Comparison of clinical outcomes of edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonists in patients with atrial fibrillation in Germany: A real-world cohort study

Marston, X.; Wang, R.; Yeh, Yu-Chen; Zimmermann, Lisa; Ye, X.; Gào, Xīn; Brüggenjürgen, Bernd; Unverdorben, Martin

doi:10.1016/j.ijcard.2021.11.008

Cited by 20 publications

(22 citation statements)

References 28 publications

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“…Overall, the present study demonstrated that edoxaban was generally more effective than phenprocoumon for the prevention of effectiveness and safety events in NVAF patients. These findings are in line with other real-world studies on the comparative effectiveness and safety of edoxaban vs VKA from Paschke et al and Marston et al assessed in different German databases [ 9 , 29 ]. The study by Paschke et al, which was conducted based on a large sample of AF patients ( n = 837,430), included the highest number of edoxaban patients ( n = 14,666).…”

Section: Discussionsupporting

confidence: 91%

“…Edoxaban treatment revealed a numerically lower risk of stroke/SE and was associated with a significantly lower risk for major bleeding in comparison to phenprocoumon. The comparison of outcomes to previous real-world studies [ 9 , 10 , 24 , 29 ] showed largely consistent results and strengthens the confidence in our findings. Importantly, our results confirm the findings of the edoxaban pivotal trial ENGAGE AF-TMI 48 in a German real-world population that included geriatric patients as the most vulnerable subgroup with a high burden of multimorbidity and frailty.…”

Section: Discussionsupporting

confidence: 90%

“…In comparison with VKA, adjusted combined risks of ischemic stroke or SE were lower for edoxaban patients (HR: 0.64, 95% CI: 0.60–0.87). In addition, the risk of major bleeding was lower for edoxaban compared to VKA (HR: 0.47, 95% CI: 0.40–0.55) [ 29 ]. Although the study by Marston et al encompassed a smaller sample of edoxaban patients and had a shorter follow-up for edoxaban patients than the present study, these results also indicate a better efficacy and safety profile of edoxaban compared with VKA.…”

Section: Discussionmentioning

confidence: 99%

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Clinical outcomes in patients receiving edoxaban or phenprocoumon for prevention of stroke in atrial fibrillation: a German real-world cohort study

et al. 2022

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Background Appropriate and timely anticoagulant therapy with vitamin K antagonists (VKAs) or non-vitamin K oral antagonists (NOACs) is essential for stroke prevention in non-valvular atrial fibrillation (NVAF). Comparative data regarding effectiveness and safety for edoxaban vs phenprocoumon, the predominant VKA in Germany, are scarce. Objectives The study evaluates effectiveness and safety of edoxaban vs phenprocoumon in NVAF patients in a German real-world setting. Methods German statutory health insurance claims data of the Institute for Applied Health Research Berlin (InGef) Research Database from 2014 until 2019 were analyzed. In NVAF patients, new users of edoxaban and phenprocoumon were compared to assess effectiveness (stroke/systemic embolism (SE)) and safety (bleeding) during therapy. Hazard ratios (HR) were estimated through multiple outcome-specific cox proportional hazard models adjusting for baseline characteristics. Outcomes of geriatric patients were analyzed in subgroup analyses. Results Between 2015 and 2018, 7,975 and 13,319 NVAF patients newly initiated treatment with edoxaban or phenprocoumon. After adjusting for baseline confounders, the risk of stroke/SE (HR: 0.85, 95% CI: 0.70–1.02) was numerically but not significantly lower, while the risk of major bleeding (HR: 0.69, 95% CI: 0.58–0.81) was significantly lower for edoxaban. In the geriatric subgroups, homogenous results compared to the main analysis were obtained. Conclusion The results of this real-world analysis indicated better effectiveness and safety outcomes in patients with NVAF initiating edoxaban treatment compared to phenprocoumon. The findings confirm that the beneficial effects observed in the pivotal ENGAGE AF-TMI 48 trial can also be achieved in real-world use of edoxaban.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Clinical outcomes in patients receiving edoxaban or phenprocoumon for prevention of stroke in atrial fibrillation: a German real-world cohort study

et al. 2022

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“…The risks of various bleeding complications reported in pivotal RCTs and real-world studies comparing DOACs to VKAs (warfarin) for the prevention of stroke or systemic embolism (SE) in patients with NVAF are presented in Table 2 [ 6 – 12 ].…”

Section: Risk Of Bleeding Complications Under Different Oral Anticoag...mentioning

confidence: 99%

“…Compared to other DOACs or VKAs, there is scant real-world evidence on the efficacy and safety of edoxaban, which is the last licensed DOAC. In the only study available on AF patients from a large German health insurance database (globally enrolling 21,038 patients), edoxaban demonstrated a favorable safety profile with lower risk of MB compared to rivaroxaban (HR 0.74) and VKA (HR 0.47), while no differences in the risk of MB were found between edoxaban and apixaban or dabigatran [ 12 ].…”

Section: Risk Of Bleeding Complications Under Different Oral Anticoag...mentioning

confidence: 99%

Risk and Management of Bleeding Complications with Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Venous Thromboembolism: a Narrative Review

et al. 2022

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Atrial fibrillation (AF) and venous thromboembolism (VTE) are highly prevalent conditions with a significant healthcare burden, and represent the main indications for anticoagulation. Direct oral anticoagulants (DOACs) are the first choice treatment of AF/VTE, and have become the most prescribed class of anticoagulants globally, overtaking vitamin K antagonists (VKAs). Compared to VKAs, DOACs have a similar or better efficacy/safety profile, with reduced risk of intracerebral hemorrhage (ICH), while the risk of major bleeding and other bleeding harms may vary depending on the type of DOAC. We have critically reviewed available evidence from randomized controlled trials and observational studies regarding the risk of bleeding complications of DOACs compared to VKAs in patients with AF and VTE. Special patient populations (e.g., elderly, extreme body weights, chronic kidney disease) have specifically been addressed. Management of bleeding complications and possible resumption of anticoagulation, in particular after ICH and gastrointestinal bleeding, are also discussed. Finally, some suggestions are provided to choose the optimal DOAC to minimize adverse events according to individual patient characteristics and bleeding risk.

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Platelet-rich fibrin ensures hemostasis after single-tooth removal under factor Xa inhibitors — a clinical prospective randomized split-mouth study

Kyyak,

Jari,

Heimes

et al. 2023

Clin Oral Invest

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Objectives In this prospective, double-blinded, randomized split-mouth study, the local hemostatic effect of platelet-rich fibrin (PRF) inserted into the extraction socket in patients taking factor Xa (FXa) inhibitors (apixaban, rivaroxaban, edoxaban) was compared to a hemostatic gelatine sponge (GS) as the “therapeutic gold standard” without withdrawal of oral anticoagulant therapy. Materials and methods Single-tooth extraction was conducted under local anesthesia in n = 21 patients using a split-mouth design (42 teeth). Using a double-blind approach, the extraction socket on one side of the jaw was filled with PRF and on the other with a GS. Bleeding was assessed immediately after surgery, in 30 min, 1 h, 1.5 h, and on follow-up appointments in 24 h and on the 7th day. Results In 67% of cases, mild postoperative oozing could be stopped 30–90 min after tooth extraction via gauze pressure without any delayed bleeding. Concerning bleeding events, there was no difference among the PRF and GS groups and no significant difference among rivaroxaban, apixaban, and edoxaban (all p > 0.15). Conclusion PRF and GS are reliable hemostatic methods in postextraction sockets of patients taking FXa inhibitors. Clinical relevance Consequently, there is no need to discontinue FXa inhibitors because of a single-tooth removal, eliminating the risk of thrombus formation.

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Comparison of clinical outcomes of edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonists in patients with atrial fibrillation in Germany: A real-world cohort study

Cited by 20 publications

References 28 publications

Clinical outcomes in patients receiving edoxaban or phenprocoumon for prevention of stroke in atrial fibrillation: a German real-world cohort study

Clinical outcomes in patients receiving edoxaban or phenprocoumon for prevention of stroke in atrial fibrillation: a German real-world cohort study

Risk and Management of Bleeding Complications with Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Venous Thromboembolism: a Narrative Review

Platelet-rich fibrin ensures hemostasis after single-tooth removal under factor Xa inhibitors — a clinical prospective randomized split-mouth study

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