Atrial Fibrillation and Mitral Regurgitation: Clinical Performance of Direct Oral Anticoagulants in a Real-World Setting

Abstract

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia and is frequently present in patients with mitral regurgitation (MR). Currently, there is a lack of real-world evidence specifically addressing the clinical performance of direct oral anticoagulants (DOACs) in patients with AF and concomitant MR. Therefore, the aim of the present study was to assess the efficacy and safety profile of DOACs therapy in patients with AF and MR. Methods: Data for this study were sourced from the Atrial Fibrillation Research Database in the Department of Cardiology at Monaldi Hospital. The database was queried for AF patients with MR who were prescribed DOACs therapy. The primary safety outcome was defined as the annual incidence rate of major bleeding events and the primary effectiveness outcome as the annual incidence rate of all events classified as ischemic stroke, transient ischemic attacks, and systemic embolisms. Results: Consecutive AF patients with concomitant mild to severe MR who received DOACs therapy (n = 259) were included. Patients were dichotomized in 2 groups according to MR severity: a mild-to-moderate group (MR 1-2+; n = 151) and a moderate-to-severe group (MR 3-4+; n = 108). The incidence rate of major bleedings was significantly higher in MR 3-4+ group (3.92%) compared with the MR 1-2+ group (1.18%; hazard ratio [HR]: 3.2; 95% CI: 1.4-7.3; P = .0059). The incidence rate of thromboembolic events between MR 3-4+ group (0.66%) and MR 1-2+ group (0.62%) was not significantly different (HR: 0.75; P = .823). Conclusions: In the present study, there was no difference in the efficacy profile of DOACs between AF patients with mild-to-moderate and moderate-to-severe MR. Considering the increased bleeding risk, a close and careful follow-up should be warranted for patients with moderate-to-severe MR.

Gender Differences in Atrial Fibrillation: From the Thromboembolic Risk to the Anticoagulant Treatment Response

“…The reasons for the known greater thromboembolic risk in women than in men remain unclear but may include older age, under-treatment with anticoagulant therapy, and poor anticoagulation control [ 93 ]. Many studies [ 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 ] were very well designed to assess the effectiveness of NOACs versus VKAs for thromboembolic risk prevention in NVAF, but sex-associated risk during NOACs treatment is not still understood. Law et al [ 102 ] compared the effectiveness and safety outcomes of NOACs versus VKAs in 4972 men and 4834 women, showing that NOACs use was associated with a lower risk of intracranial hemorrhages (ICH) (HR: 0.16, 95% CI [0.06, 0.40]) and all-cause mortality (HR: 0.55, 95% CI [0.39, 0.77]) in women but not in men without significant differences in terms of stroke and TE incidence.…”

Antioxidant Properties of Oral Antithrombotic Therapies in Atherosclerotic Disease and Atrial Fibrillation

“…DOACs achieved solid class I recommendations thanks to their comparable efficacy and better safety profile as compared to VKAs. These data derive both from several randomized clinical trials (RCTs) [ 9 , 10 , 11 ] and real-world observational studies of patient subgroups less represented in RCTs, such as severely obese patients [ 12 , 13 ], cancer patients [ 14 , 15 ], elderly patients [ 16 , 17 , 18 , 19 , 20 , 21 ], or patients who had undergone bioprosthetic valve replacement or prior repair [ 22 , 23 , 24 ].…”

Anti-Inflammatory and Anticancer Effects of Anticoagulant Therapy in Patients with Malignancy

“…Direct oral anticoagulants (DOACs) have overcome the drawbacks of both VKAs and parenteral LWMHs, i.e., oral administration without the need for routine blood monitoring, good therapeutic adherence, and fewer intracranial hemorrhages. Based on this evidence, DOACs are considered the first choice when anticoagulation therapy is needed in different clinical scenarios [ 6 , 7 , 8 , 9 ], even in that subgroups of patients under-represented in the RCTs [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ]. Recently, DOACs were tested in cancer patients [ 24 , 25 , 26 , 27 , 28 ], and according to the international guidelines, rivaroxaban, apixaban, and edoxaban are considered the first-line anticoagulant therapy for patients with malignancy, except for those with GI and genitourinary cancers [ 29 , 30 ].…”