The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481: The Home INR Study (THINRS), a randomized, controlled trial.

摘要: Anticoagulation (AC) is effective in reducing thromboembolic events for individuals with atrial fibrillation (AF) or mechanical heart valve (MHV), but maintaining patients target range international normalized ratio (INR) can be difficult. Evidence suggests increasing INR testing frequency improve time (TTR), this impractical in-clinic testing. The objective of study was to test the hypothesis that more frequent patient-self (PST) via home monitoring increases TTR. This planned substudy conducted as part Home Study, a randomized controlled trial every 4 weeks versus PST at three different intervals. setting 6 VA centers across United States. 1,029 candidates AF MHV were trained and tested competency using ProTime meters; 787 deemed competent and, after second consent, four arms: high quality AC management (HQACM) dedicated clinic, venous once weeks; telephone monitored weekly; twice weekly. primary endpoint TTR 1-year follow-up. secondary endpoints were: major bleed, stroke death, life. Results showed increased (59.9 ± 16.7 %, 63.3 14.3 66.8 13.2 % [mean SD] groups underwent weeks, weekly weekly, respectively). proportion poorly managed (i.e., <50 %) significantly lower HQACM, decreased increased. Patients their care providers unblinded given nature HQACM. In conclusion, improved reduced patients.