Feasibility and safety of a 12-week INR follow-up protocol over 2 years in an anticoagulation clinic: a single-arm prospective cohort study

The 2012 American College of Chest Physicians’ guidelines recommended a 12-week INR follow-up interval may be appropriate for patients on stable warfarin doses. Limited evidence supports this recommendation. A single-arm, prospective cohort study over 24 months was completed in a Veterans Affairs anticoagulation clinic to determine the long-term feasibility and safety of implementing an extended INR follow-up interval in Veterans on stable doses of warfarin. Participants were required to have a stable warfarin dose for 6 months prior to enrollment. A prespecified protocol was used to titrate, extend, and manage the INR interval up to 12 weeks. Scheduling of extended INR intervals was a primary outcome. Safety outcomes included major and serious bleeding and thromboembolic events. A post-hoc comparison of baseline characteristics between individuals who were scheduled for at least 4 consecutive 12-week INR follow-up intervals and those who were not was completed. Of the 50 participants, 36 (72%) were scheduled for at least one 12-week interval and 15 (30%) were scheduled for 4 consecutive intervals. There were 2 thromboembolic events that occurred in 1 participant. There were 28 major and serious bleeding events in 19 participants; 8 occurred while on the extended INR interval. In the post-hoc analysis, no participants scheduled for 4 consecutive 12-week intervals had heart failure. Based on 2 years of monitoring, a 12-week INR follow-up interval using a detailed protocol with titration of INR interval extension appears feasible for a subset of patients. Patients with heart failure may not be suitable for this intervention.