Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II.

Abstract:

AIMS: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. METHODS AND 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. CONCLUSION: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.

journal_name

Eur Heart J

journal_title

European heart journal

authors

Koertke H,Zittermann A,Tenderich G,Wagner O,El-Arousy M,Krian A,Ennker J,Taborski U,Klövekorn WP,Moosdorf R,Saggau W,Koerfer R

doi

10.1093/eurheartj/ehm391

subject

Has Abstract

pub_date

2007-10-01 00:00:00

pages

2479-84

issue

20

eissn

0195-668X

issn

1522-9645

pii

ehm391

journal_volume

28

pub_type

杂志文章,多中心研究,随机对照试验
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    pub_type: 杂志文章,多中心研究

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    更新日期:1994-02-01 00:00:00

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    doi:10.1093/oxfordjournals.eurheartj.a061382

    authors: Nelson GI,Ahuja RC,Silke B,Okoli RC,Hussain M,Taylor SH

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    doi:10.1093/eurheartj/11.suppl_f.5

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    pub_type: 杂志文章,随机对照试验

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    pub_type: 杂志文章,多中心研究,随机对照试验

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