Contemporary outcomes in no-option chronic limb-threatening ischemia

Anahita Dua1, Richard J Powell2, Arthur C Lee3

  • 1Division of Vascular Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. adua1@mgh.harvard.edu.

Scientific Reports
|July 8, 2025
PubMed

Insights

Outcomes for "no-option" patients with chronic limb-threatening ischemia are poor. Within one year, nearly half experienced major amputation and one-third died, underscoring the urgent need for new limb salvage treatments.

Area of Science:

  • Vascular Surgery
  • Cardiology
  • Public Health

Background:

  • Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease with increasing incidence.
  • A significant subset of CLTI patients are classified as "no-option," facing high risks of limb loss and mortality, particularly in underrepresented groups.
  • Current treatment paradigms offer limited options for these complex patients, necessitating research into novel interventions.

Purpose of the Study:

  • To evaluate contemporary, real-world outcomes for patients with no-option chronic limb-threatening ischemia.
  • To assess the 1-year amputation-free survival rate in this high-risk patient cohort.
  • To identify the rates of major/minor amputation, mortality, and functional status post-intervention.

Main Methods:

  • An observational study involving 180 patients diagnosed with no-option CLTI across 22 US centers.
  • The primary endpoint was defined as amputation-free survival at 1 year, encompassing freedom from death and above-ankle amputation.
  • Data collected included patient demographics, comorbidities (diabetes, heart failure, end-stage renal disease), and clinical outcomes.

Main Results:

  • The 1-year amputation-free survival rate was 37%.
  • Major amputation occurred in 45% of patients, and 33% died within the study year.
  • Among survivors, two-thirds had persistent non-healing ulcers, 44% underwent minor amputation, and 83% required ambulatory assistance.

Conclusions:

  • Patients with no-option CLTI face devastating outcomes, with approximately half undergoing major amputation and one-third dying within one year.
  • The high rates of amputation, mortality, and persistent morbidity highlight a critical unmet need for innovative limb salvage strategies.
  • Further research and development of novel therapeutic interventions are urgently required to improve outcomes for this vulnerable patient population.

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