Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease.
J Am Coll Cardiol
; 81(4): 358-370, 2023 01 31.
Article
in En
| MEDLINE
| ID: mdl-36697136
ABSTRACT
BACKGROUND:
No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease.OBJECTIVES:
This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx.METHODS:
Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days.RESULTS:
A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR] 1.04; 95% CI 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation 1.04; 95% CI 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency 1.31; 95% CI 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001).CONCLUSIONS:
These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Peripheral Arterial Disease
/
Endovascular Procedures
Type of study:
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Am Coll Cardiol
Year:
2023
Document type:
Article
Affiliation country:
United States