Location
Suwannee, GA
Start Date
10-5-2021 12:00 AM
End Date
13-5-2021 12:00 AM
Description
Background: Direct oral anticoagulants (DOACs) are indicated to treat and prevent venous thromboembolism and to prevent stroke or systemic embolism in patients with non-valvular atrial fibrillation. The introduction of DOACs has provided an alternative to warfarin for patients in need of oral anticoagulation. It is, however, unclear whether DOACs are safe and effective in patients with heart valve replacement. The RE-ALIGN trial published in 2013 did not support the use of dabigatran in patients with mechanical valve replacements; however, there are ongoing studies, such as the PROACT Xa trial and the ATLANTIS trial, investigating the use of other DOACs in patients with heart valve replacements. This study is to evaluate and describe a potential risk of valve thrombosis in patients with heart valve replacement and treated with a DOAC.
Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic literature search was performed on June 24th, 2020 using three electronic databases (Pubmed, Embase, Cochrane Library) with the following key terms: (apixaban OR rivaroxaban OR edoxaban OR dabigatran OR direct oral anticoagulant OR factor Xa inhibitor OR direct thrombin inhibitor OR target specific oral anticoagulant) and (valve replacement OR valve implantation). Duplicates were removed automatically by Endnote and Rayyan QCRI. Two authors independently screened the search result using Rayyan QCRI (a systematic review web app). Different decisions were resolved through consensus between the two authors with the input of the third author. Pooled case reports were assessed and reported using descriptive analysis.
Results: Of the initial 967 citations, 19 case reports involving 22 patients were identified and assessed in this study. 45.5%, 31.8%, and 22.7% of the patients were taking dabigatran, rivaroxaban, and apixaban, respectively. 11 patients (50%) had mechanical valves, and 11 patients (50%) had bioprosthetic valves. The average age of the patients was 65.2 years (SD±14.3) with 54.5% female. 59.1% of the patients had another indication for anticoagulation other than heart valve replacement. Of those patients, 92.3% had atrial fibrillation, and 7.7% had deep vein thrombosis. 13.6% of the cases reported concurrent aspirin use. 3 patients (13.6%) had cancer as a comorbid condition, and 1 patient (4.5%) had a valve-in-valve replacement. 95.5% of the 21 cases reported an intervention with 13 patients (61.9%) receiving surgery (11 valve replacements, 2 thrombectomies) and 8 patients (38.1%) receiving medical management. 4.5% of the cases reported death prior to intervention. The time reported from onset of DOAC therapy to onset of thrombotic event ranged from 9 days to 33 months.
Conclusions: It is still uncertain whether DOACs are safe or effective in preventing valve thrombosis for different types of valve replacements. The use of DOACs in patients with valve replacement should be limited to those with no other alternative. Further research is needed to determine the effectiveness and safety of DOAC use in patients with prior valve replacements.
Embargo Period
6-4-2021
Direct Oral Anticoagulants and Prosthetic Heart Valves: A Systematic Review of Case Reports
Suwannee, GA
Background: Direct oral anticoagulants (DOACs) are indicated to treat and prevent venous thromboembolism and to prevent stroke or systemic embolism in patients with non-valvular atrial fibrillation. The introduction of DOACs has provided an alternative to warfarin for patients in need of oral anticoagulation. It is, however, unclear whether DOACs are safe and effective in patients with heart valve replacement. The RE-ALIGN trial published in 2013 did not support the use of dabigatran in patients with mechanical valve replacements; however, there are ongoing studies, such as the PROACT Xa trial and the ATLANTIS trial, investigating the use of other DOACs in patients with heart valve replacements. This study is to evaluate and describe a potential risk of valve thrombosis in patients with heart valve replacement and treated with a DOAC.
Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic literature search was performed on June 24th, 2020 using three electronic databases (Pubmed, Embase, Cochrane Library) with the following key terms: (apixaban OR rivaroxaban OR edoxaban OR dabigatran OR direct oral anticoagulant OR factor Xa inhibitor OR direct thrombin inhibitor OR target specific oral anticoagulant) and (valve replacement OR valve implantation). Duplicates were removed automatically by Endnote and Rayyan QCRI. Two authors independently screened the search result using Rayyan QCRI (a systematic review web app). Different decisions were resolved through consensus between the two authors with the input of the third author. Pooled case reports were assessed and reported using descriptive analysis.
Results: Of the initial 967 citations, 19 case reports involving 22 patients were identified and assessed in this study. 45.5%, 31.8%, and 22.7% of the patients were taking dabigatran, rivaroxaban, and apixaban, respectively. 11 patients (50%) had mechanical valves, and 11 patients (50%) had bioprosthetic valves. The average age of the patients was 65.2 years (SD±14.3) with 54.5% female. 59.1% of the patients had another indication for anticoagulation other than heart valve replacement. Of those patients, 92.3% had atrial fibrillation, and 7.7% had deep vein thrombosis. 13.6% of the cases reported concurrent aspirin use. 3 patients (13.6%) had cancer as a comorbid condition, and 1 patient (4.5%) had a valve-in-valve replacement. 95.5% of the 21 cases reported an intervention with 13 patients (61.9%) receiving surgery (11 valve replacements, 2 thrombectomies) and 8 patients (38.1%) receiving medical management. 4.5% of the cases reported death prior to intervention. The time reported from onset of DOAC therapy to onset of thrombotic event ranged from 9 days to 33 months.
Conclusions: It is still uncertain whether DOACs are safe or effective in preventing valve thrombosis for different types of valve replacements. The use of DOACs in patients with valve replacement should be limited to those with no other alternative. Further research is needed to determine the effectiveness and safety of DOAC use in patients with prior valve replacements.