Mortality Risk Following Application of a Paclitaxel-Coated Stent in Femoropopliteal Lesions

Abstract

Purpose: To examine if endovascular therapy (EVT) with paclitaxel-coated stents increases the mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD). Materials and Methods: A retrospective analysis was conducted of paclitaxel-coated stent use in the femoropopliteal segment of 1535 symptomatic (Rutherford category 2 to 4) patients treated between January 2010 and December 2016 at 4 hospitals in Japan. The risk of all-cause mortality was examined between the 285 patients (mean age 73±8 years; 213 men) treated with a paclitaxel-coated stent (PTX-coated group) and 1250 patients (mean age 73±9 years; 872 men) not exposed to a paclitaxel-coated device (PTX-free group) during EVT. Propensity score matching was employed to balance baseline characteristics. Cox proportional hazards models stratified on the quintiles of the propensity score were used to investigate paclitaxel-coated stent use and mortality risk as well as interactions among baseline variables and the main outcome. Interactions between a PXT-coated stent and subgroups of the PTX-free group (bare stent and angioplasty) were also investigated, as was the impact of paclitaxel dose on mortality risk. The results of regression analysis are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 3-year overall survival estimates were 86.4% in the PTX-coated group vs 87.7% in the PTX-free group; the corresponding 5-year estimates were 77.5% vs 73.7%, respectively. There was no significant difference in all-cause mortality between the 2 groups (HR 0.89, 95% CI 0.66 to 1.19, p=0.41). The cause of death also showed no remarkable difference between the groups. Chronic renal failure (p=0.044) and arterial calcification (p=0.022) demonstrated a significant interaction effect on the association of the use of a PTX-coated stent with all-cause mortality. No subgroup demonstrated that the use of a paclitaxel-coated stent was associated with an increased risk of all-cause mortality. A dose dependency was not evident. Conclusion: Mortality risk following application of a PTX-coated stent did not increase over 5 years, irrespective of the dose. A PTX-coated stent for femoropopliteal lesions in PAD patients is a safe treatment option.

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices

“…The authors of the recent meta-analysis proposed a relationship between paclitaxel dose and excess mortality [12]. A retrospective study revealed that mortality risk following application of the DES did not increase over 5 years, irrespective of the paclitaxel dose [23]. Despite the very low dose and transient systemic and tissue levels of paclitaxel following DES implantation, a Cox model that included total paclitaxel dose received by the patient was performed.…”

Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Furthermore, several large real-world studies have been unable to replicate the same association between paclitaxel and mortality in PAD or the treatment of the dysfunctional arteriovenous fistula. [32][33][34][35][36][37][38][39] There is a great deal of ongoing work to determine whether the safety signal observed in patients with claudication represents a drug toxicity effect or a statistical association. However, the benefits of paclitaxel-coated devices are well established.…”

Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose “3D” Study

“…The drug dose, the drug formulation, the excipient, and the exposure time are still in debate. [30][31][32] Patient characteristics must also be taken into account. Manufacturers and others have performed independent patient data meta-analyses, 33 examined large populations, 34 and published pooled analyses.…”