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

• Conditions: I70.22

• Registration Number: DRKS00019039
• Lead Sponsor: niversitäts-Herzzentrum Bad Krozingen

Brief Summary

Overall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p ¼ 0.009), hyperlipidemia (p ¼ 0.010), diabetes mellitus (p ¼ 0.010), renal insufficiency (p ¼ 0.007), stroke (p ¼ 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p ¼ 0.035), age (p < 0.001), stroke (p ¼ 0.025), and renal insufficiency (p ¼ 0.007).

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-10-15
• Study Start: 2019-11-15
• Results First Posted: 2020-09-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Patients with interventions of the femoropopliteal arteries performed at the University Heart Center Freiburg-Bad Krozingen (Bad Krozingen site).

Exclusion Criteria

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality after treatment of femoropopliteal lesions with drug-coated balloon angioplasty and non-drug-coated balloon angioplasty/stent implantation

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