Intensity of oral anticoagulation after implantation of St. Jude Medical mitral or multiple valve replacement: lessons learned from GELIA (GELIA 5)
a Department of Cardiothoracic and Vascular Surgery, Johannes Gutenberg-University, Mainz, Germany
b Heart Center North Rhine-Westphalia, Department of Cardiology, Bad Oeynhausen, Germany
c Institute for Medical Outcome Research (IMOR), Loerrach, Germany
* Correspondence: Diethard Pruefer, MD, Department of Cardiothoracic and Vascular Surgery, Johannes Gutenberg-University, Langenbeck-Str. 1, D-55131, Mainz, Germany.
Abstract
Aims The purpose of the present analysis was to determine survival rate, and risk for thromboembolic and bleeding complications after mechanical heart valve replacement with St. Jude Medical mechanical heart (bileaflet) valves under differing regimens of postoperative anticoagulation.
Method In the randomized German Experience with Low Intensity Anticoagulation (GELIA) study, 553 patients after mitral valve replacement and 158 patients after double valve replacement with a St. Jude Medical prosthesis were randomly assigned to three groups for postoperative oral anticoagulation: group A, target International Normalized Ratio (INR) range 3·0–4·5; group B, target INR range 2·5–4·0; and group C, target INR range 2·0–3·5.
Results The various anticoagulation regimens had no significant impact on risk for bleeding or thromboembolism, or cumulative survival rate after mitral valve replacement. However, less intensive anticoagulation (target INR range 2·0–3·5) was associated with a significant decrease in cumulative survival rate after combined valve replacement, although analysis confirmed that 54% of these deaths were not valve related.
Conclusion The results suggest that in terms of low-intensity anticoagulation an INR of 2·0–3·5 after mitral valve replacement and of 2·5–4·0 after double valve replacement (aortic and mitral) may be recommended when using the St. Jude Medical bileaflet prosthetic valve.
Key Words: Anticoagulant regimen • bleeding • heart valve prosthesis • survival rate • thromboembolism
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