeding, according to the International Society on Thrombosis and Haemostasis criteria. We consider clinically relevant non-major bleeding events or major bleeding events as clinically relevant bleeding events. An occurrence of any bleeding event was recorded from the initiation of NOAC therapy until the death of a patient, or the date of permanent discontinuation of NOAC use, or the last day of data collection. The predicted rate of dabigatran-induced bleeding events per 100 patient-years was estimated. Results: During a median follow-up period of 18 months, 73 patients experienced 90 bleeding events. Among these patients, 25 including 4 fatal cases, experienced major bleeding events. The predicted rate per 100 patient-years of follow-up of any bleeding events was 9.0 [95% CI 6.9 to 11.1]; clinically relevant bleeding events 6.0 [95% CI 4.8 to 8.3], and major bleeding events 3.0 [95% CI 1.9 to 4.2]. The independent risk factor for clinically relevant bleeding events is prior bleeding. While prior bleeding or congestive heart failure is linked with major bleeding events. Conclusions: The predicted rate for dabigatran-induced major bleeding episodes is low but these adverse events carry a high fatality risk. Preventive measures should target older patients who have prior bleeding or congestive heart failure. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

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