scholarly journals New internet-based warfarin anticoagulation management approach after mechanical heart valve replacement: a prospective, multicenter, randomized controlled trial (Preprint)

10.2196/29529 ◽  
2021 ◽  
Author(s):  
Zhihui Zhu ◽  
Chenyu Li ◽  
Jinglun Shen ◽  
Kaisheng Wu ◽  
Yuehuan Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Valve Replacement ◽  
Heart Valve ◽  
Controlled Trial ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Management Approach ◽  
Anticoagulation Management ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

scholarly journals New internet-based warfarin anticoagulation management approach after mechanical heart valve replacement: a prospective, multicenter, randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Zhihui Zhu ◽  
Chenyu Li ◽  
Jinglun Shen ◽  
Kaisheng Wu ◽  
Yuehuan Li ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Therapeutic Range ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Secondary Outcome ◽  
The Internet ◽  
Traditional Group ◽  
Multicenter Randomized Controlled Trial

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

Long-term anticoagulation self-testing after mechanical heart valve replacement

2007 ◽  
Vol 55 (S 1) ◽  
Author(s):  
H Mair ◽  
B Reichart ◽  
I Kaczmarek ◽  
G Juchem ◽  
P Überfuhr ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Mechanical Heart Valve ◽  
Heart Valve Replacement ◽  
Self Testing
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