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.

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).

scholarly journals Clinical Outcomes of Telemonitoring for Patients on Warfarin after Discharge from Hospital

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Natthaporn Sudas Na Ayutthaya ◽  
Itsarawan Sakunrak ◽  
Teerapon Dhippayom
Keyword(s):  
Usual Care ◽  
Clinical Outcomes ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
International Normalized Ratio ◽  
Target Range ◽  
Care Group ◽  
The Impact

Objective. To evaluate the impact of telephone follow-up service on clinical outcomes in patients on warfarin when discharged from hospital. Methods. This randomized controlled trial was conducted at a general hospital in Thailand. Patients aged ≥20 years who were prescribed warfarin when discharged were eligible to participate in this study. They were randomly allocated, using a computer generated random number, to receive either telephone follow-up intervention or usual care. Participants in the intervention group received telephone follow-up by hospital pharmacists for three months. During each telephone call, pharmacists performed medicine use reviews and addressed any problems identified. Key Findings. A total of 50 patients participated in this study. The proportion of international normalized ratio (INR) values in the target range for the telephone follow-up group (36/79, 45.6%) was higher than that in the usual care group (19/79, 24.1%), p=0.005. The mean time in the therapeutic range (TTR) in the telephone follow-up group was also higher than that in the usual care group (49.8±34.3 versus 28.0±27.5, p=0.017). All patients in the usual care group experienced one or more out-of-range INR values (25/25, 100%) compared to 21 out of 25 (84%) in the telephone follow-up group, p=0.037. There was no difference between the two groups in the incidence of complications or adverse events associated with warfarin. Conclusions. The telephone follow-up service in recently discharged patients helps them achieve and maintain their INR target. This anticoagulant supportive service should be promoted to patients receiving warfarin therapy after discharge. This trial is registered with TCTR20180614006 (Thai Clinical Trials Registry).

The current treatment and predictors of outcome in elderly patients with non-ST-elevation myocardial infarction in an all comers population: the POPular Age registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M.E Gimbel ◽  
D.R.P.P Chan Pin Yin ◽  
R.S Hermanides ◽  
F Kauer ◽  
A.H Tavenier ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Cardiovascular Death ◽  
St Elevation ◽  
One Year

Abstract Background Elderly patients form a large and growing part of the patients presenting with non-ST-elevation myocardial infarction (NSTEMI). Choosing the optimal antithrombotic treatment in these elderly patients is more complicated because they frequently have characteristics indicating both a high ischaemic and high bleeding risk. Purpose We describe the treatment of elderly patients (>75 years) admitted with NSTEMI, present the outcomes (major adverse cardiovascular events (MACE) and bleeding) and aim to find predictors for adverse events. Methods The POPular AGE registry is an investigator initiated, prospective, observational, multicentre study of patients aged 75 years or older presenting with NSTEMI. Patients were recruited between August 1st, 2016 and May 7th, 2018 at 21 sites in the Netherlands. The primary composite endpoint of MACE included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke at one-year follow-up. Results A total of 757 patients were enrolled. During hospital stay 76% underwent coronary angiography, 34% percutaneous coronary intervention and 12% coronary artery bypass grafting (CABG). At discharge 78.6% received aspirin (non-users mostly because of the combination of oral anticoagulant and clopidogrel), 49.7% were treated with clopidogrel, 34.2% with ticagrelor and 29.6% were prescribed oral anticoagulation. Eighty-three percent of patients received dual antiplatelet therapy (DAPT) or dual therapy consisting of oral anticoagulation and at least one antiplatelet agent for a duration of 12 months. At one year, the primary outcome of cardiovascular death, myocardial infarction or stroke occurred in 12.3% of patients and major bleeding (BARC 3 or 5) occurred in 4.8% of the patients. The risk of MACE and major bleeding was highest during the first month and stayed high over time for MACE while the risk for major bleeding levelled off. Independent predictors for MACE were age, renal function, medical history of CABG, stroke and diabetes. The only independent predictor for major bleeding was haemoglobin level on admission. Conclusion In this all-comers registry, most elderly patients (≥75 years) with NSTEMI are treated with DAPT and undergoing coronary angiography the same way as younger NSTEMI patients from the SWEDEHEART registry. Aspirin use was lower as was the use of the more potent P2Y12 inhibitors compared to the SWEDEHEART which is very likely due to the concomitant use of oral anticoagulation in 30% of patients. The fact that ischemic risk stays constant over 1 year of follow-up, while the bleeding risk levels off after one month may suggest the need of dual antiplatelet therapy until at least one year after NSTEMI. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): AstraZeneca

scholarly journals Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001253
Author(s):  
Ovidio De Filippo ◽  
Matteo Bianco ◽  
Matteo Tebaldi ◽  
Mario Iannaccone ◽  
Luca Gaido ◽  
...  
Keyword(s):  
Second Generation ◽  
Controlled Trial ◽  
Drug Eluting Stents ◽  
Major Adverse Cardiovascular Events ◽  
Relative Reduction ◽  
Left Main ◽  
Bleeding Events ◽  
Open Label ◽  
Drug Eluting

BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881

4037Nurse counseling of patients with atrial fibrillation to improve compliance to oral anticoagulation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Chilian-Hof ◽  
S Schnupp ◽  
C Mahnkopf ◽  
J Brachmann ◽  
C Kleinecke
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Oral Anticoagulation ◽  
Vitamin K Antagonists ◽  
Randomised Trial ◽  
Female Gender ◽  
Bleeding Risk ◽  
Telephone Counseling ◽  
Bleeding Events

Abstract Background Atrial fibrillation (AF) is the most frequent arrhythmia with a prevalence of 1%–2% in the general population. Oral anticoagulation (OAC) is state-of-the art for preventions of thromboembolic events, in particular ischemic stroke, in patients with atrial fibrillation. Despite its proven benefit, numerous studies have documented under use of OAC for a variety of reasons. Purpose To establish a program of nurse counseling in patient with atrial fibrillation and treatment with oral anticoagulation. The program is designed to improve patients satisfaction, compliance to OAC, prevention of medication errors, ischemic and bleeding events. Methods Patients with atrial fibrillation and treatment with oral anticoagulation were prospectively identified at the department of cardiology of our clinic. They received a 30 minutes nurse counseling about oral anticoagulation during the hospital stay and another 30 minutes telephone counseling 3 months after inclusion. Furthermore, they received a brochure to inform about atrial fibrillation, oral anticoagulation and methods to improve medication compliance. Demographic characteristics with stroke and bleeding risk (CHA2DS2-VASc and HAS-BLED scores), as well as procedural data were systematically assessed in a predefined standardized way and captured in a dedicated database. Results Between June 2017 and January 2018, a total of 617 patients (female gender: 43.1%) with atrial fibrillation and oral anticoagulation received nurse counseling. Demographic and follow-up data of 204 patients (female gender: 85/204 (41.7%); mean age 69.7±17.3, CHA2DS2-VASc score 4.2±1.7, HAS-BLED score 2.8±0.37) were assessed in a dedicated database. Indication for OAC was paroxysmal and persistent/permanent AF in 110/204 (53.9%), 93/204 (45.6%) and others 17 (8.3%), respectively. 33/2014 (16.2%) were treated with vitamin K antagonists, and 172/204 (84.3%) with non-vitamin K antagonists. After a follow-up of 0.46±2.9 years and 187 patients-years the rates of cardiovascular death, major bleeding events and all-cause stroke and TIA were 1.07%, 2.14% and 1.61% per 100 patient-years. Conclusion Nurse counseling in patients with atrial fibrillation and treatment with oral anticoagulation has been established at the REGIOMED clinics, Germany. Its effectiveness in terms of quality of live, medication complications and cardiovascular events has to be proven in a randomised trial. Acknowledgement/Funding Daichi-Sankyo

scholarly journals A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pablo Rodríguez-Sánchez-Laulhé ◽  
Luis Gabriel Luque-Romero ◽  
Jesús Blanquero ◽  
Alejandro Suero-Pineda ◽  
Ángela Biscarri-Carbonero ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Self Management ◽  
Pinch Strength ◽  
Smartphone App ◽  
Therapeutic Exercise ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. Methods The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up. Discussion This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient’s status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care. Trial registration ClinicalTrials.gov NCT04263974. Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

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