Outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease

Kim, Tanner; Kiwan, Gathe; Mohamedali, Alaa; Zhang, Yawei; Mena‐Hurtado, Carlos; Mojibian, Hamid; Guzman, Raul J.; Chaar, Cassius Iyad Ochoa

doi:10.1016/j.jvs.2020.08.146

Cited by 4 publications

(2 citation statements)

References 18 publications

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“…8,9 On the contrary, recent meta-analyses, studies of large-scale registries and single-center experiences could not confirm this finding. [10][11][12][13][20][21][22][23] Although RCTs are considered the most scientifically rigorous clinical study design, patients included in prospective trials are highly selected, carry a different atherosclerotic profile and have a decreased comorbidity compared to real-world pragmatic cohorts. 22,24 Unlike RCTs, registries and insurance claim data provide information on a more generalizable group of patients and physician practices.…”

Section: Discussionmentioning

confidence: 99%

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease

et al. 2022

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Objectives The objective is to assess the performance of the Eluvia polymer coated drug eluting stent (DES) compared to a bare metal stent (BMS) platform in patients with femoropopliteal arterial disease. Methods This is a retrospective, single-center analysis. Patients treated with the Eluvia DES (group Eluvia) or the EverFlex BMS (group BMS) for femoropopliteal disease between January 2013 and December 2019 were included. Primary measure outcome of this analysis was the overall mortality. The PTX specific mortality, the primary patency, the amputation free survival (AFS), and the target lesion revascularization (TLR) rates were additionally evaluated. Results A total of 124 patients were treated by BMS deployment, while the Eluvia platform was preferred in 75 subjects. In both groups the majority presented with lifestyle limiting claudication (BMS: 84% vs Eluvia: 73%, p = 0.73). Chronic total occlusions were more frequent in patients treated by BMS (BMS: 71% vs Eluvia: 84%, p = 0.027), whereas the calcification burden (BMS: 81% vs Eluvia: 76%, p = 0.43) and the median lesion length (in mm, IQR) (BMS: 160 (100 to 240) vs Eluvia: 140 (80 to 229), p = 0.17) were comparable. At 24 months, the overall survival (BMS: 93% vs Eluvia: 89%, hazard ratio (HR): 1.20, 95% confidence interval (CI): 0.55 to 2.64, p = 0.64) and the PTX specific survival (BMS: 95% vs Eluvia: 95%, HR: 1.28, 95% CI: 0.41 to 4.02, p = 0.67) did not differ significantly between the two platforms. No significant difference was observed regarding the 24 months primary patency rate (BMS: 66% vs Eluvia: 78%, HR: 0.65, 95% CI: 0.37 to 1.15, p = 0.18), the freedom from TLR (BMS: 83% vs Eluvia: 89%, HR: 0.81, 95% CI: 0.39 to 1.68, p = 0.572), and the AFS (BMS: 93 vs Eluvia: 89%, HR: 1.20, 95% CI: 0.55 to 2.64). The Cox regression analysis revealed a higher mortality risk among patients with chronic limb-threatening ischemia (CLTI) (HR: 3.14, 95% CI: 1.61 to 6.14, p = 0.008), chronic obstructive pulmonary disease (COPD) (HR: 4.65, 95% CI: 2.14 to 10.09, p = 0.001), in octagenerians (HR: 4.40, 95% CI: 1.92 to 10.44, p = 0.005), and in patients not on statins at baseline (HR: 2.44, 95% CI: 1.19 to 4.99, p=0.014). Conclusions In this cohort, the use of the Eluvia DES did not increase the risk for mortality compared to BMS deployment. CLTI, COPD, advanced age, and the lack of statin therapy at baseline were associated with a higher risk for death.

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Section: Discussionmentioning

confidence: 99%

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease

et al. 2022

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“…The original review had been designed to evaluate patency rather than mortality; so, it is not possible to know if the groups were properly randomized regarding baseline mortality risk. 30 There is a lack of patient-level data, long-term data, accountability for crossover treatment arms, and many patients lost to follow-up which provides significant limitations on the data sets used. Therefore, even if it is argued that there is an increased all-cause mortality with paclitaxel exposure, there has not been any proof of a causal relationship between the two in the study of Katsanos et al 8 Multiple studies since have looked at the association between paclitaxel-coated devices and mortality; some studies have demonstrated no difference, while another has shown an absolute increased mortality risk of 4.6% without identification of a causal mechanism.…”

Section: Mortality Riskmentioning

confidence: 99%

Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind

Keefe,

Shull,

Botea

et al. 2023

Semin intervent Radiol

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Endovascular techniques for peripheral artery disease have changed significantly in the past 10 years with advances in technology and data. Treatment of superficial femoral disease is complex secondary to the length, degree of calcification, high rate of chronic total occlusion, and areas of flexion within this vessel. Use of drug-coated devices has increased the interventionalist's toolbox with the objective to improve freedom from target lesion revascularization and primary patency. There remains debate as to which devices may reach these goals while also limiting overall morbidity and mortality. This article aims to highlight recent advances in the literature regarding the use of drug-coated devices.

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High-Risk Characteristics for Clinical Failure after Isolated Femoropopliteal Peripheral Vascular Interventions

Kim¹,

Schneider²,

Iannuzzi³

et al. 2023

Annals of Vascular Surgery

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Outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease

Cited by 4 publications

References 18 publications

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease

Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind

High-Risk Characteristics for Clinical Failure after Isolated Femoropopliteal Peripheral Vascular Interventions

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