-
The Annals of Pharmacotherapy Aug 2021To evaluate clinical literature for direct oral anticoagulants (DOACs) therapy for non-Food and Drug Administration approved indications.
Off-label Use for Direct Oral Anticoagulants: Valvular Atrial Fibrillation, Heart Failure, Left Ventricular Thrombus, Superficial Vein Thrombosis, Pulmonary Hypertension-a Systematic Review.
OBJECTIVE
To evaluate clinical literature for direct oral anticoagulants (DOACs) therapy for non-Food and Drug Administration approved indications.
DATA SOURCES
Articles from MEDLINE, Cochrane Library, Google Scholar, and OVID databases were reviewed from 1946 through September 4, 2020.
STUDY SELECTION AND DATA EXTRACTION
Fully published studies assessing DOACs for atrial fibrillation (AF) with valvular heart disease (VHD), heart failure (HF), left ventricular thrombus (LVT), superficial vein thrombosis (SVT), or pulmonary hypertension (PH) were evaluated.
DATA SYNTHESIS
Our review showed that DOACs are safe to use in patients with AF and VHD except for mitral stenosis or mechanical heart valve. Rivaroxaban 2.5 mg twice daily should be used with caution in patients with HF with reduced ejection fraction until further evaluation is performed. Four retrospective studies for DOAC use in patients with LVT showed conflicting results. One phase 3 randomized controlled trial showed noninferiority of rivaroxaban to fondaparinux for SVT treatment. The use of DOACs for pulmonary arterial hypertension was not evaluated in any clinical study, but 2 retrospective studies for the use of DOACs in patients with chronic thromboembolic PH (CTEPH) showed similar efficacy between DOACs and warfarin.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
This review provides clinicians with a comprehensive literature review surrounding DOAC use in common off-label indications.
CONCLUSION
DOACs can be considered for AF complicated by VHD except for mitral stenosis or mechanical valve replacement. DOACs (especially rivaroxaban) are considered as an alternative therapy for SVT and CTEPH. Further prospective studies for DOAC uses are needed for HF or LVT.
Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Heart Failure; Humans; Hypertension, Pulmonary; Off-Label Use; Prospective Studies; Retrospective Studies; Stroke; Thrombosis
PubMed: 33148014
DOI: 10.1177/1060028020970618 -
Systematic Reviews Oct 2020Dextro-transposition of the great arteries (D-TGA) is the most frequent cyanotic congenital heart pathology in neonates. Surgical correction of this condition is... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dextro-transposition of the great arteries (D-TGA) is the most frequent cyanotic congenital heart pathology in neonates. Surgical correction of this condition is possible using the arterial switch operation (ASO) which was first performed by Jatene in 1975.
OBJECTIVES
The aim of this study was to summarise the evidence on short- (less than 1 year), medium- (1-20 years), and long-term (more than 20 years) outcomes of children with D-TGA treated with the ASO. The primary outcome was survival. Secondary outcomes were freedom from cardiac reoperations, occurrence of aortic insufficiency, pulmonary stenosis, coronary artery anomalies, neuropsychological development problems and quality of life.
METHODS
We searched MEDLINE, EMBASE, CINAHL, LILACS, and reference lists of included articles for studies reporting outcomes after ASO for D-TGA. Screening, data extraction and risk of bias assessment were done independently by two reviewers. We pooled data using a random-effects meta-analysis of proportions and, where not possible, outcomes were synthesized narratively. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the certainty of the evidence for each outcome.
MAIN RESULTS
Following ASO for TGA, short-term survival was 92.0% (95% CI 91.0-93.0%; I = 85.8%, 151 studies, 30,186 participants; moderate certainty evidence). Medium-term survival was 90.0% (95% CI 89.0-91.0%; I = 84.3%, 133 studies; 23,686 participants, moderate certainty evidence), while long-term survival was 87.0% (95% CI 80.0-92.0 %; I = 84.5%, 4 studies, 933 participants, very low certainty evidence). Evaluation of the different secondary outcomes also showed satisfactory results in the short, medium and long term. Subgroup analysis suggests slightly higher survival following ASO for TGA in the second surgical era (1998 to 2018) than in the first surgical era (1975 to 1997) in the short and medium term [93.0% (95% CI 92.0-94.0) vs 90.0% (95% CI 89.0-92.0) and 93.0% (95% CI 91.0-94.0) vs 88.0% (87.0-90.0%) respectively] but not in the long term [81.0% (95% CI 76.0-86.0%) vs 89.0% (80.0-95.0%)].
CONCLUSIONS
Pooled data from many sources suggests that the ASO for D-TGA leads to high rates of survival in the short, medium, and long term.
Topics: Arterial Switch Operation; Arteries; Child; Humans; Infant, Newborn; Quality of Life; Reoperation; Transposition of Great Vessels; Treatment Outcome
PubMed: 33028389
DOI: 10.1186/s13643-020-01487-3