Evaluation of mortality following paclitaxel drug-coated stent angioplasty of femoropopliteal lesions in real world.

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.

Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World.

OBJECTIVES: This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice. BACKGROUND: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices. 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, 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 = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 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 = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007). CONCLUSIONS: In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.