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Clinical Cardiology Apr 2022Vitamin K antagonists (VKA) such as warfarin or phenprocoumon have been the mainstay of therapy for long-term oral anticoagulant therapy (OAT) in patients with atrial... (Randomized Controlled Trial)
Randomized Controlled Trial
Influence of rivaroxaban compared to vitamin K antagonist treatment upon development of cardiovascular calcification in patients with atrial fibrillation and/or pulmonary embolism.
BACKGROUND
Vitamin K antagonists (VKA) such as warfarin or phenprocoumon have been the mainstay of therapy for long-term oral anticoagulant therapy (OAT) in patients with atrial fibrillation or with pulmonary embolism. Due to interferences with matrix Gla-protein, an important vitamin K-dependent local calcification inhibitor in cardiovascular structures, VKA antagonists stimulate cardiovascular calcification (CVC). In contrast, rivaroxaban, a nonvitamin K-dependent oral anticoagulant (NOAC), should be neutral in terms of CVC. We seek to investigate these potential differences in CVC development between VKA versus NOACs in a randomized controlled trial (RCT).
METHODS
The influence of rivaroxaban compared to vitamin K antagonist treatment upon development of cardiovascular calcification in patients with atrial fibrillation and/or pulmonary embolism trial (NCT02066662) is a multicenter, prospective RCT with a two-arm, open-label study design. The primary endpoint is the progression of coronary and aortic valve calcification (quantified as calcification volume score) as assessed by cardiac computed tomography (CT) at 24 months in patients either treated by rivaroxaban or VKA. A total of 192 patients were randomized in a 1:1 fashion. The main inclusion criteria were the presence of atrial fibrillation and/or pulmonary embolism with the indication for OAT and pre-existent coronary calcification. The development of CVC will be assessed by follow-up CT at 12 and 24 months.
RESULTS
In total 192 patients (median age 70, 72% male) were enrolled over a period of 5 years and followed up for 2 years.
Topics: Administration, Oral; Aged; Anticoagulants; Atrial Fibrillation; Female; Fibrinolytic Agents; Humans; Male; Pulmonary Embolism; Rivaroxaban; Stroke; Vitamin K
PubMed: 35332571
DOI: 10.1002/clc.23819 -
EuroIntervention : Journal of EuroPCR... Apr 2017We aimed to assess the efficacy and safety of vitamin K antagonist (VKA) monotherapy in atrial fibrillation (AF) patients undergoing transcatheter aortic valve...
AIMS
We aimed to assess the efficacy and safety of vitamin K antagonist (VKA) monotherapy in atrial fibrillation (AF) patients undergoing transcatheter aortic valve implantation (TAVI).
METHODS AND RESULTS
In 735 TAVIs since 2008 we identified 167 patients suffering from concomitant AF who received either VKA monotherapy (n=77), VKA plus single antiplatelet therapy (SAPT, n=41) or a triple anticoagulation regimen (n=49). Thromboembolic as well as bleeding complications were analysed for six months after TAVI. Only one minor bleeding and no thromboembolic events occurred after VKA therapy had been initiated post TAVI. Compared to patients being treated with additional either single or dual antiplatelet therapy, the incidence of major/life-threatening bleeding complications was significantly lower in the VKA mono group (0/77 [VKA mono] vs. 3/41 [VKA+SAPT; p=0.04] vs. 4/49 [triple anticoagulation; p=0.02]). Analysis of a combined endpoint of post-procedural death, stroke, embolism and major bleeding revealed a significant superiority of VKA monotherapy compared to VKA plus SAPT or DAPT, respectively (5/77 vs. 9/41 [p=0.02] vs. 14/49 [p=0.002]).
CONCLUSIONS
VKA therapy without additional antiplatelet treatment is effective and safe in AF patients undergoing TAVI.
Topics: Aged; Aged, 80 and over; Anticoagulants; Atrial Fibrillation; Feasibility Studies; Female; Germany; Hemorrhage; Humans; Male; Phenprocoumon; Postoperative Complications; Thromboembolism; Transcatheter Aortic Valve Replacement
PubMed: 28433958
DOI: 10.4244/EIJ-D-15-00259 -
BMC Health Services Research Aug 2019In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K... (Randomized Controlled Trial)
Randomized Controlled Trial
Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices - results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment).
BACKGROUND
In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential through implementation of case management, have not yet been investigated satisfactorily. Based on results of a cluster-randomized controlled trial, we aimed to assess whether OAC quality can be improved, any variations between practices exist and determine practice- and patient-level factors.
METHODS
The PICANT trial (2012-2015) was performed in 52 GP practices in Hesse, Germany. Adult patients with long-term indication for OAC received best practice case management in the intervention group. International normalized ratio (INR) values were recorded from anticoagulation passes. The Rosendaal method was used to calculate Time in Therapeutic Range (TTR) at patient level, and mean pooling to obtain center-specific TTR (cTTR) at practice level. The quality of OAC was assessed by TTR and cTTR. Linear model analyses were used to investigate associations between practice-/ patient-level factors and TTR.
RESULTS
Inclusion of 736 patients (49.6% intervention and 50.4% control patients); 690 (93.8%) received phenprocoumon. Within 24 months, the TTR was 75.1% (SD 17.6) in the intervention versus 74.3% (SD 17.8) in the control group (p = 0.670). The cTTR averaged 75.1% (SD 6.5, range: 60.4 to 86.7%) in the intervention versus 74.3% (SD 7.2, range: 52.7 to 85.7%) in the control group (p = 0.668). At practice level, the TTR was significantly lower in practices with a male physician and certification in quality management. At patient level, the TTR was significantly higher in patients with moderate to high compliance, in men, and in patients that performed self-management. The TTR was significantly lower in patients with certain comorbidities, and who were hospitalized.
CONCLUSIONS
The intervention did not effectively improve OAC quality compared to routine care. Quality of INR control was generally good, but considerable variation existed between GP practices. The variability indicates optimization potential in some practices. The demonstrated association between patient-level factors and TTR highlights the importance of considering patient characteristics that may impede achieving high quality therapeutic outcomes.
TRIAL REGISTRATION
ISRCTN registry, ISRCTN41847489 , registered 27 February 2012.
Topics: Administration, Oral; Adult; Anticoagulants; Female; Fibrinolytic Agents; General Practice; Germany; Humans; International Normalized Ratio; Male; Middle Aged; Primary Health Care; Quality of Health Care; Thrombolytic Therapy; Vitamin K
PubMed: 31370840
DOI: 10.1186/s12913-019-4372-y -
Journal of Cardiology Cases Jun 2022We report a multi-morbid patient with mechanical aortic valve and unstable and sub-therapeutic levels of international normalized ratio (INR), initially in phenprocoumon...
We report a multi-morbid patient with mechanical aortic valve and unstable and sub-therapeutic levels of international normalized ratio (INR), initially in phenprocoumon and later in warfarin therapy. All efforts, including self-testing using Point of Care Testing with telemedicine support to stabilize the patient's INR within the therapeutic range, were unsuccessful. Since INR fluctuations can occur due to poor or varied dietary vitamin K, 180 μg/day vitamin K was added to the patient's warfarin treatment in an attempt to stabilize INR fluctuations. Three weeks later INR was in therapeutic range and remained within range for two consecutive months suggesting beneficial effect of vitamin K. Our updated literature review demonstrates that vitamin K supplementation can improve the stability of INR without improvement of time therapeutic range. < Vitamin K antagonist (VKA) is the only approved anticoagulation therapy in patients with mechanical heart valves. The quality of anticoagulation therapy in some of these patients is challenged. There is insufficient evidence to advise routine vitamin K supplementation to all patients receiving VKA treatment. Supplementation, however, could be considered in patients with persistent INR instability, where no alternative anticoagulation therapy is available.>.
PubMed: 35685257
DOI: 10.1016/j.jccase.2021.12.011 -
Journal of Neuro-oncology May 2021Patients with glioblastoma (GBM) or brain metastases (MET) and atrial fibrillation (AF) might be at an increased risk of intracranial hemorrhage (ICH) due to...
PURPOSE
Patients with glioblastoma (GBM) or brain metastases (MET) and atrial fibrillation (AF) might be at an increased risk of intracranial hemorrhage (ICH) due to anticoagulation (AC). Our aim was to assess this risk.
METHODS
Our institution's database (from 2005 to 2017) was screened for patients with GBM or MET and AF with an indication for AC according to their CHADSVASc stroke risk score (≥ 2). Required follow-up was at least 3 months. AC was either performed with heparins, phenprocoumon or non-Vitamin K antagonist oral anticoagulants. Applying the propensity score approach, patient cohorts (matched according to primary tumor, age, sex) were generated (GBM [or MET] with AF ± AC, GBM [or MET] without AF/AC, no GBM [or MET] but AF on AC). ICH was defined as clinical deterioration caused by new blood on imaging. A log rank test was performed to compare the risk for ICH between the three groups.
RESULTS
In total, 104 patients were identified of which 49 with GBM (37% on AC) and 37 with MET (46% on AC) were successfully matched. Median follow up was 8.6 and 7.2 months, respectively. ICH occurred in 10.2% of GBM + AF and 12.2% GBM-AF, whereas 8% of patients with AF on AC suffered ICH (p = 0.076). 13.5% of patients with MET + AF had ICHs, in the controls it was 16% for MET-AF and 8% for AF on AC (p = 0.11).
CONCLUSION
AC did not seem to influence the incidence of ICH in patients with glioblastoma or brain metastases within follow up of just under 9 months.
Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Brain Neoplasms; Glioblastoma; Humans; Intracranial Hemorrhages; Risk Factors; Stroke
PubMed: 33674992
DOI: 10.1007/s11060-021-03716-8 -
British Journal of Clinical Pharmacology Jun 2015Drug-induced liver injury (DILI) is often responsible for acute liver failure, drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a...
AIM
Drug-induced liver injury (DILI) is often responsible for acute liver failure, drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a case-control study to determine the hepatotoxic risk of a wide range of drugs.
METHODS
The Berlin Case-Control Surveillance Study FAKOS included all 51 Berlin hospitals in a hospital network. Between 2002 and 2011, 198 patients with acute idiopathic hepatitis, 377 inpatient controls and 708 outpatient controls were ascertained. Case patients were thoroughly validated using anamnestic, clinical, laboratory and histological data. Drug exposure was obtained in a face-to-face interview. A possible drug aetiology was assessed in individual patients by applying the updated Council for International Organizations of Medical Sciences (CIOMS) scale. Drug risks were further quantified [odds ratios (OR) with 95% confidence intervals (CI)] in a case-control design with unconditional logistic regression analysis. Drug intake in the last 28 days before index date was considered for the analysis.
RESULTS
The study corroborated hepatotoxic risks for a number of drugs, including phenprocoumon (OR 3.3, 95% CI 1.5, 6.7), amiodarone (OR 5.5, 95% CI 1.3, 21.2), clozapine (OR 34.6, 95% CI 2.8, 824.9) and flupirtine (OR 40.2, 95% CI 5.5, 856.9). Increased risks were also suggested for less commonly reported substances such as angiotensin II receptor blockers, atypical antipsychotics and for biperiden, a drug never before reported to be hepatotoxic.
CONCLUSIONS
Our study identified a large number of drugs as possible causes of hepatotoxicity. The observed risk for seldom reported substances highlights the need for further post-authorization safety studies not exclusively focusing on drugs already labelled as potentially hepatotoxic.
Topics: Adult; Aged; Alanine Transaminase; Aspartate Aminotransferases; Berlin; Bilirubin; Biomarkers; Case-Control Studies; Chemical and Drug Induced Liver Injury; Chi-Square Distribution; Female; Hospitals; Humans; Liver; Liver Failure, Acute; Liver Function Tests; Logistic Models; Male; Middle Aged; Odds Ratio; Risk Assessment; Risk Factors; Time Factors
PubMed: 25444550
DOI: 10.1111/bcp.12565 -
Clinical Cardiology Nov 2017Data are limited on the safety of periprocedural anticoagulation with novel oral anticoagulants (NOACs) in patients undergoing pulmonary vein isolation (PVI) using the... (Comparative Study)
Comparative Study
BACKGROUND
Data are limited on the safety of periprocedural anticoagulation with novel oral anticoagulants (NOACs) in patients undergoing pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB) for the treatment of atrial fibrillation.
HYPOTHESIS
We hypothesized that the incidence of acute periprocedural complications in patients undergoing PVI do not differ between patients treated with VKA compared to NOACs.
METHODS
In 200 consecutive patients (mean age, 64.3 _ 10.6 years; female, n = 83) with symptomatic atrial fibrillation, PVI using the second-generation 28-mm CB was performed. In patients treated with NOACs, the medication was stopped the day of the procedure and continued the evening after the procedure with a reduced dosage. Patients treated with phenprocoumon were continued on uninterrupted phenprocoumon with a target INR of 2 to 3. If INR was <2, bridging with low-molecular-weight heparin was performed.
RESULTS
Forty-seven of 200 patients (23.5%) were treated with a vitamin K antagonist (VKA) and 55 (27.5%) were treated with apixaban, 67 (33.5%) with rivaroxaban, and 31 (15.5%) with dabigatran. Seven (3.5%) major complications occurred in the overall population. Major bleeding complications did not differ significantly between the 2 groups (P = 0.23). One patient taking VKA had a pericardial tamponade at the end of the procedure; 2 patients treated with apixaban developed a groin hematoma requiring surgical intervention. Transient ischemic attack occurred in 1 patient of the apixaban and rivaroxaban group.
CONCLUSIONS
Apixaban, rivaroxaban, and dabigatran, compared with uninterrupted VKA, did not show a higher risk for major bleeding or ischemic complications in patients undergoing PVI using the second-generation CB.
Topics: Administration, Oral; Aged; Antithrombins; Atrial Fibrillation; Cardiac Catheters; Cerebrovascular Disorders; Cryosurgery; Dabigatran; Drug Administration Schedule; Drug Monitoring; Equipment Design; Factor Xa Inhibitors; Female; Heparin, Low-Molecular-Weight; Humans; International Normalized Ratio; Male; Middle Aged; Phenprocoumon; Postoperative Hemorrhage; Pyrazoles; Pyridones; Retrospective Studies; Risk Factors; Rivaroxaban; Time Factors; Treatment Outcome; Vitamin K
PubMed: 28846806
DOI: 10.1002/clc.22782 -
Geriatrics (Basel, Switzerland) Mar 2019Chronic wounds are common in elderly patients, and the majority of them are caused by vascular diseases, such as peripheral arterial occlusive disease (PAD) or chronic...
Chronic wounds are common in elderly patients, and the majority of them are caused by vascular diseases, such as peripheral arterial occlusive disease (PAD) or chronic venous insufficiency. Because of typical signs, these diseases can be usually easily differentiated. However, 10% of chronic wounds are caused by specific rare diseases, such as vasculitis, specific infections, skin cancer, or calciphylaxis. Calciphylaxis is a rare cause of chronic wounds, and it is usually found in patients with end-stage renal disease. In this paper, we describe the case of an 83-year-old woman with a chronic ulcer of the lower leg caused by calciphylaxis.
PubMed: 30889873
DOI: 10.3390/geriatrics4010028 -
Innere Medizin (Heidelberg, Germany) Apr 2024A 73-year-old man with dementia was referred to our clinic with hypernatremia and volume depletion. New-onset neurogenic dysphagia was likely the reason for both. The...
A 73-year-old man with dementia was referred to our clinic with hypernatremia and volume depletion. New-onset neurogenic dysphagia was likely the reason for both. The patient had chronic embolic strokes on the computed tomography (CT) images. Documentation from previous hospitalizations in different hospitals revealed a repeatedly prolonged activated partial thromboplastin time (aPTT); 5 years prior, antiphospholipid antibody syndrome had already been suspected, but the necessary workup was never completed. We diagnosed the patient with primary antiphospholipid antibody syndrome and initiated therapy with vitamin K antagonists (phenprocoumon) and aspirin.
Topics: Male; Humans; Aged; Antiphospholipid Syndrome; Anticoagulants; Phenprocoumon; Fibrinolytic Agents
PubMed: 37728737
DOI: 10.1007/s00108-023-01581-3 -
Journal of Thrombosis and Haemostasis :... Dec 2014Depressive symptoms have detrimental effects on quality of life and mortality. Poor adherence to a treatment regimen is a potential mechanism for the increased risk of... (Observational Study)
Observational Study
BACKGROUND
Depressive symptoms have detrimental effects on quality of life and mortality. Poor adherence to a treatment regimen is a potential mechanism for the increased risk of adverse medical events associated with depression. Regarding oral anticoagulation with vitamin K antagonists, adherence is crucial for the outcome. Little is known about the clinical relevance of current depressiveness for anticoagulation treatment.
OBJECTIVES
To examine the impact of current depressiveness on anticoagulation treatment in regular medical care.
PATIENTS/METHODS
We examined the association between clinically significant depressiveness as assessed by the Patient Health Questionnaire-2 ≥ 2 (PHQ-2 ≥ 2) with the percentage of time in the therapeutic range (TTR), self-rated compliance, several aspects of health literacy, anticoagulation side-effects and treatment satisfaction in a cross-sectional study of 1790 oral anticoagulation outpatients.
RESULTS
Seven hundred and sixteen participants (40.0%) had clinically significant depressive symptoms. Depressed persons reported lower compliance with intake of prescribed medication and regular visits for control of anticoagulation, more unspecific side-effects (e.g. pruritus) and lower satisfaction with the anticoagulation treatment and their doctors' expertise and empathy. Depressed as compared with non-depressed individuals had a lower TTR (-4.67; 95% CI, -8.39 to -0.95). Increasing severity of depressiveness was related with decreasing TTR. However, depressiveness lost its significant impact on TTR after multivariable adjustment (-3.11; 95% CI, -6.88 to 0.66).
CONCLUSIONS
Clinically significant depressiveness was highly prevalent and impaired several aspects of anticoagulation treatment. Depressiveness should be regarded as a clinically significant condition that needs to be addressed in the management of anticoagulation patients.
Topics: Administration, Oral; Aged; Ambulatory Care; Anticoagulants; Cohort Studies; Cross-Sectional Studies; Depression; Female; Humans; International Normalized Ratio; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Patient Satisfaction; Phenprocoumon; Prevalence; Quality of Life; Surveys and Questionnaires; Treatment Outcome
PubMed: 25292317
DOI: 10.1111/jth.12743