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Standardization of oral anticoagulant treatment (OAT) in the Valencian community, Spain
ABSTRACTS OF 12TH INTNAT’L CONGRESS
S182
Vol. 65, SuppI. 1
P358 STANDARDIZATION OF ORAL ANTICOAGULANT TREATMENT (OAT) IN THE VALENCIAN COMMUNITY, SPAlN M.A. Fermiadez, M. Rodriguez Arias, A. Sfinchez, Y. Mira, R. Dosd& Clinical Biopathology Dept. “La Fe” Hospital, Valencia, E An important step in standardization of OAT control was the definition of optimal therapeutic range and the standardization of prothrombin time (PT), but although it has been said and written too much on this time, it is far from being a reality. It is believed that with the introduction of international sensitivity index (ISl) to calculate international normalized ratio (INR) it wilI be possible to reduce interlaboratory variations and to compare the results too. Whit the object of verifying the situation in own Community, an external quality control was set up sending anticoagulated lyophilized plasmas and arranging meetings with the participants periodically. The donors were anticoagulated patients screened for hepatitis B, C and AIDS. Plasmas were obtained by centrifugation, dispensed as aliquots into siliconized glass vials, frozen at 8o’C, lyophilized and then sent to 16 hospitals. Results show a large interlaboratory variation (table 1) as it is expected, but when hospitals with the same method are evaluated separately, the results are optimized (table 11)suggesting that both instruments and thromboplastins (TPL) have a highly significant effect on the PT. It would be desirable either the manufacturer supplys the IS1 of each lot of TPL calculated with the most used instruments and to choose the TPL in function of own work conditions or the Standardizatin Committee of 1STH would name one, two or three specific TPLs to control OAT. Table 1. CV between hospitals plasmas cv %
90/I 18.0
9012 26.8
9013 19.4
9014 10.2
9015 Il.6
9016 19.6
91/l 17.7
9112 11.4
9113 15.2
9114 22.1
Table II. CV between hospitals wit the same work conditions. MLA/rabit TPL ACL/rabit TPL ManuaVbovin TPL
9115 19.8 -
plasma 9013
plasma 9014
plasma 9 I13
13.6% 2.8olo 1.50/o
1.5% 7.9% 1.7%
17.6% 5.9% 2.11
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This work is supported by grants from the Investigation Founds of Health Public.
P359 ANTITHROMBOTIC PREVENTION IN AORTOCORONARY BYPASS Aleksandar Lucic, Ljubica Povazan, Visnja Canak, Predrag FiIipov, Radovan Bukvic, Radmila Lazic, Djina Jurisic, Gorana Mitic and Dusanka Gbradovic Institute of Pathological Physiology and Laboratory Diagnostics, Medical School, University of Novl Sad, Novi Sad, Yugoslavia In the prospective study, during the period of five years, the effects of antithrombotic prevention /oral anticoagulants plus antiplatelet drugs or solely anticoagulants/ on the incidence of rethrombosis, haemorrhagic complications and death have been examined in the group of 61 patients (pts) /55 males and 6 females, age range from 47 to 72 and mean age 62 years/ with aortocoronary bypasses after myocardial infarction/ 38 pts/ or unstable angine pectoris / 23 pts/ . Analyses of the feature of the five years oral anticoagulation revealed that 49.8% of laboratory tests of ef&ts of applied oral anticoagulants were in optimal therapeutic range used in our practice, between 1.81 and 4.2 units of International Normalized Ratio (INR) and 32.9% of controls were in relatively satisfactory range, between 1.80 and 1.37 units of INR. During the prospective follow-up the newly developed thrombotic events occured in four pts /6.5% of examined pts/ while four pts died. Besides the relatively good percentage of laboratory controls of anticoagulation in optimal therapeutic range and 2.9% of overdosed controls, the satisfactory degree in the protection of possible haemorrhagic complications in observed pts has been reached. Bleeding occured in the twenty one /34.4% of examined pts/ but the intensity of bleeding was moderate and the pts were treated only by a temporary break in preventive treatment. The relationship between the intensity of hypofoagulability and occurence of haemorrhagic complications was direct and positive. Nevertheless it was not possible to establish any direct relationship between the existing level of systemic coagulability and the incidence of rethmmbosis or death in examined patients.
S182
Vol. 65, SuppI. 1
P358 STANDARDIZATION OF ORAL ANTICOAGULANT TREATMENT (OAT) IN THE VALENCIAN COMMUNITY, SPAlN M.A. Fermiadez, M. Rodriguez Arias, A. Sfinchez, Y. Mira, R. Dosd& Clinical Biopathology Dept. “La Fe” Hospital, Valencia, E An important step in standardization of OAT control was the definition of optimal therapeutic range and the standardization of prothrombin time (PT), but although it has been said and written too much on this time, it is far from being a reality. It is believed that with the introduction of international sensitivity index (ISl) to calculate international normalized ratio (INR) it wilI be possible to reduce interlaboratory variations and to compare the results too. Whit the object of verifying the situation in own Community, an external quality control was set up sending anticoagulated lyophilized plasmas and arranging meetings with the participants periodically. The donors were anticoagulated patients screened for hepatitis B, C and AIDS. Plasmas were obtained by centrifugation, dispensed as aliquots into siliconized glass vials, frozen at 8o’C, lyophilized and then sent to 16 hospitals. Results show a large interlaboratory variation (table 1) as it is expected, but when hospitals with the same method are evaluated separately, the results are optimized (table 11)suggesting that both instruments and thromboplastins (TPL) have a highly significant effect on the PT. It would be desirable either the manufacturer supplys the IS1 of each lot of TPL calculated with the most used instruments and to choose the TPL in function of own work conditions or the Standardizatin Committee of 1STH would name one, two or three specific TPLs to control OAT. Table 1. CV between hospitals plasmas cv %
90/I 18.0
9012 26.8
9013 19.4
9014 10.2
9015 Il.6
9016 19.6
91/l 17.7
9112 11.4
9113 15.2
9114 22.1
Table II. CV between hospitals wit the same work conditions. MLA/rabit TPL ACL/rabit TPL ManuaVbovin TPL
9115 19.8 -
plasma 9013
plasma 9014
plasma 9 I13
13.6% 2.8olo 1.50/o
1.5% 7.9% 1.7%
17.6% 5.9% 2.11
-.-
This work is supported by grants from the Investigation Founds of Health Public.
P359 ANTITHROMBOTIC PREVENTION IN AORTOCORONARY BYPASS Aleksandar Lucic, Ljubica Povazan, Visnja Canak, Predrag FiIipov, Radovan Bukvic, Radmila Lazic, Djina Jurisic, Gorana Mitic and Dusanka Gbradovic Institute of Pathological Physiology and Laboratory Diagnostics, Medical School, University of Novl Sad, Novi Sad, Yugoslavia In the prospective study, during the period of five years, the effects of antithrombotic prevention /oral anticoagulants plus antiplatelet drugs or solely anticoagulants/ on the incidence of rethrombosis, haemorrhagic complications and death have been examined in the group of 61 patients (pts) /55 males and 6 females, age range from 47 to 72 and mean age 62 years/ with aortocoronary bypasses after myocardial infarction/ 38 pts/ or unstable angine pectoris / 23 pts/ . Analyses of the feature of the five years oral anticoagulation revealed that 49.8% of laboratory tests of ef&ts of applied oral anticoagulants were in optimal therapeutic range used in our practice, between 1.81 and 4.2 units of International Normalized Ratio (INR) and 32.9% of controls were in relatively satisfactory range, between 1.80 and 1.37 units of INR. During the prospective follow-up the newly developed thrombotic events occured in four pts /6.5% of examined pts/ while four pts died. Besides the relatively good percentage of laboratory controls of anticoagulation in optimal therapeutic range and 2.9% of overdosed controls, the satisfactory degree in the protection of possible haemorrhagic complications in observed pts has been reached. Bleeding occured in the twenty one /34.4% of examined pts/ but the intensity of bleeding was moderate and the pts were treated only by a temporary break in preventive treatment. The relationship between the intensity of hypofoagulability and occurence of haemorrhagic complications was direct and positive. Nevertheless it was not possible to establish any direct relationship between the existing level of systemic coagulability and the incidence of rethmmbosis or death in examined patients.