BACKGROUND
Mechanical heart valve replacement (MHVR) is an effective method for the treatment of severe heart valve disease, while the patient who was administered with warfarin therapy after MHVR facing a high risk of bleeding and thrombosis. Therefore, as internet-based warfarin management emerged, whether it reduces the complications and improves patient’s life quality remain unknown.
OBJECTIVE
This study aimed to compare effects of internet-based warfarin management and conventional approach in patients who received MHVR. In order to provide evidence regarding alternative strategies for a long-term anticoagulation.
METHODS
This is a prospective, multicenter, randomized, open-label, controlled clinical trial with a follow-up for 1 year. Patients who need long-term warfarin anticoagulation after MHVR were enrolled, then randomly divided into traditional and internet-based management group. The percentage of time in the therapeutic range (TTR) was used as the primary outcome, and the bleeding, thrombosis and other event as secondary outcome.
RESULTS
A total of 721 patients were enrolled and the baseline is not reach statistical different between the two groups, suggesting the random assignment is successful. As a result, the internet-based group showed a significantly higher TTR (0.53±0.24 vs. 0.46±0.21, P<0.01) and fraction of time in therapeutic range (FTTR, 0.48±0.22 vs. 0.42±0.19, P<0.01), than those in the traditional group. Furthermore, as expected, the anticoagulation complications, including the bleeding and embolic events (6.94% vs. 12.74%, P<0.01) have lower frequency in the internet-based group than in the traditional group. Logistic regression shows that internet-based management increased the TTR by 7% (OR=1.07, 95%CL 1.05-1.09, P<0.01), and reduced the bleeding and embolic risk by 6% (OR=0.94, 95%CL 0.92-0.96, P<0.05). Moreover, low TTR is the risk factor of bleeding and embolic events (OR=0.87, 95%CL 0.83-0.91, P<0.05)
CONCLUSIONS
The internet-based warfarin management is superior than the traditional way by reducing the anticoagulation complications in patients who received long-term warfarin anticoagulation after MHVR.
CLINICALTRIAL
ChiCTR1800016204; http://www.chictr.org.cn/showproj.aspx?proj=27518
INTERNATIONAL REGISTERED REPORT
RR2-10.1136/bmjopen-2019-032949
New internet-based warfarin anticoagulation management approach after mechanical heart valve replacement: a prospective, multicenter, randomized controlled trial (Preprint)
