The optimal therapeutic range for oral anticoagulant treatment as suggested by fibrinopeptide A (FpA) levels in patients with heart valve prostheses

1989 ◽  
Vol 19 (2) ◽  
pp. 181-184 ◽  
Author(s):  
V. PENGO ◽  
P. PERUZZI ◽  
M. BACA ◽  
A. MARZARI ◽  
F. ZANON ◽  
...  
1997 ◽  
Vol 77 (05) ◽  
pp. 0839-0844 ◽  
Author(s):  
Vittorio Pengo ◽  
Fabio Barbero ◽  
Alberto Banzato ◽  
Elisabetta Garelli ◽  
Franco Noventa ◽  
...  

SummaryBackground. The long-term administration of oral anticoagulants to patients with mechanical heart valve prostheses is generally accepted. However, the appropriate intensity of oral anticoagulant treatment in these patients is still controversial.Methods and Results. From March 1991 to March 1994, patients referred to the Padova Thrombosis Center who had undergone mechanical heart valve substitution at least 6 months earlier were randomly assigned to receive oral anticoagulants at moderate intensity (target INR = 3) or moderate-high intensity (target INR = 4). Principal end points were major bleeding, thromboembolism and vascular death. Minor bleeding was a secondary end-point.A total of 104 patients were assigned to the target 3 group and 101 to the target 4 group; they were followed for from 1.5 years to up 4.5 years (mean, 3 years). Principal end-points occurred in 13 patients in the target 3 group (4 per 100 patient-years) and in 20 patients in the target 4 group (6.9 per 100 patient-years). Major hemorrhagic events occurred in 15 patients, 4 in the target 3 group (1.2 per 100 patient-years) and 11 in the target 4 group (3.8 per 100 patient-years) (p = 0.019). The 12 recorded episodes of thromboembolism, 4 of which consisted of a visual deficit, were all transient ischemic attacks, 6 in the target 3 group (1.8 per 100 patient-years) and 6 in the target 4 group (2.1 per 100 patient- years). There were 3 vascular deaths in each group (0.9 and 1 per 100 patient-years for target 3 and target 4 groups, respectively). Minor bleeding episodes occurred 85 times (26 per 100 patient-years) in the target 3 group and 123 times (43 per 100 patient-years) in the target 4 group (p = 0.001).Conclusions. Mechanical heart valve patients on anticoagulant treatment who had been operated on at least 6 months earlier experienced fewer bleeding complications when maintained on a moderate intensity regimen (target INR = 3) than those on a moderate-high intensity regimen (target INR = 4). The number of thromboembolic events and vascular deaths did not differ between the two groups.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1878-1878
Author(s):  
Alaa A. Muslimani ◽  
Timothy P. Spiro ◽  
Asif A. Chaudhry ◽  
Hamed A. Daw

Abstract Introduction: Patients (pts) with solid tumors and venous thromboembolic episodes (VTE) have a high risk of complications (recurrent VTE/bleeding) during oral anticoagulant treatment. However, few data are available in pts with lymphoma. We conducted a retrospective study to determine the frequency of complications during oral anticoagulant treatment in lymphoma pts. Methods: Charts of histologically proven non-Hodgkin’s (NHL) and Hodgkin lymphoma (HL) pts at our institution from January 1998 through April 2007 were retrospectively reviewed. After excluding pts with thrombocytosis, solid tumors, hypercoagulability or previous treatment with anticoagulants, pts with their first acute symptomatic VTE were identified (49 NHL, 8 HL). 31 were males and 26 females, with an age range of 40–89 years. The first symptomatic VTE was defined as lymphoma associated if the VTE occurred within 3 months before or after the biopsy diagnosis of the lymphoma but before chemotherapy. These VTE were confirmed by contrast venography or doppler ultrasound for venous thrombosis (neck and upper-lower extremities) and chest computed tomography, ventilation/perfusion scan, or pulmonary angiography for pulmonary embolism. Major bleeding was defined as bleeding that required transfusion, caused a drop of hemoglobin > 2 g/dL, or occurred in critical sites. Minor bleeding was defined as any overt bleeding that required stopping the anticoagulant treatment but not fulfilling the definition of major bleeding. Results: All 57 pts were initially treated with high dose adjusted intravenous heparin or body weight adjusted low molecular weight heparin (LMWH). 46 pts were started on oral warfarin during the first 10 days of the initial treatment witch was continued for at least 3 months after discontinuing heparin. 11 pts received continuing LMWH and no warfarin. Recurrent VTE occurred in 14/46 pts on warfarin therapy. The international normalized ratio (INR) was within the therapeutic range (2.0–3.0) in 10/14 pts, and below the therapeutic INR (< 2.0) in 4/14 pts. Death was directly correlated to recurrent VTE (massive pulmonary embolism) in 2 pts in the warfarin treated group; a third death was caused by massive intracranial bleeding. Major bleeding was documented in 6/46 pts (4 pts had an INR within the therapeutic range, 2 had INR > 3), and minor bleeding in 9/46 pts. Recurrent VTE occurred in 1/11 pts treated with LMWH, major bleeding in 0/11 and minor bleeding in 3/11 pts with no deaths. Conclusions: Previous studies showed an overall incidence of 27.1% recurrent thrombosis and 5.4% major bleeding in pts with malignancy treated with oral anticoagulant for VTE. Our study showed 30.4% recurrent thrombosis and 13% major bleeding in pts with lymphoma. Most bleeding and thrombotic complications occurred with an INR within the therapeutic range (65%). The percentage of serious complications was very high during the use of warfarin (43.5%), and the death rate 6.5%, compared to 9% and 0% during the use of LMWH. A high failure rate of oral anticoagulant treatment in pts with lymphoma suggests the need for alternative treatment. Since the number of pts in this retrospective study is small, a prospective randomized, controlled study comparing warfarin with LMWH is indicated.


1981 ◽  
Author(s):  
R M Bertina ◽  
E A Loeliger

The evaluation of the usefullness of chromogenic assays in the control of oral anticoagulant treatment, often is hampered by the rather poor correlation between the new parameter and the reference one (Prothrombin Time determination) within the therapeutical range. This means that before large scale double blind prospective studies can be started, it should be checked that the use of the experimental method will not result in unacceptable deviations in prescribed dosage.From 150 patients (each within therapeutic zone for more than 3 months) blood/plasma was analysed by at least 2 different chromogenic assays (FII, FX) and by the reference method (PT determination); the selection of patients was such to get an equal distribution over the total therapeutic range (2.0-5.0 in terms of proposed International Calibrated Ratio - ICR); on basis of these results a therapeutic range was defined for each of the experimental methods.Next it was checekd to what extent the use of the experimental method would result in differences in prescribed dosages (when compared with the reference method) a. in 100 of the abovementioned patients at subsequent control periods, b. in previously stable patients with a PT < lower limit or > upper limit of the therapeutic zone, and c. in patients starting oral anticoagulant treatment (outclinic patients and hospitalized patients).During the study the precision of the different chromogenic assays was checked using two lyophilized pooled patient plasmas.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4742-4742
Author(s):  
Diana Irina Iosub ◽  
Barone Marisa ◽  
Chiara Beltrametti ◽  
Stefano Barco ◽  
Picchi Chiara ◽  
...  

Abstract Abstract 4742 The MC-SAT program is a telemedicine system developed for the management of patients under oral anticoagulant treatment (OAT). The program constitutes the natural evolution of an original research project, which assessed the capability of a telematic system in managing different chronic patients access flow to health care services. In particular, for patients on oral anticoagulation we planned a direct access to a call center server and a pre-process of the INR data obtained through self-testing with portable prothrombin time (PT) monitor. The original project performed the technology assessment of all the devices and procedures able to automatically drive international normalization ratio (INR) data from patients to specialists in a hospital anticoagulation clinic and to get patients able to read the medical answer. The ability of patients and/or general practitioners to self-determine INR without specific training and the integration of a portable PT monitor for home use into routine patient care in anticoagulation clinics was subsequently successfully evaluated. After a pilot phase of the project, during which the feasibility of the MC-SAT telemedicine service was assessed, we started the enrollment of consecutive patients. Controls matched by age (+/− 5 years), sex and therapeutic range with the cases, were selected among those who attended our anticoagulation clinic (whose population reaches 3,557 individuals) and were managed by usual care. At the beginning of the program, which is still ongoing, a portable monitor (Coagucheck®, Roche Diagnostics, Germany) has been given to 40 patients and to 10 general practitioners (GPs) provided with portable monitors and Internet access. Each GP had the task to follow 5 patients on chronic OAT. Subsequently, additional 40 patients joined, referring to the preferred community laboratory to perform the prothrombin time and subsequently send the INR results through MC-SAT. To date, the system works like this: the INR data, obtained through the portable monitor or through a local laboratory, is sent by GPRS cellular phone or by Internet computer. When an alert output is detected, an automatic message is sent to the specialist. GPRS services are implemented in order to connect the specialist to the database containing the clinical history of the patient. The specialist is able to monitor, from any location, by means of smartphone or tablet PC, all INR values recorded by the system, all the previous patient accesses to the hospital and the last weekly OAT dose. On these basis, if necessary, a change of the weekly OAT doses is made and transferred to the GP's or patients' computer. Since the start of this project in its definitive shape in june 2009, we enrolled 130 patients allocated to prolonged oral anticoagulant treatment. Of these, 80 were directly assisted by our clinic. The remaining 50 patients were assigned to the GPs. Of the 130 patients originally enrolled, 39 never provided any data. These 39 patients were among those assigned to the GPs. Even if periodically urged to do so, GPs sent data on 11 patiens only. Of the 80 patients directly assisted by our clinic, who utilized either the given portable monitor or referred to a community laboratory, 69 showed great interest to the program, did send their results and continue to do so, utilizing the system 1104 times during the period july 2010-june 2011, with a mean of 16 prescription/year/patient. No significant differences were recorded in the TTR (time in therapeutic range) between the patients enrolled and the controls. More than 80% of the answers were given before 9 hours from the request. After two years, we confirm that the use of the system represents an improvement in the management of patients under oral anticoagulant treatment, by favouring communications and, potentially, clinical outcomes. The program showed to work better when it involves the individual patient rather than GPs. Disclosures: No relevant conflicts of interest to declare.


1995 ◽  
Vol 74 (01) ◽  
pp. 506-510 ◽  
Author(s):  
Raul Altman ◽  
Jorge Rouvier ◽  
Enrique Gurfinkel

Circulation ◽  
1995 ◽  
Vol 92 (12) ◽  
pp. 3464-3472 ◽  
Author(s):  
Pieter M. Vandervoort ◽  
Neil L. Greenberg ◽  
Min Pu ◽  
Kimerly A. Powell ◽  
Delos M. Cosgrove ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document