scholarly journals NOAC Therapy Is Also Effective and Safe in Patients Older Than 80 Years — Results of the Prospective Dresden NOAC Registry (NCT01588119)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 422-422
Author(s):  
Jan Beyer-Westendorf ◽  
Luise Tittl ◽  
Christiane Naue ◽  
Sandra Marten

Abstract Background: Non-vitamin-K-antagonist oral anticoagulants (NOACs) have rapidly become a cornerstone in anticoagulant therapy. However, anticoagulated patients older than 80 years represent an especially challenging population, since their thromboembolic and bleeding risks are excessively high and chronic kidney disease is common, making treatment decisions even more complicated. As a consequence, long-term safety data for this specific population are needed. Patients and methods: Using data from DRESDEN NOAC, a prospective regional registry in Germany in which patients with oral anticoagulation undergo prospective follow-up (FU) by quarterly phone interviews, we assessed rates of thromboembolic and bleeding outcomes in patients older than 80 years, based on centrally adjudicated events using standard outcome definitions. Results: Until 30th November 2017, 3984 patients were enrolled into the registry (53% male, mean age 70.2 years), including 935 patients aged ≥ 80 years (487 [52.1%] received rivaroxaban, 198 [21.2%] apixaban, 165 [17.6%] edoxaban and 85 [9.1%] dabigatran, respectively). Indication for anticoagulant therapy was atrial fibrillation (AF) in 752 (80.4%) cases, venous thromboembolism (VTE) in 179 (19.1%), and other indications in 4 (0.4%) cases. This subset of patients had a mean age of 84.2 years (range 80-100y) and 406 (43.4%) patients were male (Table 1). During a mean follow-up of 970.7 ± 642.2 days (mean NOAC exposure 815.3 ± 644.5 days) an intention-to-treat (all events counted) analysis of all very old patients demonstrated an event rate for the composite endpoint of stroke, TIA, systemic embolism or VTE of 1.0/100 patient-years (95% CI 0.8 - 1.2). In AF patients, the rate for stroke, TIA, systemic embolism was 1.0/100 patient-years (95% CI 0.8 - 1.2) and in VTE patients, the rate for recurrent DVT or PE in VTE patients was 0.4/100 patient-years (95% CI 0.2 - 0.7). In the on-treatment analysis (only on-treatment events counted), the corresponding event rates were 0.7/100 patient-years (95% CI 0.5 - 0.9) for the composite endpoint, 0.7/100 patient-years (95% CI 0.5 - 0.9) for stroke, TIA, systemic embolism in AF patients, and 0.1/100 patient-years (95% CI 0.01 - 0.3) for recurrent VTE in VTE patients, respectively. The overall rate of ISTH major bleeding was 1.0/100 patient-years (95% CI 0.8 - 1.2), with numerically higher rates in SPAF patients (1.2/100 patient-years; 95% CI 0.9 - 1.5) compared to VTE patients (0.4/100 patient-years; 95% CI 0.2 - 0.7). 255 patients died during FU (2.2/100 patient-years; 95% CI 2.0 - 2.5), of which 120 deaths occurred during or within 3 days after last intake of NOAC (1.3/100 patient-years; 95% CI 1.1 - 1.6). Most common causes of death were fatal cardiovascular event (n= 86; consisting of 20 cases of acute coronary syndrome, 19 ischaemic strokes, 17 VTE, 2 systemic embolism and 123 cases of other cardiovascular deaths such as worsening of chronic heart failure, or unexplained deaths ruled as potentially related to cardiovascular events) and age related death (n= 79), followed by sepsis/infection (n= 40), terminal malignant disease (n= 26), fatal bleeding (n= 11) and other causes (n= 13). Overall, after 1800 days of FU, approximately 80% of this very old population were outcome-free survivors, as indicated by the Kaplan Meier curve (figure1). Conclusions: During long-term FU of more than 2.5 years, this very old population of NOAC recipients demonstrated low rates of cardiovascular or major bleeding complications during active NOAC therapy. Approximately one quarter of the study population died during follow-up, with cardiovascular events being the leading cause of death. Only 11 fatal bleeding events were observed; however, most of the 58 fatal thromboembolic events occurred after anticoagulation was discontinued. This indicates that continued anticoagulation with NOACs may result in a beneficial risk-benefit ratio also in very old patients. Disclosures Beyer-Westendorf: Bayer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding. Marten:Bayer: Honoraria; Daiichi Sankyo: Honoraria.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Deshan Yuan ◽  
Sida Jia ◽  
Ce Zhang ◽  
Lin Jiang ◽  
Lianjun Xu ◽  
...  

Abstract Background There are relatively limited data regarding real-world outcomes in very old patients with three-vessel disease (3VD) receiving different therapeutic strategies. This study aimed to perform analysis of long-term clinical outcomes of medical therapy (MT), coronary artery bypass grafting (CABG), and percutaneous coronary intervention (PCI) in this population. Methods We included 711 patients aged ≥ 75 years from a prospective cohort of patients with 3VD. Consecutive enrollment of these patients began from April 2004 to February 2011 at Fu Wai Hospital. Patients were categorized into three groups (MT, n = 296; CABG, n = 129; PCI, n = 286) on the basis of different treatment strategies. Results During a median follow-up of 7.25 years, 262 deaths and 354 major adverse cardiac and cerebrovascular events (MACCE) occurred. Multivariate Cox analysis showed that the risk of cardiac death was significantly lower for CABG compared with PCI (adjusted hazard ratio [HR] = 0.475, 95% confidence interval [CI] 0.232–0.974, P = 0.042). Additionally, MACCE appeared to show a trend towards a better outcome for CABG (adjusted HR = 0.759, 95% CI 0.536–1.074, P = 0.119). Furthermore, CABG was significantly superior in terms of unplanned revascularization (adjusted HR = 0.279, 95% CI 0.079–0.982, P = 0.047) and myocardial infarction (adjusted HR = 0.196, 95% CI 0.043–0.892, P = 0.035). No significant difference in all-cause death between CABG and PCI was observed. MT had a higher risk of cardiac death than PCI (adjusted HR = 1.636, 95% CI 1.092–2.449, P = 0.017). Subgroup analysis showed that there was a significant interaction between treatment strategy (PCI vs. CABG) and sex for MACCE (P = 0.026), with a lower risk in men for CABG compared with that of PCI, but not in women. Conclusions CABG can be performed with reasonable results in very old patients with 3VD. Sex should be taken into consideration in therapeutic decision-making in this population.


Gerontology ◽  
2004 ◽  
Vol 51 (1) ◽  
pp. 62-65 ◽  
Author(s):  
Pierre Pfitzenmeyer ◽  
France Mourey ◽  
Patrick Manckoundia ◽  
Philippe d’Athis

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Cecilie Røe ◽  
Toril Skandsen ◽  
Unn Manskow ◽  
Tiina Ader ◽  
Audny Anke

The aim of the present study was to evaluate mortality and functional outcome in old and very old patients with severe traumatic brain injury (TBI) and compare to the predicted outcome according to the internet based CRASH (Corticosteroid Randomization After Significant Head injury) model based prediction, from the Medical Research Council (MRC).Methods.Prospective, national multicenter study including patients with severe TBI ≥65 years. Predicted mortality and outcome were calculated based on clinical information (CRASH basic) (age, GCS score, and pupil reactivity to light), as well as with additional CT findings (CRASH CT). Observed 14-day mortality and favorable/unfavorable outcome according to the Glasgow Outcome Scale at one year was compared to the predicted outcome according to the CRASH models.Results.97 patients, mean age 75 (SD 7) years, 64% men, were included. Two patients were lost to follow-up; 48 died within 14 days. The predicted versus the observed odds ratio (OR) for mortality was 2.65. Unfavorable outcome (GOSE < 5) was observed at one year follow-up in 72% of patients. The CRASH models predicted unfavorable outcome in all patients.Conclusion.The CRASH model overestimated mortality and unfavorable outcome in old and very old Norwegian patients with severe TBI.


Nosotchu ◽  
2010 ◽  
Vol 32 (3) ◽  
pp. 268-274 ◽  
Author(s):  
Kyoji Tsuda ◽  
Shozo Noguchi ◽  
Eiichi Ishikawa ◽  
Yasunobu Nakai ◽  
Hiroyoshi Akutsu ◽  
...  

1989 ◽  
Vol 75 (1) ◽  
pp. 57-59 ◽  
Author(s):  
Benedetto Busnardo ◽  
Maria Elisa Girelli ◽  
Domenico Rubello ◽  
Maria Rosa Pelizzo ◽  
Natalino Simioni ◽  
...  

Data on a group of 110 patients with differentiated thyroid cancer not treated by radioiodine are reported. Most of them had intrathyroid (stage I) papillary or capsuled follicular cancer of less than 3 cm diameters. They all received thyroxine at TSH suppressive doses. The follow-up ranged between 4 and 25 years, mean 8.7. No patient died of tumor. Two very old patients died free of disease. Four recurrences occurred, within 8 years, all in patients over 45 years, all local or nodal, all papillary, 3 out of 4 after total thyroidectomy. This study shows that radioiodine therapy may be avoided and that lobectomy may be sufficient in patients under 45 years with small papillary or capsuled follicular cancer.


2015 ◽  
Vol 72 (5) ◽  
pp. 466-468
Author(s):  
Dragomir Marisavljevic ◽  
Olivera Markovic ◽  
Radmila Zivkovic

Introduction. There are only a few available data about hairy cell leukemia (HCL) in very old patients. We presented three very different cases of HCL in very old patients diagnosed in a single center and discussed some epidemiological and therapeutical issues in such patients. Case report. The first patient, 89-year-old, had symptomatic cytopenia and achieved sustained complete remission after cladribine treatment. The second patient, 89-year-old, had asymptomatic disease with stable full blood counts during a 3-year follow-up period in which watch-and-wait policy was adopted. The third patient, 82 years old, had two malignancies (HCL and presumably metastatic colorectal carcinoma) and his only treatment were occasional red blood cell transfusions and symptomatic therapy. Conclusion. The presented illustrative examples confirm individualization of treatment is mandatory in very old patients with HCL.


2019 ◽  
Author(s):  
Javier Ortiz-Alonso ◽  
Natalia Bustamante-Ara ◽  
Pedro L. Valenzuela ◽  
María T. Vidán ◽  
Gabriel Rodríguez-Romo ◽  
...  

ABSTRACTObjectiveHospitalisation-associated disability (HAD, defined as the loss of ability to perform one or more basic activities of daily living [ADL] independently at discharge) is a frequent condition among older patients. The present study aimed to assess whether a simple inpatient exercise programme decreases the incidence of HAD in acutely hospitalised very old patients.DesignIn this randomized controlled trial (Activity in GEriatric acute CARe, AGECAR) participants were assigned to a control or intervention (exercise) group, and were assessed at baseline, admission, discharge, and 3 months thereafter.Setting and participants268 patients (mean age 88 years, range 75–102) admitted to an acute care for elders (ACE) unit of a Public Hospital were randomized to a control (n=125) or intervention (exercise) group (n=143).MethodsBoth groups received usual care, and patients in the intervention group also performed simple supervised exercises (walking and rising from a chair, for a total daily duration of ∼20 min). We measured incident HAD at discharge and after 3 months (primary outcome); and Short Physical Performance Battery (SPPB), ambulatory capacity, number of falls, re-hospitalisation and death during a 3-month follow-up (secondary outcomes).ResultsMedian duration of hospitalisation was 7 days (interquartile range 4 days). Compared with admission, the intervention group had a lower risk of HAD at discharge (odds ratio [OR]: 0.32; 95% confidence interval [CI]: 0.11–0.92) and at 3-months follow-up (OR 0.24; 95% CI: 0.08–0.74) than controls during follow-up. No intervention effect was noted for the other secondary endpoints (all p>0.05), although a trend towards a lower mortality risk was observed in the intervention group (p=0.078).Conclusion and implicationsThese findings demonstrate that a simple inpatient exercise programme significantly decreases the risk of HAD in acutely hospitalised, very old patients.Trial registrationNCT0137489 (https://clinicaltrials.gov/ct2/show/NCT01374893).Brief summaryA simple inpatient intervention consisting of walking and rising from a chair (∼20 minutes/day) considerably decreases the risk of hospitalisation-associated disability in acutely hospitalised older patients.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
R Alves Pinto ◽  
T Proenca ◽  
M Martins Carvalho ◽  
S Torres ◽  
C X Resende ◽  
...  

Abstract Introduction Elderly people represents a vulnerable and increasing population presenting with acute coronary syndrome (ACS). Several data suggest the benefit of an early revascularization in ST-elevation (STE)-ACS or non-STE-ACS with positive troponin. However questions persist considering the unavoidable adverse prognosis, patient's functional and cognitive status, comorbidities and preferences. Purpose To evaluate a group of very old patients who underwent emergent coronary angiography (CA). Methods We retrospectively analyzed a group of very old patients (≥90 year-old) who underwent emergent CA from January 2008 to September 2020. Clinical features were collected; survival and MACE were compared with an aged-matched control population with ACS not submitted to emergent CA. MACE was defined as a composite of all-cause death, ischemic stroke, ACS or hospitalization for acute heart failure. Results A total of 34 patients were enrolled: 56% female, with mean age 92±2 year-old. As for the cardiovascular risk factors, 88% had hypertension, 49% dyslipidaemia, 12% diabetes and 15% were previous smokers. Concerning other comorbidities, 27% had atrial fibrillation, 21% chronic kidney disease, 12% had cerebrovascular disease and median modified Rankin scale for neurologic disability was 2. Almost all patients had STE-ACS, 68% anterior and 29% inferior, inferolateral or inferoposterior infarction; 3% had infarction of indeterminate location. In CA, 65% had multivessel disease, 14% of them involving left main coronary artery; coronary intervention was performed in 71% of patients (mostly stent implantation), the remaining 29% had no invasive treatment. Concerning to clinical status, median troponin was 131 517 ng/L and median BNP 496 pg/mL; 36% of patients evolved in Killip class III or IV and only 32% of patients had normal left ventricular systolic function. Regarding mortality, 38% of patients died in the index-event versus 25% in the aged-matched control group (p=0.319). During five years of follow-up, there was no significant difference in mortality between the two groups (Log Rank, p=0.403) and more than 50% of patients died in two years. Comparing MACE occurrence, both groups were similar (Log Rank, p=0,662), with more than 80% having at least one event in five years. Conclusion Very old patients submitted to emergent CA had a high percentage of multivessel disease, left ventricular dysfunction and mortality during hospitalization. Compared to an aged-matched control group, they showed no survival or MACE benefit of emergent CA strategy during a five-years follow-up. Although this is a small study, these findings highlight the efforts that should be made to optimize care in this vulnerable population, under-represented in the clinical trials. Special caution should be given to avoid possible unnecessary discomfort in this setting. FUNDunding Acknowledgement Type of funding sources: None. MACE analysis


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 251-251
Author(s):  
Diana M Greenfield ◽  
Nina Salooja ◽  
Christophe Peczynski ◽  
Steffie van der Werf ◽  
Helene Schoemans ◽  
...  

Abstract Metabolic syndrome (MetS) is defined as a clustering of five factors including (1) fasting hyperglycaemia (2) hypertriglyceridaemia (3) low HDL cholesterol (4) hypertension (5) obesity (high waist circumference). According to the International Diabetes Federation harmonised definition, a large waist circumference plus any other two features meet criteria for diagnosis of MetS. It is associated with raised risk of cardiovascular disease (CVD) by 3-fold and is increasingly recognised in patients after HCT. Recent guidelines for long-term HCT survivors recommend screening for MetS. We performed a large cross-sectional service evaluation of HCT survivors in centres working in accordance with international screening guidelines. We have previously presented interim results regarding the prevalence of MetS and associated risk factors and now present the final results. This was an EBMT approved cross-sectional, non-interventional study of consecutive HCT patients (allo and auto) aged 18+ years and a minimum of 2 year post-transplant attending routine follow-up HCT and/or late effects clinics in 9 centres. Centres completed proformas incorporating routine recording of the MetS parameters (given above) as well as performance status (ECOG); evidence of cardiovascular events; family history of premature CVD; and relevant drug history. Univariate comparison of patients and HCT characteristics between the 2 groups (MetS vs no MetS) was performed using non-parametric Mann-Witney U test for continuous variables and Chi-square test or Fisher test for categorical variables. All tests were two-sided. Multivariate logistic regression analyses were performed to predict MetS and cardiovascular events. Variables with a p-value <0.2 in univariate analysis were included. Table 1 gives the population demographic, age, primary disease and transplant details. The prevalence of MetS was 30.4% (allo 29%, auto 35.6% ns). There was a significant difference in prevalence by age at follow-up (p<0.001 with increasing age) with 39% having MetS in those aged 50+. ECOG status was not significantly different between those with or without MetS. No relationship between presence or degree of acute or chronic GvHD was observed and no difference in current use of immunosuppressant therapy. Notably, there was a significantly higher prevalence of cardiovascular events in those with MetS than those without (22.6.vs 10.7%, P=0.006). Logistic regression analysis confirmed that MetS is a predictor of cardiovascular events (OR 4.72, 95%CI 2.11-10.57). CVE were also associated with occurrence of a second malignancy (OR 7.93, 95%CI 2.91-21.61). There was an influence of increasing age both in the prevalence of metabolic syndrome (OR 7.3, 95% CI 3.2,16.8) and CVE (OR 3, 95%CI 0.8-11.32) for the over 50s compared with those aged 18-29. This large study in HCT survivors confirms high prevalence of metabolic syndrome following both allogeneic and autologous HCT of 30.4% overall rising to 39% in those aged over 50 years at follow-up. The data support MetS being an age-related late effect of HCT that is strongly associated with not only cardiovascular events but also the occurrence of second cancers. Further analysis examining the relationship between intensity of treatment and prevalence of MetS and CVE is needed. The data supports routine screening for MetS of both allo and auto HCT patients. Early intervention of reversible features of MetS with lifestyle and medical management may reduce the risk of cardiovascular events, but this needs be tested in a randomised controlled trial setting. Meanwhile, screening and management should be robustly integrated within routine HCT long-term follow-up care. Table 1. Table 1. Disclosures Cortelezzi: janssen: Consultancy; novartis: Consultancy; roche: Consultancy; abbvie: Consultancy. Mohty:Jazz Pharmaceuticals: Honoraria, Research Funding, Speakers Bureau; Servier: Consultancy; Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; MaaT Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Speakers Bureau; Bristol Myers: Consultancy, Research Funding; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Molmed: Consultancy; Janssen: Honoraria, Research Funding, Speakers Bureau. Kroeger:Novartis: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Riemser: Honoraria, Research Funding; JAZZ: Honoraria; Sanofi: Honoraria; Neovii: Honoraria, Research Funding. Snowden:Jazz & Sanofi: Other: Speaker fees at ASH; Jannssen/J&J: Other: Speaker fees.


Medicina ◽  
2021 ◽  
Vol 57 (10) ◽  
pp. 1017
Author(s):  
Federica Bertoli ◽  
Bruno Bais ◽  
Daniele De Silvestri ◽  
Barbara Mariotti ◽  
Daniele Veritti ◽  
...  

Background and objectives: Because few data are available, the aim of this study is to analyze the effects of antithrombotic agents (ATAs) on visual function and long-term risk of cardiovascular events and mortality in hypertensive patients with retinal vein occlusion (RVO). Materials and methods: Hypertensive patients with RVO were consecutively selected from 2008 to 2012 and followed for a median of 8.7 years. Ophthalmologists evaluated and treated RVO complications, and best-corrected visual acuity (BCVA) was checked at each visit during the first one year of follow-up. Survival analysis was conducted on the rate of the composite endpoint of all-cause deaths or non-fatal cardiovascular events. Results: Retrospectively, we collected data from 80 patients (age 68 ± 12 years, 39 males). Central and branch RVO was present in 41 and 39 patients, respectively, and 56 patients started ATAs (50 antiplatelet drugs, 6 warfarin, and 2 low-molecular weight heparin). Average BCVA of the cohort did not change significantly during one-year of follow-up. The only predictor of BCVA was the baseline BCVA value. There was a reduction in proportion and severity of macular edema and an increase in the cumulative proportion of retinal vein patency reestablishment during the follow-up, independent of treatment. ATAs had no effects on one-year BCVA, intraocular complications, or the composite endpoint rate. Conclusions: In this exploratory study, ATAs had no effect on BCVA during the first one year of follow-up and on the composite endpoint during the long-term follow-up. Further prospective studies need to be conducted with an accurate standardization of the intraocular and antithrombotic treatment to define the positive or negative role of ATAs in hypertensive patients with RVO.


Sign in / Sign up

Export Citation Format

Share Document