Self-management of oral anticoagulation reduces major outcomes in the elderly

2008 ◽  
Vol 100 (12) ◽  
pp. 1089-1098 ◽  
Author(s):  
Ivo Rakovac ◽  
Caroline Kleespies ◽  
Brigitte Piso ◽  
Ulrike Didjurgeit ◽  
Andrea Siebenhofer ◽  
...  
Keyword(s):  
Oral Anticoagulation ◽  
The Elderly ◽  
Routine Care ◽  
Self Management ◽  
Bleeding Complications ◽  
Care Group ◽  
Intention To Treat ◽  
Treat Analysis

SummaryAlthough many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N=99) or routine care group (RCG) (N=96).The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 ± 1.2 and 3.0 ± 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p=0.049).

Self-management of oral anticoagulation in the elderly: Rationale, design, baselines and oral anticoagulation control after one year of follow-up

2007 ◽  
Vol 97 (03) ◽  
pp. 408-416 ◽  
Author(s):  
Ivo Rakovac ◽  
Caroline Kleespies ◽  
Brigitte Piso ◽  
Ulrike Didjurgeit ◽  
Andrea Siebenhofer
Keyword(s):  
Elderly Patients ◽  
Oral Anticoagulation ◽  
Controlled Trial ◽  
Training Programme ◽  
Self Management ◽  
Target Range ◽  
Care Group ◽  
Bleeding Events ◽  
Anticoagulation Control

SummarySelf-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N=99) or routine care group (RCG) (N=96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.

Abstract 2752: Pulmonary Vein Isolation With And Without Additional Ablation Of Complex Fractionated Electrograms In Paroxysmal Atrial Fibrillation: Long-term Results Of A Prospective Randomized Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Isabel Deisenhofer ◽  
Tilko Reents ◽  
Heidi L Estner ◽  
Stephanie Fichtner ◽  
Christian von Bary ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Paroxysmal Atrial Fibrillation ◽  
Randomized Study ◽  
Intention To Treat ◽  
Long Term Follow Up ◽  
Treat Analysis

Introduction: Segmental pulmonary vein isolation (PVI) leads to elimination of paroxysmal atrial fibrillation (AF) in approximately 75% of patients. Ablation of complex fractionated atrial electrograms (CFAE) is an alternative ablation strategy. In this prospective randomized study the long-term effect of PVI alone is compared to the effect of combined PVI and CFAE ablation in paroxysmal AF. Methods: 98 patients with paroxysmal AF (57±10 years, 74 male) were randomly assigned to PVI (48 patients) or PVI+CFAE ablation (50 patients). Additional CFAE ablation was performed in the PVI+CFAE group if AF was still inducible after PVI. Follow-up results were assessed with repetitive 7 days Holter ECG and clinical evaluation including repeat ablations. Results: Additional CFAE ablation was performed in 30/50 (60%) patients of the PVI+CFAE group with still inducible AF after PVI. In each group, 2 patients were lost to long term follow-up. In the intention-to-treat analysis at 3 months and after 19±8 months, there was no significant difference between both groups (36/48 [75%] and 34/46 [74%] patients in the PVI and 37/50 [73%] and 40/48 [83%] of patients in the PVI+CFAE ablation group in sinus rhythm [p=0.32]). In subgroup analysis, patients actually treated with the combined PVI+CFAE ablation approach had a significantly better long-term success (25/28; 89%) than patients with still inducible AF who underwent PVI only (22/30;73%; p=0.02). In both groups repeat ablations were performed in 31% (PVI group; 15/48 patients) and 35% (PVI+CFAE group; 17/48 patients) (p=n.s). After 9 months, significantly more patients in the PVI+CFAE group experienced sustained regular atrial tachycardia than in the PVI group (6/44 versus 1/39 patients, P=0.02). Conclusion: The combination of PVI and CFAE ablation was equally effective than PVI alone in reaching freedom of AF in the intention-to-treat analysis. During long-term follow-up, patients actually treated with combined PVI+CFAE ablation had a significantly better outcome (89% vs. 73%). However, the rate of ablation-induced regular atrial tachycardias is inreased.

Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation (allo-SCT) for Patients with Acute Myeloid Leukemia (AML): Long Term Results of a “Donor” Versus “No Donor” Comparison.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1090-1090
Author(s):  
Mohamad Mohty ◽  
Hugues de Lavallade ◽  
Jean El-Cheikh ◽  
Patrick Ladaique ◽  
Catherine Faucher ◽  
...  
Keyword(s):  
Long Term Results ◽  
Donor Group ◽  
No Donor ◽  
Actual Performance ◽  
Intention To Treat ◽  
Related Donor ◽  
The Difference ◽  
Treat Analysis

Abstract RIC regimens have emerged as an attractive modality to decrease transplant-related toxicity (TRM). However, the potential higher relapse rate after RIC allo-SCT is still under considerable debate. This report describes the long term results of 95 consecutive AML patients, diagnosed between Nov. 1999 and Dec. 2003 in a single institution, and who were considered as potential candidates for RIC-allo-SCT. Using a genetic randomization through a “donor” versus “no donor” comparison, the aim was to assess the real benefit of RIC-allo-SCT for adult AML and its impact on outcome. In this series, 35 patients (37%; “donor” group) had an “identified” HLA-identical sibling donor, while the remaining 60 patients had no HLA-matched related donor (“no donor” group). As per institutional policy, HLA-matched unrelated donors were not considered during the study period. No significant differences in patients or AML features were found between the two groups. In the “donor” group, 25 patients (71%; median age, 51 (range, 26–60)) could actually proceed to the RIC-allo-SCT. The 10 remaining patients with an identified donor did not receive allo-SCT because of early relapse after CR (n=2), patient or donor refusal (n=6), and psychiatric disorders appearing before allo-SCT (n=2). The current median follow-up is 60 months. In an “intention-to-treat” analysis, the KM estimate of leukemia-free survival (LFS) was significantly higher in the “donor” group as compared to the “no donor” group (P=0.003; 60% versus 23% at 7 years). When restricting the analysis to patients who could actually receive the RIC-allo-SCT (median follow-up, 40 months from time of allo-SCT), the difference in LFS was also significant between this group of 25 patients (“transplant” group) and the remaining 70 patients (“no transplant” group) who did not receive allo-SCT (P=0.0002; 72% versus 24% at 7 years). In the “transplant” group, RIC-allo-SCT was performed at a median of 209 (range, 119–413) days after diagnosis. No major toxicities were encountered during RIC administration (fludarabine, busulfan and ATG), and only 3 patients died from TRM, for a cumulative incidence of 12% (95%CI, 3–32%) at last follow-up. This relatively low TRM translated towards a significantly higher overall survival (OS) in the “transplant” group as compared to the “no transplant” group (P=0.0003). In the “intention-to-treat” analysis, OS was still significantly higher in the “donor” group as compared to the “no donor” group (P=0.003; Figure below). After controlling for relevant factors, in the multivariate analysis, only actual performance of RIC-allo-SCT (P=0.0005; RR=4.1; 95%CI, 1.8–9.1), was significantly predictive of an improved LFS, further confirming the overall benefit of RIC-allo-SCT for adult AML patients. We conclude that if a matched related donor is identified, RIC-allo-SCT should be proposed since it represents a valid and potentially curative option for AML patients not eligible for standard myeloablative allo-SCT. Figure Figure

Systematic review of studies of self-management of oral anticoagulation

2004 ◽  
Vol 91 (02) ◽  
pp. 225-232 ◽  
Author(s):  
Andrea Berghold ◽  
Peter Sawicki ◽  
Andrea Siebenhofer
Keyword(s):  
Quality Of Life ◽  
Statistical Analysis ◽  
Oral Anticoagulation ◽  
Routine Care ◽  
Self Management ◽  
Bleeding Complications ◽  
Related Quality ◽  
Anticoagulation Control ◽  
Randomised Controlled

SummaryThis work is aimed at assessing the evidence for the possible improvement of therapeutic control of anticoagulation, reduction of major bleedings, thromboembolism and improvement of treatment-related quality of life in patients with self-managed oral anticoagulation therapy versus oral anticoagulation patients on routine care. Randomised controlled trials (RCTs) were identified using the COCHRANE LIBRARY, MEDLINE and EMBASE from 1966 to 2003. RCTs were selected involving patients with oral anticoagulation, which were designed to compare a self-management group to a routine care group. Abstracts and keywords were screened and, in the case of potential inclusion, evaluated. We identified nine potentially relevant trials. Five were excluded for the following reasons: double publication, the patients involved performed only selftesting, or the results of the trial were only published as an abstract. Ultimately, four randomised controlled studies fulfilled the criteria for inclusion. Anticoagulation control: Statistical analysis was not possible because of the great variety of international normalised ratio measurements per patient between the different studies. Comparing the four studies, there was no difference in oral anticoagulation control between self-management care and management by a specialised anticoagulation clinic. In comparison with routine care by general practitioners, self-management care was found to be better. Major bleeding, arterial and venous thromboembolism: Data were available for all studies; however, the studies were either underpowered or obviously not valid and therefore not suitable for statistical analysis. Treatment-related quality of life: Data were available for two studies, which showed that self-management could clearly improve treatment-related quality of life. Patients’ self-management can improve the quality of oral anticoagulation as an indirect parameter of a reduced risk for thromboembolic and bleeding complications. Self-management oral anticoagulation treatment is safe and improves treatment-related quality of life. Patients’ self-management is safe and can improve the quality of anticoagulation control, however, no valid long term study has yet actually demonstrated reduction of bleeding and thromboembolic events.

scholarly journals DOP07 Long-term results of 4.5 years of faecal microbiota transplantation for treatment of refractory ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S045-S045
Author(s):  
A Uygun ◽  
M F Karakaya ◽  
H Erdal ◽  
G Celebi ◽  
Y S Sakin ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Protocol Analysis ◽  
Long Term Results ◽  
Faecal Microbiota ◽  
Intention To Treat ◽  
Tnf Α ◽  
Treat Analysis

Abstract Background Faecal microbiota transplantation (FMT) provides replacement of pathogenic bacteria with more favourable microbiomes in recipients with dysbiosis. The aim of the present study was to prospectively investigate the efficacy of FMT by assessing the clinical and endoscopic response in patients with ulcerative colitis (UC) who had failed anti-inflammatory, immunosuppressive and TNF-α inhibitors (Infliximab, Adalimumab, Vedolizumab) therapy. Methods In this prospective and uncontrolled study, 116 patients with UC were enrolled. All medications except mesalazine were discontinued 1 week before FMT. Colonoscopy was performed both before and after FMT. To assess the efficacy of FMT, Mayo scores were calculated at weeks 0, 24 and 48. A total of 400–600 ml of extracted fresh faecal suspension was administered into the 20 to 30  cm of terminal ileum of recipients. Results After 4.5 years of FMT experience with 116 patients, who have completed their 6 months after 236 procedures of FMT for treatment of UC, 42 of the 116 patients showed full clinical response (100% clinical + laboratory + endoscopically full response) (per-protocol analysis 37.1%), (intention-to-treat analysis 36.2%) at Week 48 and 33 of the 116 patients achieved clinical and endoscopic remission (laboratory 70%, clinically and endoscopically 50–75% improvement) (per-protocol analysis 29.2%), (intention-to-treat analysis 28.4%) at Week 48. Thirty-eight of the 116 patients were accepted as nonresponders at the end of Week 48 (per-protocol analysis 29.2%), (intention-to-treat analysis 32.7%) and 3 patients (2.5%) were lost to follow-up. There was no significant difference among donors concerning both the rate of clinical remission and clinical response. At 4.5 years, serious side effects were observed on 2 patients, 1 colon perforation and 1 toxic megacolon; both were directed to surgery. In 48 weeks’ follow-up, 31 patients (26.7%) experienced mild adverse events after FMT, such as elevated white blood cell counts and ESR, nausea, abdominal pain and high fever, all were managed conservatively. Conclusion FMT could be considered as a promising rescue treatment modality before surgery in patients with refractory UC. Our research is the first in the world for the treatment of UC resistant to medical treatment before surgery. Also, it is the first research to show the long-term results of FMT. FMT appears to be significantly safer and more tolerable than the immunosuppressive and TNF-α inhibitors therapy in patients with UC.

Effect of Related and Unrelated Donor Haemopoietic Stem-Cell Transplantation on Outcome In Adults with High Risk Acute Leukemia: An Intention-to-Treat Analysis at a Single Center Institution

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2385-2385
Author(s):  
Maria Teresa Lupo-Stanghellini ◽  
Magda Marcatti ◽  
Milena Coppola ◽  
Barbara Forno ◽  
Cinzia Bitetti ◽  
...  
Keyword(s):  
High Risk ◽  
Outcome Analysis ◽  
Intention To Treat ◽  
Haemopoietic Stem Cell ◽  
The Status ◽  
Haemopoietic Stem Cell Transplantation ◽  
Treat Analysis ◽  
Donor Source

Abstract Abstract 2385 Background. Allogeneic haemopoietic stem cell transplantation (HSCT) is the best therapeutic option for high-risk hematological disease (HRHD), particularly acute myeloid and lymphoblastic leukemia (AML/ALL). A widely application of HSCT is limited by lack of availability of a suitable donor for every candidate patients (pts). In order to offer a donor to every candidate pts, several centers had developed in the last decade alternative strategy of HSCT, such as umbilical cord blood (UCB) or family haploidentical HSCT (haplo-HSCT). With the aim to treat high-risk leukemia in the ideal appropriate time by allogeneic HSCT, we adopted a policy relying upon HLA typing at entry of every pts diagnosed with HRHD, followed, in absence of a MRD, by the prompt activation of the MUD search. Patients lacking a MRD or a MUD at the appropriate timing are proposed for haplo-HSCT. Methods. Here we report an intention-to-treat analysis of alternative donor HSCT at our Institution for pts diagnosed with high risk AML or ALL. Data were obtained from local institutional database. Results. Between Jan-2004 and July-2010 241 pts (median age 48y, r 15–72) with diagnosis of ALL (60 pts; median age 33y, r 15–64; male 39) or AML (181 pts, median age 51y, r 19–72; male 83) were defined as “high risk status” and received an indication to HSCT according to EBMT (European Group for Blood and Marrow Transplantation) and Northern Italy Leukemia Group (NILG, www.nilg.it) recommendations. In the ALL group 3 pts died before proceed to HSCT, 5 pts are waiting for the identification of a donor. Overall, 52/60 (86%) pts underwent HSCT, the status of disease at transplant was of complete remission (CR) for 27 pts, persistence of disease (PD) for 25. In the AML group 6 pts died before proceed to HSCT, 15 pts are waiting for the identification of a donor. Overall, 160/181 (88%) pts underwent HSCT, the status of disease at transplant was of CR for 97 pts, PD 63. Overall 92 pts activated the research of a MUD, 42 proceed to transplant, 7 received a UCB, 26 received a haplo-HSCT due to absence of a suitable donor in the appropriate time frame or failure to met the criteria to engage a MUD donor. The median time from diagnosis to registry activation was 69 days (r 5–876), the median time from activation to transplant 84 days (r 28–348). In the group of pts in CR at transplant, 37 underwent HSCT from a MRD and 36 from a MUD, 4 pts received a UCB and 47 a haplo-HSCT. Seventy-two pts are alive and in CR at last follow-up, 3/72 after a second transplant from a different donor (haplo-HSCT) and 3/72 after chemotherapy and adoptive immunotherapy to treat hematological relapse. Fifty-two pts died and the causes of death were: relapse (27), infection-related (19), graft-versus-host-disease (GvHD; 5), acute myocardial infarction (1). In the group of pts in PD at transplant, 16 underwent HSCT from a MRD and 6 from a MUD, 3 pts received UCB and 63 a haplo-HSCT. Fifteen pts are alive, 14 in CR, 1 pts under adoptive immunotherapy; 1/14 pts received a second transplant from a different donor (haplo-HSCT) to treat hematological relapse. Seventy-three pts died and the causes of death were: relapse (43), infection (23), GvHD (7). Overall, the median survival is 382 days and the median follow-up for pts alive is 548 days. The 1-year overall survival (OS)/transplant related mortality (TRM)/relapse incidence (RI) are 50,76% 26,96% and 40% respectively. For pts transplanted in CR the 1y OS/TRM/RI are 77,2%, 20,01% and 25% respectively. The outcome analysis per donor source (MRD vs MUD vs haplo-HSCT) is comparable (p=ns). For pts transplanted in PD the 1y OS/TRM/RI are 19,7%, 41% and 67% respectively. The outcome analysis per donor source (MRD vs MUD vs haplo-HSCT) shows a trend of lower RI and TRM in the haplo-SCT vs MRD. Conclusion. The policy adopted provided an allogeneic HSCT in > 80% of candidate high-risk acute leukemia patients. No significant differences were registered in outcome for patients transplanted from matched-related, unrelated or family haploidentical donors. Further evaluation and a long-term follow-up will add important evaluation in term of long-term disease control and long-term toxicities. Disclosures: Bonini: MolMed: Consultancy. Bordignon: Molmed: Employment.

scholarly journals ‘New Medicine Service’: supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial

2019 ◽  
Vol 29 (4) ◽  
pp. 286-295 ◽  
Author(s):  
Rachel Ann Elliott ◽  
Matthew J Boyd ◽  
Lukasz Tanajewski ◽  
Nick Barber ◽  
Georgios Gkountouras ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Link Type ◽  
Medicine Service ◽  
Randomised Controlled ◽  
Treat Analysis ◽  
New Medicine Service

ObjectiveTo examine the effectiveness and cost-effectiveness of the community pharmacy New Medicine Service (NMS) at 26 weeks.MethodsPragmatic patient-level parallel randomised controlled trial in 46 English community pharmacies. 504 participants aged ≥14, identified in the pharmacy when presenting a prescription for a new medicine for predefined long-term conditions, randomised to receive NMS (n=251) or normal practice (n=253) (NMS intervention: 2 consultations 1 and 2 weeks after prescription presentation). Adherence assessed through patient self-report at 26-week follow-up. Intention-to-treat analysis employed. National Health Service (NHS) costs calculated. Disease-specific Markov models estimating impact of non-adherence combined with clinical trial data to calculate costs per extra quality-adjusted life-year (QALY; NHS England perspective).ResultsUnadjusted analysis: of 327 patients still taking the initial medicine, 97/170 (57.1%) and 103/157 (65.6%) (p=0.113) patients were adherent in normal practice and NMS arms, respectively. Adjusted intention-to-treat analysis: adherence OR 1.50 (95% CI 0.93 to 2.44, p=0.095), in favour of NMS. There was a non-significant reduction in 26-week NHS costs for NMS: −£104 (95% CI −£37 to £257, p=0.168) per patient. NMS generated a mean of 0.04 (95% CI −0.01 to 0.13) more QALYs per patient, with mean reduction in lifetime cost of −£113.9 (−1159.4, 683.7). The incremental cost-effectiveness ratio was −£2758/QALY (2.5% and 97.5%: −38 739.5, 34 024.2. NMS has an 89% probability of cost-effectiveness at a willingness to pay of £20 000 per QALY.ConclusionsAt 26-week follow-up, NMS was unable to demonstrate a statistically significant increase in adherence or reduction in NHS costs, which may be attributable to patient attrition from the study. Long-term economic evaluation suggested NMS may deliver better patient outcomes and reduced overall healthcare costs than normal practice, but uncertainty around this finding is high.Trial registration numberNCT01635361, ISRCTN23560818, ISRCTN23560818, UKCRN12494.

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