Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene – a single center experience
Abstract
Summary:Background: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. Patients and methods: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. Results: Overall 624 patients with femoropopliteal lesions were included in this study. Of those, 197 patients were treated with POBA without crossover to a paclitaxel coated device during follow-up and 427 patients with DCB angioplasty. Mean follow-up time was 33.3 ± 25.4 months. Mortality incidence was 81.7% (95% confidence interval [95% CI]: 76.1–86.8) after POBA and 59.0% (95% CI: 54.6–63.9) after DCB (p < 0.001). Multivariate logistic regression analysis revealed type of treatment (POBA vs. DCB, (hazard ratio [HR]: 0.332, 95% CI: 0.215–0.514, p < 0.001), age per year (HR: 1.065, 95% CI: 1.046–1.087, p < 0.001), coronary heart disease (HR: 1.969, 95% CI: 1.323–2.930, p = 0.001), renal insufficiency (HR: 1.583, 95% CI: 1.079–2.323, p = 0.019), stroke (HR: 2.505, 95% CI: 1.431–4.384, p = 0.001) as predictors for all-cause mortality. In the subgroup excluding octogenarians, mortality predictors were type of treatment (HR: 0.463, 95% CI: 0.269–0.796, p = 0.005), age per year (HR: 1.035, 95% CI: 1.002–1.069, p = 0.038), coronary heart disease (HR: 2.082, 95% CI: 1.274–3.400, p = 0.003), stroke (HR: 2.203, 95% CI: 1.156–4.197, p = 0.016) and renal insufficiency (HR: 2.201, 95% CI: 1.357–3.571, p < 0.001). Conclusions: This monocentric retrospective analysis showed no survival disadvantage for patients in Rutherford-Becker stage 5 after treatment with paclitaxel-coated balloons.
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