Outcomes of Factor Xa Inhibitor-based Regimens Versus Dual Antiplatelet Therapy in Managing Infrageniculate Critical Limb Ischemia Post Angioplasty

Q: What are the key findings of this study?

Factor Xa inhibitor-based regimens with rivaroxaban (75%) and apixaban (72.9%) achieved higher 12-month primary patency rates than DAPT (67.1%; p<0.001) after infrageniculate angioplasty for CLTI.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Critical limb-threatening ischemia (CLTI) undergoing infrageniculate angioplasty (n=145). Intervention: Factor Xa inhibitor plus aspirin (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily plus aspirin 100 mg daily) vs. Dual antiplatelet therapy (DAPT) with clopidogrel 75 mg daily plus aspirin 100 mg daily. Primary outcome: Primary patency rate (proportion of patients with no reintervention within 12 months) (p=<0.001).

Q: What does this research mean for the field?

Factor Xa inhibitor-based regimens combined with aspirin achieve higher 12-month primary patency and clinical improvement than dual antiplatelet therapy in patients with critical limb ischemia undergoing infrageniculate angioplasty. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To compare the efficacy and safety of factor Xa inhibitor–based regimens versus dual antiplatelet therapy following infrageniculate angioplasty in patients with critical limb-threatening ischemia.

Abdullah Alhaizaey

doi:10.53365/nrfhh.2736

September 29, 2026Natural Resources for Human Health

Outcomes of Factor Xa Inhibitor-based Regimens Versus Dual Antiplatelet Therapy in Managing Infrageniculate Critical Limb Ischemia Post Angioplasty

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Key result

Factor Xa inhibitors linked to ~8 percentage points higher 12-month patency vs. DAPT after CLTI angioplasty.

P<0.001
n=145

Why the study?

The effectiveness of DAPT in maintaining vessel patency after infrageniculate endovascular revascularization for CLTI remains uncertain, and factor Xa inhibitor-based dual pathway inhibition may offer improved outcomes.

Do factor Xa inhibitor-based regimens (apixaban or rivaroxaban plus aspirin) improve 12-month primary patency rates compared to dual antiplatelet therapy (clopidogrel plus aspirin) in patients with critical limb-threatening ischemia undergoing infrageniculate angioplasty?

Key Points

To compare the efficacy and safety of factor Xa inhibitor–based regimens versus dual antiplatelet therapy following infrageniculate angioplasty in patients with critical limb-threatening ischemia.
Multicenter retrospective cohort study of 145 patients with critical limb-threatening ischemia (Rutherford class 4–6) undergoing infrageniculate angioplasty between January 2022 and December 2023.
Patients received post-procedural antithrombotic regimens consisting of apixaban plus aspirin (n=37), rivaroxaban plus aspirin (n=32), or dual antiplatelet therapy with clopidogrel plus aspirin (n=76).
At 12 months, primary patency was significantly higher with rivaroxaban (75%) and apixaban (72.9%) than with dual antiplatelet therapy (67.1%) (p < 0.001); primary-assisted patency was 87.5% and 83.7% versus 78.9%, respectively (p < 0.001).
Clinical improvement occurred in 81% of patients receiving apixaban and 72% receiving rivaroxaban, compared with 9.2% receiving dual antiplatelet therapy (p < 0.001).
Safety outcomes did not differ significantly among groups, including hematoma (p=0.3), bleeding from other sources (p=0.6), myocardial infarction (p=0.5), ischemic stroke (p=0.5), or cardiovascular death (p=0.6).

Study Design

Type

Cohort (n=145)

Multicenter

Yes

Structured PICO

Do factor Xa inhibitor-based regimens (apixaban or rivaroxaban plus aspirin) improve 12-month primary patency rates compared to dual antiplatelet therapy (clopidogrel plus aspirin) in patients with critical limb-threatening ischemia undergoing infrageniculate angioplasty?

P

Population

145 adults (mean age 60 years, 26.2% female) in Saudi Arabia with critical limb-threatening ischemia (Rutherford class 4-6) undergoing infrageniculate angioplasty, followed for 12 months.

E

Exposure

Factor Xa inhibitor-based dual pathway inhibition for 12 months post-angioplasty, stratified into two groups: Group 1 received apixaban 2.5 mg twice daily plus aspirin 100 mg daily (n=37, Asser Central Hospital), and Group 2 received rivaroxaban 10 mg once daily plus aspirin 100 mg daily (n=32, Armed Forces Hospital - Southern Region).

C

Comparator

Conventional dual antiplatelet therapy (DAPT) with clopidogrel 75 mg daily plus aspirin 100 mg daily for 12 months post-angioplasty (n=76, Alhaya National Hospital).

O

Outcome

Primary patency rate (PPR) at 12 months, defined as the proportion of patients who did not require any reintervention within 12 months following the index angioplasty procedure.hard clinical

Main Result

Absolute Event Rate: 75% vs 67.1%

p-value: p=<0.001

In patients with critical limb-threatening ischemia undergoing infrageniculate angioplasty, dual pathway inhibition with apixaban or rivaroxaban plus aspirin was associated with significantly higher 12-month patency rates and clinical improvement compared to clopidogrel-based DAPT, without increasing bleeding risk.

Limitations

Relatively small sample size, particularly in the apixaban and rivaroxaban groups, reducing statistical power for less frequent outcomes
Absence of randomization in group allocation introducing potential selection bias
Follow-up limited to 12 months, leaving longer-term outcomes unassessed
Adherence to prescribed medications and dose modifications were not monitored
Significant baseline differences in lesion characteristics and comorbidities across groups
Quality-of-life parameters and functional recovery outcomes were not evaluated
Medication adherence and dose modifications were not monitored
Significant baseline variability in lesion characteristics and comorbid conditions (e.g., diabetes, hypertension) across groups
Did not evaluate quality-of-life parameters or functional recovery outcomes

Implication

Supports dual-pathway inhibition post-infrageniculate angioplasty in CLTI; extends VOYAGER PAD but remains hypothesis-generating pending RCTs.

Abstract

Background: Critical limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease and is associated with high rates of limb loss and mortality. Although dual antiplatelet therapy (DAPT) is commonly used following infrageniculate endovascular revascularization, its effectiveness in maintaining vessel patency remains uncertain. Factor Xa inhibitor–based dual pathway inhibition may offer improved outcomes in this high-risk population.Patients and Methods: This multicenter retrospective cohort study included 145 patients with CLTI (Rutherford class 4–6) who underwent infrageniculate angioplasty between January 2022 and December 2023. Patients were stratified according to post-procedural antithrombotic therapy into three groups: apixaban plus aspirin (n = 37), rivaroxaban plus aspirin (n = 32), and DAPT with clopidogrel plus aspirin (n = 76). The primary outcome was primary patency rate at 12 months. Secondary outcomes included primary-assisted patency, clinical improvement based on Rutherford classification, limb-related outcomes, and safety endpoints including bleeding, hematoma, myocardial infarction, ischemic stroke, and cardiovascular death.Results: At 12 months, primary patency was significantly higher in the rivaroxaban (75%) and apixaban (72.9%) groups compared with the DAPT group (67.1%) (p < 0.001). Primary-assisted patency was also superior in the rivaroxaban (87.5%) and apixaban (83.7%) groups versus DAPT (78.9%) (p < 0.001). Clinical improvement was observed in 81% of patients receiving apixaban and 72% receiving rivaroxaban, compared with 9.2% in the DAPT group (p < 0.001). Rates of amputation, wound healing, and adverse safety outcomes did not differ significantly among groups.Conclusion: In patients with CLTI undergoing infrageniculate angioplasty, factor Xa inhibitor–based regimens combined with aspirin were associated with superior 12-month patency and greater clinical improvement compared with conventional DAPT, without an increased risk of adverse events. These findings support dual pathway inhibition as a promising antithrombotic strategy in this high-risk population.

Discussion

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Cite This Study

Abdullah Alhaizaey (2026) conducted a cohort in Critical limb-threatening ischemia (CLTI) undergoing infrageniculate angioplasty (n=145). Factor Xa inhibitor plus aspirin (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily plus aspirin 100 mg daily) vs. Dual antiplatelet therapy (DAPT) with clopidogrel 75 mg daily plus aspirin 100 mg daily was evaluated on Primary patency rate (proportion of patients with no reintervention within 12 months) (p=<0.001). Factor Xa inhibitor-based regimens with rivaroxaban (75%) and apixaban (72.9%) achieved higher 12-month primary patency rates than DAPT (67.1%; p<0.001) after infrageniculate angioplasty for CLTI.

synapsesocial.com/papers/6ae28e0ecbadf70daf6c3fec https://doi.org/10.53365/nrfhh.2736

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Outcomes of Factor Xa Inhibitor-based Regimens Versus Dual Antiplatelet Therapy in Managing Infrageniculate Critical Limb Ischemia Post Angioplasty

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Outcomes of Factor Xa Inhibitor-based Regimens Versus Dual Antiplatelet Therapy in Managing Infrageniculate Critical Limb Ischemia Post Angioplasty

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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