Effect of concomitant antiplatelet therapy on ischemic and hemorrhagic events in patients taking oral anticoagulants for nonvalvular atrial fibrillation in daily clinical practice

Abstract

Purpose Antiplatelet therapy (APT) is challenging in patients taking oral anticoagulants (OACs) for nonvalvular atrial fibrillation (NVAF) with concomitant atherosclerotic diseases. We scrutinized the generalizability of recent randomized clinical trials showing OAC use alone was superior to OAC plus antiplatelet use in patients with NVAF and coronary artery diseases (CAD). Methods We conducted a historical multicenter registry at 71 centers in Japan. The inclusion criterion was taking OACs for NVAF. The exclusion criteria were mechanical heart valves or history of pulmonary thrombosis or deep vein thrombosis. Consecutive patients (N = 7826) were registered in February 2013 and were followed until February 2017. The co‐primary endpoints were ischemic events and major bleedings. Secondary endpoints were ischemic stroke, hemorrhagic stroke, and all‐cause mortality. Results The mean patient age was 73 years; 67% were men. Antiplatelets were administered in 25% of patients and 27% had history of CAD. Cumulative incidences of ischemic events and major bleedings at 4 years were 5.9% and 9.6% in the APT group and 5.3% and 7.0% in the No‐APT group, respectively. The adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) of the APT group for ischemic events and major bleedings were 1.12 (0.84–1.49) and 1.26 (1.01–1.57), respectively. The adjusted HRs (95% CIs) for ischemic stroke, hemorrhagic stroke, and all‐cause mortality were 1.16 (0.86–1.57), and 1.31 (0.70–2.48), and 1.02 (0.82–1.26), respectively. Conclusions APT in patients taking OACs for NVAF did not prevent ischemic events but significantly increased major bleedings in the real‐world setting.

Association between Acid-Suppressive Drugs and Clinical Outcomes in Patients with Nonvalvular Atrial Fibrillation

“…Those with a history of stroke or major bleeding were included. The Institutional Review Boards of all 71 participating centers approved the study protocol (electronic supplementary Table 1), which conforms to the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan [15][16][17]. Written informed consent was replaced with the opt-out method in line with the guidelines.…”

“…This study was a subanalysis of an historical registry study from 71 centers in Japan [ 15 , 16 ]. We included patients with NVAF, taking VKAs, on 2 February 2013 and excluded those with mechanical heart valves or a history of pulmonary thrombosis or deep vein thrombosis.…”

“…Clinical research coordinators reviewed the hospital charts to collect clinical information [ 15 , 16 ]. We collected follow-up information such as patient characteristics, laboratory data, medication use, risk for ischemic stroke (CHADS 2 score), and risk for hemorrhagic stroke (HAS-BLED score) at 1, 2, 3, and 4 years for the same procedure.…”

Effect of current smoking on ischemic events in patients with atrial fibrillation taking vitamin K antagonist

“…We conducted a subanalysis of a historical registry study from 71 centers in Japan, published in 2021 [ 11 ]. Patients with AF taking a VKA on February 26, 2013, were included in this study.…”

“…Patients with mechanical heart valves or a history of pulmonary thrombosis or deep vein thrombosis were excluded. Participants were followed until February 25, 2017 [ 11 ]. We included those with a history of strokes or major bleedings [ 11 ].…”