心臓手術後の心房細動に対するリバロキサバンとワルファリンの比較 (NEW-AF)

リバロキサバン：プロトロンビンからのトロンビンの形成を刺激する酵素である第Xa因子の直接阻害剤（凝固カスケードの内因性および外因性の両方における重要なステップ）

剤形：1回あたり（経口）

投与量と頻度: 毎晩 20 mg を夕食と一緒に (滴定の必要はありません)。 糸球体濾過率が低下している患者（GFRが15ml/分～50ml/分）の場合、毎晩夕食とともに15mgに減量されます。

期間：30日（術後循環器内科受診後継続可能）

• ザレルト
• 分子データベース (PubChem CID): 6433119

ワルファリン：ビタミンK依存性凝固因子の活性化経路における重要な酵素であるビタミンKエポキシドレダクターゼ複合体1の競合的阻害剤

剤形：1回あたり（経口）

投与量と頻度: 毎晩夕食後 (QHS) に 2 - 5 mg の初期投与量を、INR 2.0 - 3.0 を目標に適切に滴定します (初期投与量は、体重、年齢、性別、併存疾患、および併用薬に基づく)。 INR は、投薬の安定性と投薬計画に応じて、毎日から毎週チェックされます。

期間：30日（術後循環器内科受診後継続可能）

• クマディン
• 分子データベース (PubChem CID): 54678486

Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels

For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences.

Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels

For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences.

The visual analog scale is single answer between 0 and 100 representing the patient's perception of their health state. 0 represents the worst health imaginable and 100 represents the best.

Participants will be administered the PACT-Q2 questionnaire which is comprised of a convenience subscale and a satisfaction subscale.

For the convenience subscale, each of 13 questions is answered on a 1-5 rating scale with higher numbers representing worse outcomes. A sub-scale score is generated by inverting the score from each element and calculating the sum. Range on the inverted scale is 13 - 65. Higher scores represent better outcomes.

For the satisfaction subscale, each of 7 questions is answered on a 1-5 rating scale with higher numbers representing better outcomes. The total score on this subscale is generated by adding up scores from all elements. Range on this subscale is 7-35. Higher scores represent better outcomes.

A composite score is generated by adding up scores from both subscales and recalibrating on a 0-100 scale by adding the scores together and applying the formula: COMPOSITE SCORE=100×(Sum-20)/80. Higher scores represent more favorable outcomes.