Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II.
OBJECTIVE
In mechanical heart valve recipients, low-dose international normalized ratio (INR) self-management of oral anticoagulants can reduce the risk of developing thrombo-embolic events and improve long-term survival compared with INR control by a general practitioner. Here, we present data on the safety of low-dose INR self-management.


RESULTS
In a prospective, randomized multi-centre trial, 1346 patients with a target INR range of 2.5-4.5 and 1327 patients with a target INR range of 1.8-2.8 for aortic valve recipients and an INR range of 2.5-3.5 for mitral or double valve recipients were followed up for 24 months. The incidence of thrombo-embolic events that required hospital admission was 0.37 and 0.19% per patient year in the conventional and low-dose groups, respectively (P = 0.79). No thrombo-embolic events occurred in the subgroups of patients with mitral or double valve replacement. The incidence of bleeding events that required hospital admission was 1.52 and 1.42%, respectively (P = 0.69). In the majority of patients with bleeding events, INR values were < 3.0. Mortality rate did not differ between the study groups.


CONCLUSIONS
Data demonstrate that low-dose INR self-management does not increase the risk of thrombo-embolic events compared with conventional dose INR self-management. Even in patients with low INR target range, the risk of bleeding events is still higher than the risk of thrombo-embolism.
Koertke
Heinrich
H
Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia Bad Oeynhausen, University Hospital of the Ruhr-University of Bochum, Georgstr.11 32545, Bad Oeynhausen, Germany. hkoertke@hdz-nrw.de
Zittermann
Armin
A
Tenderich
Gero
G
Wagner
Otto
O
El-Arousy
Mahmoud
M
Krian
Arno
A
Ennker
Juergen
J
Taborski
Uwe
U
Klövekorn
Wolf Peter
WP
Moosdorf
Rainer
R
Saggau
Werner
W
Koerfer
Reiner
R
D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D001021:Aortic Valve / Q000601:surgery; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012648:Self Care; D013223:Statistics as Topic; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control*
D000925:Anticoagulants