Direct oral anticoagulants had a better efficacy and safety profile than warfarin in atrial fibrillation patients with diabetes, with rivaroxaban yielding the lowest risk index for stroke (RI=0.08).
Systematic Review (n=71,653)
Do DOACs improve efficacy and safety outcomes compared to warfarin in atrial fibrillation patients with and without diabetes mellitus?
DOACs are an effective and safe alternative to warfarin in atrial fibrillation patients with diabetes mellitus, with rivaroxaban demonstrating the most favorable risk index for stroke and cardiovascular death.
Diabetes mellitus (DM) represents an independent risk factor for chronic AF and is associated with unfavorable outcomes. We aimed to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF), with and without diabetes mellitus (DM), using a new risk index (RI) defined as: RI =Rate of EventsRate of Patients at Risk. In particular, an RI lower than 1 suggests a favorable treatment effect. We searched MEDLINE, MEDLINE In-Process, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials. The risk index (RI) was calculated in terms of efficacy (rate of stroke/systemic embolism (stroke SEE)/rate of patients with and without DM; rate of cardiovascular death/rate of patients with and without DM) and safety (rate of major bleeding/rate of patients with and without DM) outcomes. AF patients with DM (n = 22,057) and 49,596 without DM were considered from pivotal trials. DM doubles the risk index for stroke/SEE, major bleeding (MB), and cardiovascular (CV) death. The RI for stroke/SEE, MB, and CV death was comparable in patients treated with warfarin or DOACs. The lowest RI was in DM patients treated with Rivaroxaban (stroke/SEE, RI = 0.08; CV death, RI = 0.13). The RIs for bleeding were higher in DM patients treated with Dabigatran (RI110 = 0.32; RI150 = 0.40). Our study is the first to use RI to homogenize the efficacy and safety data reported in the DOACs pivotal studies against warfarin in patients with and without DM. Anticoagulation therapy is effective and safe in DM patients. DOACs appear to have a better efficacy and safety profile than warfarin. The use of DOACs is a reasonable alternative to vitamin-K antagonists in AF patients with DM. The RI can be a reasonable tool to help clinicians choose between DOACs or warfarin in the peculiar set of AF patients with DM.
Acanfora et al. (Tue,) conducted a systematic review in Atrial fibrillation with and without diabetes mellitus (n=71,653). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on Risk index (RI) for stroke/systemic embolism, major bleeding, and cardiovascular death. Direct oral anticoagulants had a better efficacy and safety profile than warfarin in atrial fibrillation patients with diabetes, with rivaroxaban yielding the lowest risk index for stroke (RI=0.08).