Intensity of oral anticoagulation after implantation of St. Jude Medical aortic prosthesis: analysis of the GELIA Database (GELIA 4)

Abstract

Aims No prospective studies exist that define the ideal target International Normalized Ratio (INR) with respect to anticoagulation-related complications and survival rates after valve replacement with mechanical prostheses. The purpose of the present analysis is to determine optimal levels of anticoagulation for St. Jude Medical mechanical aortic prostheses (St. Jude Medical, Inc., St. Paul, MN, U.S.A.). Method Patients who received a St. Jude Medical mechanical prosthesis were randomized to three ranges of INR for postoperative oral anticoagulation: stratum A, INR 3·0–4·5; stratum B, INR 2·5–4·0; and stratum C, INR 2·0–3·5. This intent-to-treat analysis is based on the assigned range, not the actual range. Results In total, 2024 patients with aortic valves were included in the German Experience with Low Intensity Anticoagulation (GELIA) study, with 672, 677 and 675 patients in strata A, B and C, respectively. The percentages of patients who achieved an INR within their target range in each stratum are as follows: 43·3% in stratum A; 62·8% in stratum B; and 75·9% in stratum C. Patients who self-managed their anticoagulation therapy achieved an INR within their target range more often than did those who were managed by conventional methods. No statistically significant differences in adverse event rates were identified between strata. Conclusion A target INR range of 2·0–3·5 is preferable to the usual 3·0–4·5 range in reducing the number of severe bleeding complications in patients implanted with a St. Jude Medical prosthesis. Self-management of INR may result in better achievement of target INR levels.