Evaluation of mortality after drug-coated stent angioplasty of femoropopliteal lesions

• Conditions: I70.22

• Registration Number: DRKS00019099
• Lead Sponsor: niversitäts-Herzzentrum Bad Krozingen

Brief Summary

From 2010 to 2016 8,377 patients were treated with femoropopliteal lesions. This analysis included 599 patients. Three-hundred-three patients were treated with an uncoated device and 296 patients with a DES. The mean follow-up period was 51.80 ± 23.40 months (range 0–84). For the entire cohort mortality incidence was 32.3% after uncoated treatment and 22.6% after DES (p < .033). For the entire cohort multivariate logistic regression analysis revealed age (p < .001), diabetes mellitus (p = .010), renal insufficiency (p = .001) and RBC 4 (p < .001) as independent predictors for mortality. After propensity score matching mortality incidence was 32.5% after uncoated treatment and 24.1% after DES (p = .264). After propensity score matching, independent mortality predictors were age (p < .001), hyperlipidemia (p = .035), diabetes mellitus (p = .018) and RBC 4 (p < .001). Kaplan–Meier analysis showed that higher paclitaxel dosage was associated with lower mortality

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Study Completion: 2020-05-14
• Results First Posted: 2020-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 599

Inclusion Criteria

Patients who were treated with stent angioplasty at the University Heart Center Freiburg-Bad Krozingen (Bad Krozingen site) due to stenosis of the femoropliteal arteries.

Exclusion Criteria

- Patients who had an intervention only iliacal or at the lower leg arteries
- Patients with an intervention due to stenosis of a femoropliteal/crural bypass
- Patients who have been treated with a paclitaxel-coated catheter iliacal or on the lower leg arteries in the same intervention

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality after treatment of femoropopliteal lesions using drug-coated stent angioplasty and uncoated balloon/stent angioplasty

Secondary Outcome Measures

Name	Time	Method
- Freedom from re-intervention at the target lesion (target lesion revascularisation, TLR).<br>- Restenosis rate <br>- Revascularization-free survival<br>- Time from index intervention to reinvention<br>- cause of death<br>- Number of Paclitaxel device TLRs in Follow-Up