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The Annals of Pharmacotherapy Feb 2024The SAMe-TTR score identifies patients on vitamin K antagonists (VKAs) who are more likely to have poor time in therapeutic range (TTR); however, the association between... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The SAMe-TTR score identifies patients on vitamin K antagonists (VKAs) who are more likely to have poor time in therapeutic range (TTR); however, the association between SAMe-TTR and clinical outcomes remains controversial.
OBJECTIVES
The objective is to assess the association of SAMe-TTR score with clinical outcomes and poor TTR in patients on VKAs.
METHODS
We searched using the term "SAMe-TTR." Original articles reporting clinical outcomes and SAMe-TTR scores before October 2021 were included. Odds ratios (ORs) of clinical outcomes, diagnostic accuracy parameters of poor TTR (<60%-70%), and mean TTR were extracted. Meta-analysis was performed using random-effects models.
RESULTS
Ten studies were included (N = 22 894); 4 showed pooled changes in TTR of -3.61% (95% CI:-4.88% to -2.35%) and -3.98% (95% CI: -6.08% to -1.87%) at SAMe-TTR scores ≥2 and ≥3, respectively, compared with lower scores. The diagnostic accuracy parameters for poor TTR were too heterogeneous to conclude. SAMe-TTR ≥3 significantly correlated with all adverse events (OR = 1.43 [95% CI: 1.29-1.54; < 0.001]), composite thromboembolism (OR = 1.53 [95% CI: 1.19-1.97; = 0.001]), and composite bleeding (OR = 1.33 [95% CI: 1.12-1.59; = 0.001] regardless of the indication, while an SAMe-TTR ≥2 significantly correlated with mortality (OR = 1.32 [95% CI: 1.02-1.70; = 0.033]). We found no relationship between an SAMe-TTR ≥3 and mortality or between a score ≥2 and clinical outcomes.
CONCLUSIONS AND RELEVANCE
Patients on VKAs with SAMe-TTR ≥3 experienced more adverse events, bleeding, and thromboembolism compared with patients who had an SAMe-TTR <3. However, the score had limited and inconclusive predictability for poor TTR in the study.
Topics: Humans; Atrial Fibrillation; International Normalized Ratio; Anticoagulants; Hemorrhage; Thromboembolism; Vitamin K; Fibrinolytic Agents; Stroke
PubMed: 37125752
DOI: 10.1177/10600280231166643 -
American Journal of Cardiovascular... May 2023Atrial fibrillation (AF) frequently complicates hypertrophic cardiomyopathy (HCM), and anticoagulation significantly decreases the risk of stroke in this population. To... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Atrial fibrillation (AF) frequently complicates hypertrophic cardiomyopathy (HCM), and anticoagulation significantly decreases the risk of stroke in this population. To date, no randomized controlled trials (RCTs) have compared direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs). The present study aimed to systematically compare the two anticoagulation strategies in terms of effectiveness and safety.
METHOD
We performed a systematic literature search and meta-analysis in the PubMed, MEDLINE, and EMBASE databases for studies reporting all-cause mortality, major bleeding, or thromboembolic events (TEs). Since no RCTs were available, we included observational studies only. The overall hazard ratio (HR) and 95% confidence interval (CI) for each analyzed parameter were pooled using a random-effects model.
RESULTS
Five observational studies including 6919 patients were eligible for inclusion. Compared with VKAs, DOACs were associated with statistically significant lower rates of all-cause mortality (HR 0.64, 95% CI 0.35-0.54; p < 0.00001), comparable major bleeding events (HR 0.64, 95% CI 0.40-1.03; p = 0.07), and TEs (HR 0.94, 95% CI 0.73-1.22; p = 0.65).
CONCLUSIONS
Compared with VKAs, a DOAC-based strategy might represent an effective and safe strategy regarding all-cause mortality, major/life-threatening bleeding complications, and TEs in HCM patients with concomitant AF. However, further prospective studies are necessary to reinforce a DOAC-based anticoagulation strategy in this population.
Topics: Humans; Atrial Fibrillation; Anticoagulants; Hemorrhage; Stroke; Thromboembolism; Cardiomyopathy, Hypertrophic; Administration, Oral; Vitamin K
PubMed: 37061614
DOI: 10.1007/s40256-023-00580-x -
JPMA. the Journal of the Pakistan... Nov 2022This systematic review and meta-analysis aims to estimate the prevalence of neonatal vitamin K prophylaxis refusal among parents and its possible association with... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aims to estimate the prevalence of neonatal vitamin K prophylaxis refusal among parents and its possible association with subsequent vaccine hesitancy or refusal.
METHODS
The databases searched included PubMed, Cochrane Library, Embase via Ovid, CINAHL Plus and Medline via EBSCOhost, ProQuest and PsycINFO from inception to 31 August 2017. Keywords, such as "vitamin K", "refusal", "decline", "hesitancy", and "vaccination" were used to identify potential studies. Analysis of proportions was conducted, while odd ratios and relative risks were estimated using the random effect model.
RESULTS
Of the 2216 studies identified, 8(0.36%) were subjected to qualitative analysis; 4(50%) retrospective cohort studies and 4(50%) cross-sectional studies. Overall, 6(75%) studies were of good quality, while 2(25%) were ranked as of fair quality. Of the 273,714 parents, 3,136(1.14%) refused to opt for the vitamin K prophylaxis. Meta-analysis concluded that refusal to vitamin K prophylaxis was significant among the included studies ((p<0.184).
CONCLUSIONS
The overall risk of refusal to essential vaccination among vitamin K prophylaxis refusal group was 6.45 times compared to the group that accepted vitamin K prophylaxis.
Topics: Infant, Newborn; Humans; Vitamin K; Retrospective Studies; Cross-Sectional Studies; Treatment Refusal; Vaccination Refusal; Parents; Vitamins; Dietary Supplements
PubMed: 37013297
DOI: 10.47391/JPMA.3914 -
European Journal of Cardio-thoracic... Apr 2023We conducted a systematic review and meta-analysis of randomized controlled trials comparing direct oral anticoagulants (DOACs) to vitamin K antagonists (VKAs) in the... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
We conducted a systematic review and meta-analysis of randomized controlled trials comparing direct oral anticoagulants (DOACs) to vitamin K antagonists (VKAs) in the first 90 days after bioprosthetic valve implantation.
METHODS
We systematically searched Embase, Medline and CENTRAL. We screened titles, abstracts and full texts, extracted data and assessed the risk of bias in duplicate. We pooled data using the Mantel-Haenzel method and random effects modelling. We conducted subgroup analyses based on the type of valve (transcatheter versus surgical) and timing of initiation of anticoagulation (<7 vs >7 days after valve implantation). We assessed the certainty of evidence using the Grading of Recommendations, Assessments, Development and Evaluation approach.
RESULTS
We included 4 studies of 2284 patients with a median follow-up of 12 months. Two studies examined transcatheter valves (1877/2284 = 83%) and 2 examined surgical valves (407/2284 = 17%). We found no statistically significant differences between DOACs and VKAs with regard to thrombosis, bleeding, death or subclinical valve thrombosis. However, there was a subgroup trend towards more bleeding with DOACs when initiated within 7 days of valve implantation.
CONCLUSIONS
In the existing randomized literature on DOACs versus VKAs in the first 90 days after bioprosthetic valve implantation, there appears to be no difference with regard to thrombosis, bleeding or death. Interpretation of the data is limited by small numbers of events and wide confidence intervals. Future studies should focus on surgical valves and should include long-term follow-up to assess any potential impact of randomized therapy on valve durability.
Topics: Humans; Anticoagulants; Hemorrhage; Thrombosis; Fibrinolytic Agents; Vitamin K; Administration, Oral
PubMed: 36971601
DOI: 10.1093/ejcts/ezad110 -
International Journal of Cardiology May 2023A systematic evaluation focused on efficacy and safety for electrical cardioversion of atrial fibrillation (AF) among different Direct Oral Anticoagulants (DOACs) has... (Meta-Analysis)
Meta-Analysis
Safety and efficacy of direct oral anticoagulants versus vitamin K antagonists in atrial fibrillation electrical cardioversion: An update systematic review and meta-analysis.
BACKGROUND
A systematic evaluation focused on efficacy and safety for electrical cardioversion of atrial fibrillation (AF) among different Direct Oral Anticoagulants (DOACs) has not been previously performed. In this setting, we conducted a meta-analysis of studies evaluating DOACs vs vitamin K antagonists (VKA) as common comparator.
METHODS
We searched Cochrane Library, Pubmed, Web Of Science and Scopus databases for all English-only articles concerning studies that have estimated the effect of DOACs and VKA on stroke, transient ischemic attack or systemic embolism (SSE) and major bleeding (MB) events in AF patients undergoing electrical cardioversion. We selected 22 articles comprising 66 cohorts and 24,322 procedures (12,612 with VKA).
RESULTS
During follow-up (studies' median 42 days), 135 SSE (52 DOACs and 83 VKA) and 165 MB (60 DOACs and 105 VKA) were recorded. The overall pooled effects, DOACs vs VKA, was estimated by an univariate Odds Ratio of 0.92 (0.63-1.33; p = 0.645) for SSE and 0.58 (0.41-0.82; p = 0.002) for MB; at bivariate evaluation, adjusting for study type, were respectively 0.94 (0.55-1.63; p = 0.834) and 0.63 (0.43-0.92, p = 0.016). Each single DOAC showed similar and non statistically different results in outcome occurrence compared to VKA as well as when Apixaban, Dabigatran, Edoxaban and Rivaroxaban were indirectly compared to each other.
CONCLUSIONS
In patients undergoing electrical cardioversion, compared to VKA, DOACs have similar thromboembolic protection with lower major bleeding incidence. Single molecule does not show difference in event rate compared to each other. Our findings, provide useful information about safety and efficacy profile of DOACs and VKA.
Topics: Humans; Atrial Fibrillation; Electric Countershock; Anticoagulants; Hemorrhage; Stroke; Embolism; Fibrinolytic Agents; Vitamin K; Administration, Oral
PubMed: 36907451
DOI: 10.1016/j.ijcard.2023.03.023 -
Kardiologiia Feb 2023Aim To perform a systematic review and meta-analysis of efficacy and safety of direct oral anticoagulants (DOAC) as compared to vitamin K antagonists (VKA) in the... (Meta-Analysis)
Meta-Analysis
Aim To perform a systematic review and meta-analysis of efficacy and safety of direct oral anticoagulants (DOAC) as compared to vitamin K antagonists (VKA) in the treatment of left ventricular (LV) thrombosis.Material and methods A search was performed in PubMed and Google Scholar for studies that compared DOAC and VKA in the treatment of LV thrombosis with respect of thromboembolic events, hemorrhagic complications, and thrombus resolution. The effect was evaluated with the odds ratio (OR) that was computed using a fixed effects model.Results For these systematic review and meta-analysis, 19 studies were selected, including 2 randomized and 17 cohort studies. The articles included into these systematic review and meta-analysis, were published from 2018 through 2021. In total, 2970 patients (mean age, 58.8 лет; 1879 (61.2 %) men) with LV thrombus were included into the meta-analysis. Mean follow-up duration was 17.9 months. The meta-analysis showed no significant difference between DOAC and VKA in the incidence of the study outcomes: thromboembolic events (OR, 0.86; 95 % CI: 0.67-1.10; р=0.22), hemorrhagic complications (OR, 0.77; 95 % CI: 0.55-1.07; р=0.12), thrombus resolution (OR, 0.96; 95 % CI: 0.76-1.22; р=0.77). In a subgroup analysis, rivaroxaban compared to VKA significantly (79%) reduced the risk of thromboembolic complications (OR, 0.21; 95 % CI: 0.05-0.83; р=0.03) with no significant differences in hemorrhagic events (OR, 0.60; 95 % CI: 0.21-1.71; р=0.34) or thrombus resolution (OR, 1.44; 95 % CI: 0.83-1.31; р=0.20). The apixaban treatment group had significantly more (4.88 times) cases of thrombus resolution than the VKA treatment group (OR, 4.88; 95 % CI: 1.37-17.30; р=0.01); for apixaban, data on hemorrhagic and thromboembolic complications were not available.Conclusions The therapeutic efficacy and side effects of the DOAC treatment for LV thrombosis were similar to those of VKA with respect of thromboembolic events, hemorrhage, and thrombus resolution.
Topics: Male; Humans; Middle Aged; Female; Thrombosis; Thromboembolism; Heart Diseases; Anticoagulants; Fibrinolytic Agents; Vitamin K
PubMed: 36880139
DOI: 10.18087/cardio.2023.2.n2200 -
Revista Espanola de Cardiologia... Sep 2023Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with... (Meta-Analysis)
Meta-Analysis
INTRODUCTION AND OBJECTIVES
Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature.
METHODS
A systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed.
RESULTS
We included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P=.0068; I=8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P=.29; I=45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P=.054; I=48.7%).
CONCLUSIONS
DOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.
Topics: Humans; Atrial Fibrillation; Anticoagulants; Hemorrhage; Stroke; Embolism; Administration, Oral; Vitamin K
PubMed: 36804556
DOI: 10.1016/j.rec.2023.02.002 -
European Journal of Clinical... Apr 2023The efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) for the treatment of patients with left-sided bioprosthetic heart... (Meta-Analysis)
Meta-Analysis Review
The efficacy and safety of direct oral anticoagulants versus vitamin K antagonists in patients with left-sided bioprosthetic heart valves and atrial fibrillation: a systematic review and meta-analysis.
BACKGROUND
The efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) for the treatment of patients with left-sided bioprosthetic heart valves (BHV) and atrial fibrillation (AF) remain controversial. This study aims to perform a meta-analysis to evaluate the efficacy and safety of DOACs versus VKAs in this region.
METHODS
We retrieved all relevant randomized controlled studies and observational cohort studies, which critically assessed the efficacy and safety of DOACs versus VKAs among patients with left-sided BHV and AF in databases of PubMed, Cochrane, ISI Web of Sciences, and Embase. The efficacy outcomes of this meta-analysis were stroke events and all-cause death when the safety outcomes included major and any bleeding.
RESULTS
The analysis integrated 13 studies while enrolling 27,793 patients with AF and left-sided BHV. DOACs reduced the rate of stroke by 33% compared with VKAs (risk ratio [RR] 0.67; 95% CI 0.50-0.91), with no increased incidence of all-cause death (RR 0.96; 95% CI 0.82-1.12). For safety outcomes, major bleeding was reduced by 28% using DOACs rather than VKAs (RR 0.72; 95% CI 0.52-0.99), while there was no difference in the events of any bleeding (RR 0.84; 95% CI 0.68-1.03). In addition, in patients younger than 75 years old, the stroke rate was reduced by 45% in the population using DOACs (RR 0.55; 95% CI 0.37-0.84).
CONCLUSION
Our meta-analysis demonstrated that in patients with AF and BHV, compared with VKAs, using DOACs was associated with reduced stroke and major bleeding events without an increase of all-cause mortality and any bleeding. In the population younger than 75 years old, DOAC might be more effective in preventing cardiogenic stroke.
Topics: Humans; Aged; Atrial Fibrillation; Anticoagulants; Hemorrhage; Stroke; Vitamin K; Heart Valves; Administration, Oral
PubMed: 36795127
DOI: 10.1007/s00228-023-03463-x -
Internal and Emergency Medicine Mar 2023To compare the efficacy/effectiveness and safety of DOACs versus VKAs in patients with a previously and newly surgically implanted BHV with or without AF. A systematic... (Meta-Analysis)
Meta-Analysis
To compare the efficacy/effectiveness and safety of DOACs versus VKAs in patients with a previously and newly surgically implanted BHV with or without AF. A systematic search on MEDLINE and EMBASE was performed till November 2022. Treatment effects were estimated with relative risk (RR) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed with the I statistic. Four randomized controlled trials (RCTs), 2 subgroup analysis from ARISTOTLE and ENGAGE-AF-TIMI 48 and 4 observational studies were included for a total of 5808 patients, 1893 on DOACs and 3915 on VKAs. AF prevalence was 98.28%. In the overall analysis, DOACs vs VKAs were associated with a RR for stroke/transient ischemic attack (TIA)/systemic embolism (SE) of 0.63 (95% CI 0.51-0.79; I = 0%) and a RR of major bleeding of 0.50 (95% CI 0.39-0.63; I = 0%) in a median follow-up of 19 months (IQR 4.5-33.4). In the 3 RCTs (DAWA, RIVER, ENAVLE), DOACs vs VKAs were associated with a RR of stroke/TIA/SE and major bleeding of 0.38 (95% CI 0.13-1.58, I = 0%) and of 0.68 (95% CI 0.32-1.44; I = 5%) respectively. In patients randomized during the first three months from valve surgery, DOACs vs VKAs were associated with a RR of stroke/TIA/SE and major bleeding of 0.54 (95% CI 0.14-2.08; I = 0%) and of 0.76 (95% CI 0.05-10.72; I = 66%). In previously implanted BHV patients with AF, DOACs showed a risk-benefit profile at least comparable to VKAs. DOACs showed a similar, even if underpowered, risk-benefit profile during the first three months after BHV implantation prevalently in patients with AF.
Topics: Humans; Ischemic Attack, Transient; Atrial Fibrillation; Anticoagulants; Hemorrhage; Stroke; Embolism; Heart Valves; Administration, Oral; Vitamin K; Randomized Controlled Trials as Topic
PubMed: 36746889
DOI: 10.1007/s11739-023-03208-9 -
Expert Review of Hematology Feb 2023Thromboembolic events in myeloproliferative neoplasms (MPNs) are one of the most important causes of mortality and morbidity, in which vitamin K antagonists (VKAs) have...
INTRODUCTION
Thromboembolic events in myeloproliferative neoplasms (MPNs) are one of the most important causes of mortality and morbidity, in which vitamin K antagonists (VKAs) have been used mostly. Recently, direct oral anticoagulants (DOACs) are used in venous thromboembolism (VTE) and cancer-associated thrombosis (CAT). With the adoption of data from CAT and VTE, the usage of DOACs in MPNs is increasing.
AREAS COVERED
In this paper, we performed a systematic review to the current literature regarding the usage of DOACs in MPNs. Eleven studies involving 944 patients were included. The reasons for initiating DOACs were secondary prophylaxis for thrombosis (arterial or venous) and atrial fibrillation (AF) in 562 and 382 patients, respectively. A total of 84 (8.9%) recurrent thrombotic (arterial or venous) events recorded. Forty-six (8.1%) events occurred in the thrombosis group (arterial or venous) and 38 (9.9%) events occurred in patients with AF.
EXPERT OPINION
Ease of management and patient comfort should be regarded as benefits of DOACs compared to VKAs. However, it would be appropriate to bring an individualized approach until we obtain high-quality data with prospectively designed studies involving more patients and longer follow-up time concerning the use of DOACs in patients with MPNs.
Topics: Humans; Venous Thromboembolism; Anticoagulants; Myeloproliferative Disorders; Thrombosis; Atrial Fibrillation; Neoplasms; Administration, Oral; Vitamin K
PubMed: 36709432
DOI: 10.1080/17474086.2023.2174515