Koertke H, Zittermann A, Minami K, Tenderich G, Wagner O, El-Arousy M, Krian A, Ennker J, Taborski U, Klövekorn WP, Moosdorf R, Saggau W, Morshuis M, Koerfer J, Seifert D, Koerfer R
Title(s)
Low-dose international normalized ratio self-management: a promising tool to achieve low complication rates after mechanical heart valve replacement
Reference(s)
Ann Thorac Surg 2005;79:1909–14
Disease
Valvular heart disease
Purpose
To determine whether a lower target range for international normalised ratio (INR) values using self-management reduces the incidence of postoperative complications after heart valve replacement
Study design
Randomised, controlled
Follow-up
Aim 2 years
Patients
Aim 3300 patients, aged ≥18 years, undergoing heart valve replacement
Treatment regimen
Postoperative low-dose anticoagulation treatment using self-management to target INR 1.8–2.8 for aortic valve recipients or 2.5–3.5 for mitral or double valve recipients, or conventional anticoagulation treatment using self-management to target INR 2.5–4.5
Results
A planned interim analysis of the first 1818 patients (908 low-dose anticoagulation treatment, 910 conventional treatment) showed that INR values were within the therapeutic range in 76% of patients in the low-dose group and in 75% in the conventional-dose group. The rate of thromboembolic events per patient-year was 0.18% in the low-dose group and 0.40% in the conventional-dose group (p = 0.21). The rate of bleeding complications per patient-year was 0.74% in the low-dose group and 1.20% in the conventional-dose group (p = 0.502). Final results not yet available
