Aortic & peripheral vascular disease

1-Year Outcomes of Transcatheter Arterialization of Deep Veins: PROMISE II and Pooled PROMISE Studies

JACC Cardiovasc IntervPublished Prospective single-arm study with patient-level pooled analysis

Authors' conclusion

1-year outcomes following TADV with the LimFlow System demonstrated durable AFS and limb salvage rates, and improvement in clinical symptoms in no-option CLTI patients who often face major amputation or palliative care.

Study context

Population
Patients with Rutherford class 5/6 chronic limb-threatening ischemia (CLTI) and independently assessed no-option statuspooled analysis n = 137
Participants
105 patients
Outcome
Amputation-free survival (AFS), limb salvage and survival
Follow-up
1 year
Methodological detailsmulticentre
  • Multicentre

Pooled result

As reported in the abstract

AFS, limb salvage and survival (PROMISE II)

Amputation-free survival (AFS)

54.2%

95% CI 45.2–65.1%

Limb salvage

68.7%

95% CI 59.8–78.9%

Survival

79.0%

95% CI 70.2–88.8%

Further pooled results

AFS, limb salvage and survival (pooled PROMISE I, II and UK, n = 137) · 1 year

AFS
66.1% (95% CI: 58.4-74.9%)
Limb salvage
74.4% (95% CI: 67.1-82.5%)
Survival
88.9% (95% CI: 82.9-95.2%)
  • Patient-level pooled analysis

Clinical symptoms and wound status · 1 year

Clinical symptoms and wound status showed improvement through 1 year

Original publication

1-Year Outcomes of Transcatheter Arterialization of Deep Veins: PROMISE II and Pooled PROMISE Studies. JACC Cardiovasc Interv. Published 14 July 2025. doi:10.1016/j.jcin.2025.05.004

Summarised from the published abstract; every number is checked against it

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