心房細動（SINGLE-AF）患者における中間期脳卒中リスクに対する非ビタミンK拮抗経口抗凝固薬の有効性と安全性

介入なし：非抗凝固群

2年間の抗凝固薬を除く標準治療

実験的：Anticoagulation group(DOAC group)

Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) or rivaroxaban 20mg once daily (15mg once daily if meets dose-reduction criteria) for 2 years

薬：Anticoagulation group(DOAC group)

Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) or rivaroxaban 20mg once daily (15mg once daily if meets dose-reduction criteria) for 2 years

複合結果

脳卒中/全身塞栓症、主要な出血、心血管死を含む複合結果

脳卒中

虚血性脳卒中は、明白な症状を伴う中枢神経系の梗塞 (脳、脊髄、または虚血に起因する網膜細胞死) を具体的に指しますが、定義上、無症状の梗塞は既知の症状を引き起こしません。 脳卒中には、脳内出血やくも膜下出血も広く含まれます。

大出血

国際血栓止血学会 (ISTH)/Scientific and Standardization Committee (SSC) の定義と出血評価ツールは、出血症状の報告を標準化するのに役立ちます。

1. 致命的な出血。 頭蓋内、脊髄内、眼内、後腹膜、関節内または心膜、またはコンパートメント症候群を伴う筋肉内などの重要な領域または臓器における症候性出血。 および/または 3. 2 g/dL (1.24 mmol/L) 以上のヘモグロビンレベルの低下を引き起こす出血、または 2 単位以上の全血または赤血球の輸血につながる出血。

全身塞栓症

全身塞栓症とは、動脈循環における塞栓症を指し、末端臓器灌流の突然の喪失の臨床的証拠と客観的証拠の両方によって定義されます。

Cardiovascular Death

Death due to myocardial infarction, sudden cardiac death, heart failure, stroke, cardiovascular procedures, cardiovascular hemorrhage, and any case of death in which a cardiovascular cause cannot be excluded as adjudicated by a clinical events committee.

Clinically Relevant Non-Major Bleeding (CRNMB)

1. Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: i. requiring medical intervention by a healthcare professional ii. leading to hospitalization or increased level of care iii. prompting a face to face (i.e., not just a telephone or electronic communication) evaluation 2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1: i. Fatal bleeding, and/or ii. Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or iii. Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.

Death

The permanent stopping of all the vital bodily activities

Transient ischemic attack (TIA)

TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.

Myocardial infarction

The definition of myocardial infarction (MI) was based on the Third Universal MI definition

Hospital admission

Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury.