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临床试验/DRKS00019039
DRKS00019039已完成不适用

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

niversitäts-Herzzentrum Bad Krozingen0 个研究点目标入组 1,500 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,500

研究概览

简要总结

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).

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 105 Years(—)
性别
All

入选标准

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

排除标准

  • - 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

研究者

发起方
niversitäts-Herzzentrum Bad Krozingen

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