Objectives: To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice.
Background: A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices.
Methods: Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who underwent DES angioplasty or uncoated balloon or stent angioplasty of femoropopliteal lesions with a follow-up of 3-7 years.
Results: 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.
Conclusion: In real world, long-term mortality rate was lower after DES angioplasty than after treatment with uncoated devices. Mortality predictors were co-morbidities, risk factors, and disease severity.
Keywords: angioplasty; drug-eluting stent; femoropopliteal artery; mortality; paclitaxel.
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