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