p.54 抽出テキスト

CLINICAL STATEMENTS AND GUIDELINES

January 2, 2024 Circulation. 2024;149:e1–e156. DOI: 10.1161/CIR.0000000000001193 e54

Joglar et al 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation

events in patients with AF and concomitant CCD (at least 12 months after revascularization or CAD not requiring coronary revascularization) compared with oral anticoagulation monotherapy. A recent landmark clinical trial showed that rivaroxaban monotherapy significantly decreased the primary composite outcome (stroke, systemic embolism, MI, unstable angina requiring revascularization, or death from any cause) and decreased the risk of major bleeding compared with the combination therapy.1 The subgroup analysis of the previously mentioned clinical trial in patients with AF only after coronary stenting and another clinical trial corroborated the main findings in a similar population.2,3 Recommendation-Specific Supportive Text 1.	 An RCT compared the rivaroxaban monotherapy

(n=1107) with the combination of rivaroxaban and a single APT (n=1108) in patients with AF and CCD or CAD not requiring revascularization.1 The primary efficacy outcome was the composite of stroke, systemic embolism, MI, unstable angina requiring revascularization, or death from any cause. Rivaroxaban monotherapy was noninferior to dual therapy for the primary outcome (4.14% versus 5.75%/patient-year; HR, 0.72 [95% CI, 0.55-0.95]) and was superior for primary safety endpoint of major bleeding (1.62% versus 2.76%/ patient-year; HR, 0.59 [95% CI, 0.39-0.89]) compared with combination therapy. Another clinical trial also showed the composite outcome of death from all causes, MI, stroke, or systemic embolism (15.7% versus 13.6%; HR, 1.16 [95% CI, 0.79- 1.72]; P=0.20 for noninferiority); the major bleeding risk in the oral anticoagulation monotherapy group was numerically lower than the combination therapy group (7.8% versus 10.4%; HR, 0.73 [95% CI, 0.44-1.20]).2 However, this trial was terminated prematurely because of slow enrollment and did not have enough power for noninferiority; thus, it was inconclusive. Of note, both clinical trials excluded patients with history of stent thrombosis. Further investigation of oral anticoagulation therapy in patients with a history of stent thrombosis is needed.

6.8.3 Peripheral Artery Disease (PAD)

Recommendation for PAD Referenced studies that support the recommendation are summarized in the Online Data Supplement. COR LOE Recommendation

2a B-NR 1.	 In patients with AF and concomitant stable PAD,

monotherapy oral anticoagulation is reasonable over dual therapy (anticoagulation plus aspirin or P2Y12 inhibitors) to reduce the risk of bleeding.1–5

Synopsis Antiplatelet monotherapy is the standard of care for patients with symptomatic PAD and reasonable in asymp- tomatic PAD with ankle-brachial index ≤0.90 to reduce the risk of MI, stroke, and vascular death.6 The 2016 AHA/ACC PAD guidelines recommend against anticoagulation for ischemic event risk reduction in the general PAD population (COR 3; LOE A) due to increased risk of bleeding without significant reduction in ischemic events compared with antiplatelet monotherapy,6,7 without making specific recommendations for patients with comorbid PAD and AF. Conversely, anticoagulation is recommended for patients with AF at intermediate-to-high risk of stroke due to the inferiority of APT to prevent stroke and systemic thromboembolism in this population. Subgroup analysis of landmark DOAC clinical trials demonstrate comparable efficacy and safety of DOACs compared with warfarin among patients with AF with and without PAD.2–4 Clinical trial evidence is lacking to guide decisions regarding DAT in the setting of concomitant AF and PAD (whether stable PAD or after lower extremity revascularization). Observational studies of patients with concomitant AF and PAD treated with OAC monotherapy compared with dual therapy (OAC plus antiplatelet) found an increased risk of bleeding on dual therapy without reduction in major adverse cardiac events.5,8 However, an important limitation of these studies was the lack of PAD-specific outcomes such as acute or critical limb ischemia, revascularization, or amputation as primary or secondary outcomes.5,8

Recommendation-Specific Supportive Text 1.	 In the WAVE (Warfarin Antiplatelet Vascular

Evaluation) trial of patients with PAD but without AF, dual therapy (antiplatelet plus warfarin) did not reduce the primary outcome of MI, stroke, cardiovascular death (RR, 0.92 [95% CI, 0.73- 1.16]; P=0.48) compared with monotherapy (antiplatelet alone), and dual therapy increased the risk of life-threatening bleeding (RR, 3.41 [95% CI, 1.84-6.35]; P<0.001).7 Meta-analysis of 3 RCT subgroup analyses (ENGAGE AF-TIMI 48, ARISTOTLE, ROCKET AF; total N=2 564) compared safety and efficacy outcomes between warfarin and DOACs in patients with concomitant AF and PAD.1–4 The meta-analysis demonstrated similar efficacy for DOACs compared with warfarin, including stroke and systemic embolism (RR, 0.93 [95% CI, 0.61-1.42]; P=0.73), all-cause death (RR, 0.91 [95% CI, 0.70-1.19]; P=0.50), and MI (RR, 1.10 [95% CI, 0.64-1.90]; P=0.74), without a statistically significant difference in the risk of major bleeding (RR, 1.12 [95% CI, 0.70-1.81]; P=0.63) or ICH (RR, 0.54 [95% CI, 0.16-1.85]; P=0.33).1 In ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II),5 among AF patients with concomitant vascular disease (CAD or PAD), major adverse cardiac or neurological events and bleeding events were compared

Downloaded from http://ahajournals.org by on October 7, 2026