Effectiveness and Safety of Rivaroxaban by General Practitioners　- A Multicenter, Prospective Study in Japanese Patients With Non-Valvular Atrial Fibrillation (GENERAL).

Abstract

BACKGROUND:

Direct oral anticoagulants have become a standard therapy for non-valvular atrial fibrillation (NVAF). However, little is known about their effectiveness/safety when prescribed by general practitioners to treat high-risk populations such as the elderly, those who are frail or have cognitive dysfunction.Methods and Results:In this multicenter, prospective study, a total of 5,717 NVAF patients (mean age 73.9 years) receiving rivaroxaban were registered by general practitioners, with a maximum 3-year follow up (mean 2.0±0.5 years). The primary endpoint was a composite of stroke and systemic embolism (SE). The annual incidence (per 100 person-years) of stroke/SE was 1.23% and for major bleeding, it was 0.63%. Multivariate analyses identified age ≥75 years (hazard ratio [HR]; 2.67, P<0.001) and history of ischemic stroke (HR; 1.89, P=0.005) as significant risk factors of stroke/SE, with history of major bleeding (HR; 14.9, P<0.001) and warfarin use (HR; 2.15, P=0.002) as risk factors for major bleeding events. Neither cognitive dysfunction, defined by the receipt of anti-dementia medications, nor frailty, evaluated by the classification of the Japanese Long-term Care Insurance system, correlated with stroke/SE or major bleeding events.

CONCLUSIONS:

The low incidence of adverse events, including stroke/SE and bleeding, in patients prescribed rivaroxaban by general practitioners supports its use as a safe and efficacious treatment in the standard clinical care of high-risk patient populations.

• Authors: Kengo Kusano, Nobuyoshi Sugishita, Masaharu Akao, Hikari Tsuji, Kunihiko Matsui, Shinya Hiramitsu, Yutaka Hatori, Hironori Odakura, Hiroyuki Kamada, Koji Miyamoto, Hisao Ogawa
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 85 Issue 8 Pg. 1275-1282 (07 21 2021) ISSN: 1347-4820 [Electronic] Japan
• PMID: 33814525 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Rivaroxaban

Topics

• Aged
• Anticoagulants (adverse effects)
• Atrial Fibrillation (complications, drug therapy)
• Embolism
• General Practitioners
• Hemorrhage (chemically induced, epidemiology)
• Humans
• Japan (epidemiology)
• Prospective Studies
• Retrospective Studies
• Rivaroxaban (adverse effects)
• Stroke (epidemiology, etiology, prevention & control)
• Treatment Outcome