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Effectiveness and Safety of DOACs vs. VKAs in AF Patients With Cancer: Evidence From Randomized Clinical Trials and Observational Studies.

ABSTRACT: Background: The use of direct oral anticoagulants (DOACs) is recommended as the preferred treatment drug in patients with nonvalvular atrial fibrillation (AF). However, the effectiveness and safety of DOACs compared with vitamin K antagonists (VKAs) in patients with cancer and AF are still controversial. Therefore, we performed a meta-analysis regarding the effectiveness and safety of DOACs vs. VKAs in AF patients with cancer. Methods: A search of the Pubmed and EMBASE databases until August 2021 was performed. Adjusted risk ratios (RRs) and 95% confidence intervals (CIs) were pooled using a random-effects model with an inverse variance method. Results: Thirteen studies were deemed to meet the criteria. For the effectiveness outcomes, the use of DOACs compared with VKAs use was significantly associated with decreased risks of stroke or systemic embolism (RR = 0.66, 95% CI: 0.54-0.80) and venous thromboembolism (RR = 0.40, 95% CI: 0.26-0.61), but not ischemic stroke (RR = 0.79, 95% CI: 0.56-1.11), myocardial infarction (RR = 0.78, 95% CI: 0.56-1.11), cardiovascular death (RR = 0.76, 95% CI: 0.53-1.09), and all-cause death (RR = 0.82, 95% CI: 0.43-1.56). For the safety outcomes, compared with VKAs use, the use of DOACs was associated with reduced risks of intracranial bleeding (RR = 0.60, 95% CI: 0.50-0.71) and gastrointestinal bleeding (RR = 0.87, 95% CI: 0.80-0.95). There were no significant differences in major bleeding (RR = 0.87, 95% CI: 0.74-1.04), major or nonmajor clinically relevant bleeding (RR = 0.87, 95% CI: 0.74-1.01), and any bleeding (RR = 0.88, 95% CI: 0.76-1.03). Conclusion: Compared with VKAs, DOACs appeared to have significant reductions in stroke or systemic embolism, venous thromboembolism, intracranial bleeding, and gastrointestinal bleeding, but comparable risks of ischemic stroke, myocardial infarction, cardiovascular death, all-cause death, major bleeding, major or nonmajor clinically relevant bleeding, and any bleeding in patients with AF and cancer.

SUBMITTER: Liu F

PROVIDER: S-EPMC8602680 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and objectiveLeft ventricular thrombus (LVT) formation in patients with acute myocardial infarction (AMI) or cardiomyopathies is not uncommon. The optimal oral anticoagulation therapy for resolving LVT has been under intense debate. Vitamin K antagonists (VKAs) remain the anticoagulant of choice for this condition, according to practice guidelines. Evidence supporting the use of direct oral anticoagulants (DOACs) in the management of LVT continues to grow. We performed a systematic review and meta-analysis to compare the efficacy and safety of DOACs versus VKAs.MethodsA comprehensive literature search was carried out in PubMed, Cochrane Library, Web of Science, Embase, and Scopus databases in July 2023. The efficacy outcomes of this study were thrombus resolution, ischemic stroke, systemic embolism, stroke/systemic embolism, all-cause mortality, and adverse cardiovascular events. The safety outcomes were any bleeding, major bleeding, and intracranial hemorrhage. A total of twenty-seven eligible studies were included in the meta-analysis. Data were analyzed utilizing Stata software version 15.1.ResultsThere was no significant difference between DOACs and VKAs with regard to LVT resolution (RR = 1.00, 95% CI 0.95-1.05, P = 0.99). In the overall analysis, DOACs significantly reduced the risk of stroke (RR = 0.74, 95% CI 0.57-0.96, P = 0.021), all-cause mortality (RR = 0.70, 95% CI 0.57-0.86, P = 0.001), any bleeding (RR = 0.75, 95% CI 0.61-0.92, P = 0.006) and major bleeding (RR = 0.67, 95% CI 0.52-0.85, P = 0.001) when compared to VKAs. Meanwhile, in the sub-analysis examining randomized controlled trials (RCTs), the aforementioned outcomes no longer differed significantly between the DOACs and VKAs groups. The incidences of systemic embolism (RR = 0.81, 95% CI 0.54-1.22, P = 0.32), stroke/systemic embolism (RR = 0.85, 95% CI 0.72-1.00, P = 0.056), intracranial hemorrhage (RR = 0.59, 95% CI 0.23-1.54, P = 0.28), and adverse cardiovascular events (RR = 0.99, 95% CI 0.63-1.56, P = 0.92) were comparable between the DOACs and VKAs groups. A subgroup analysis showed that patients treated with rivaroxaban had a significantly lower risk of stroke (RR = 0.24, 95% CI 0.08-0.72, P = 0.011) than those in the VKAs group.ConclusionWith non-inferior efficacy and superior safety, DOACs are promising therapeutic alternatives to VKAs in the treatment of LVT. Further robust investigations are warranted to confirm our findings.

Project description:BackgroundCurrent guidelines recommend the utilization of direct-acting oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (AF). However, the optimal anticoagulation strategy for AF patients with bioprosthetic heart valves (BPHV) remains controversial. Therefore, we conducted this meta-analysis to explore the effect of DOACs versus vitamin K antagonists (VKAs) in this population.MethodsWe systematically searched the PubMed and Embase databases until November 2021 for studies reporting the effect of DOACs versus VKAs in AF patients with BPHV. Adjusted risk ratios (RRs) and 95% confidence intervals (CIs) were pooled using the random-effects model with an inverse variance method.ResultsWe selected four randomized clinical trials and seven observational studies (2236 DOAC- and 6403 VKAs-users). Regarding the effectiveness outcomes, there were no significant differences between DOACs and VKAs in stroke or systemic embolism (RR = 0.74, 95%CI: 0.50-1.08), ischemic stroke (RR = 1.08, 95%CI: 0.76-1.55), all-cause death (RR = 0.98, 95%CI: 0.86-1.12), and cardiovascular death (RR = 0.85, 95%CI: 0.40-1.80). In terms of the safety outcomes, DOACs was associated with lower risks of major bleeding (RR = 0.70, 95%CI: 0.59-0.82) and intracranial bleeding (RR = 0.42, 95%CI: 0.26-0.70), but the risks of any bleeding (RR = 0.85, 95%CI: 0.65-1.13) and gastrointestinal bleeding (RR = 0.92, 95%CI: 0.73-1.17) are not significantly different when compared with VKAs. The subgroup analysis with follow-up as a covariate revealed that the DOACs had lower risks of SSE (RR = 0.59, 95%CI: 0.37-0.94) and major bleeding (RR = 0.69, 95%CI: 0.58-0.81) in patients with a mean follow-up of more than 24 months, but no statistical differences were found in patients with the follow-up less than 24 months (SSE: RR = 1.10, 95%CI: 0.92-1.32; major bleeding: RR = 0.91, 95%CI: 0.42-2.01).ConclusionsIn AF with BPHV, patients on DOACs experienced a reduced risk of major bleeding and intracranial bleeding compared with VKAs, while the risks of stroke, cardiovascular death, and all-cause mortality were similar.

Project description:BackgroundThere have been ongoing efforts to understand when and how data from observational studies can be applied to clinical and regulatory decision making. The objective of this review was to assess the comparability of relative treatment effects of pharmaceuticals from observational studies and randomized controlled trials (RCTs).MethodsWe searched PubMed and Embase for systematic literature reviews published between January 1, 1990, and January 31, 2020, that reported relative treatment effects of pharmaceuticals from both observational studies and RCTs. We extracted pooled relative effect estimates from observational studies and RCTs for each outcome, intervention-comparator, or indication assessed in the reviews. We calculated the ratio of the relative effect estimate from observational studies over that from RCTs, along with the corresponding 95% confidence interval (CI) for each pair of pooled RCT and observational study estimates, and we evaluated the consistency in relative treatment effects.ResultsThirty systematic reviews across 7 therapeutic areas were identified from the literature. We analyzed 74 pairs of pooled relative effect estimates from RCTs and observational studies from 29 reviews. There was no statistically significant difference (based on the 95% CI) in relative effect estimates between RCTs and observational studies in 79.7% of pairs. There was an extreme difference (ratio < 0.7 or > 1.43) in 43.2% of pairs, and, in 17.6% of pairs, there was a significant difference and the estimates pointed in opposite directions.ConclusionsOverall, our review shows that while there is no significant difference in the relative risk ratios between the majority of RCTs and observational studies compared, there is significant variation in about 20% of comparisons. The source of this variation should be the subject of further inquiry to elucidate how much of the variation is due to differences in patient populations versus biased estimates arising from issues with study design or analytical/statistical methods.

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Effectiveness and Safety of DOACs vs. VKAs in AF Patients With Cancer: Evidence From Randomized Clinical Trials and Observational Studies.

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