Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality

Dan, Kazuhiro; Shlofmitz, Evan; Khalid, Nauman; Hideo‐Kajita, Alexandre; Wermers, Jason P.; Torguson, Rebecca; Kolm, Paul; Waksman, Ron

doi:10.1016/j.ahj.2019.12.012

Cited by 21 publications

(10 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Interpretation of trials with operational flaws can similarly be difficult. A meta-analysis of RCTs of paclitaxel-coated balloons for the treatment of peripheral artery disease showed increased mortality, but incomplete follow-up in the component trials and informative censoring has led some to question the results ( 90 , 91 ). The ATLAS 2-ACS (Anti Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndromes) RCT, which showed that adding low-dose rivaroxaban to standard therapy after acute coronary syndrome reduced the incidence of ischemic events, did not lead to regulatory approval of low-dose rivaroxaban in the United States, partly due to questions about missing data and unknown vital status ( 92 , 93 ).…”

Section: The Path Forward: Bringing Randomization To the Real Worldmentioning

confidence: 99%

Randomized Trials Versus Common Sense and Clinical Observation

Fanaroff

Califf

Harrington

et al. 2020

Journal of the American College of Cardiology

View full text Add to dashboard Cite

Concerns about the external validity of traditional randomized clinical trials (RCTs), together with the widespread availability of real-world data and advanced data analytic tools, have led to claims that common sense and clinical observation, rather than RCTs, should be the preferred method to generate evidence to support clinical decision-making. However, over the past 4 decades, results from well-done RCTs have repeatedly contradicted practices supported by common sense and clinical observation. Common sense and clinical observation fail for several reasons: incomplete understanding of pathophysiology, biases and unmeasured confounding in observational research, and failure to understand risks and benefits of treatments within complex systems. Concerns about traditional RCT models are legitimate, but randomization remains a critical tool to understand the causal relationship between treatments and outcomes. Instead, development and promulgation of tools to apply randomization to real-world data are needed to build the best evidence base in cardiovascular medicine.

show abstract

Section: The Path Forward: Bringing Randomization To the Real Worldmentioning

confidence: 99%

Randomized Trials Versus Common Sense and Clinical Observation

Fanaroff

Califf

Harrington

et al. 2020

Journal of the American College of Cardiology

View full text Add to dashboard Cite

show abstract

“…3,4 Recently several groups showed that paclitaxel-coated balloons and stents in the femoropopliteal artery may be associated with increased risk of death, although this conclusion is controversial. 3,5 Since neointimal hyperplasia remains a significant obstacle after vascular interventions, novel treatment methods need to be explored.…”

mentioning

confidence: 99%

Inhibition of programmed death‐1 decreases neointimal hyperplasia after patch angioplasty

Bai

Wang

et al. 2020

J Biomed Mater Res

View full text Add to dashboard Cite

Neointimal hyperplasia remains an obstacle after vascular interventions. Programmed death-1 (PD-1) antibody treatment decreases tumor cell proliferation and secretion of inflammatory factors, and several antineoplastic drugs show efficacy against neointimal hyperplasia. We hypothesized that inhibition of PD-1 inhibits neointimal hyperplasia in a rat patch angioplasty model. In a rat aorta patch angioplasty model, four groups were compared: the control group without treatment, a single dose of humanized PD-1 antibody (4 mg/kg) injected immediately after patch angioplasty, PD-1 antibody-coated patches, and BMS-1 (PD-1 inhibitor)-coated patches. Patches were harvested (Day 14) and analyzed. After patch angioplasty, PD-1-positive cells were present. Inhibition of PD-1 using both intraperitoneal injection of humanized PD1 antibody as well as using patches coated with humanized PD1 antibody significantly decreased neointimal thickness (p = 0.0199). There were significantly fewer PD-1 (p = 0.0148), CD3 (p = 0.0072), CD68 (p = 0.0001), CD45 (p = 0.001), and PCNA (p < 0.0001)-positive cells, and PCNA/α-actin dual positive cells (p = 0.0005), in the treated groups. Patches coated with BMS-1 showed similarly decreased neointimal thickness and accumulation of inflammatory cells. Inhibition of PD-1 using PD-1 antibody or its inhibitor BMS-1 can significantly decrease neointimal thickness in vascular patches. Inhibition of the PD-1 pathway may be a promising therapeutic strategy to inhibit neointimal hyperplasia.

show abstract

“…However, two additional studies from the FDA and the VIVA physicians also reported a higher risk for death after the application of PTX. 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.…”

Section: Discussionmentioning

confidence: 87%

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

et al. 2022

View full text Add to dashboard Cite

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.

show abstract

Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality

Cited by 21 publications

References 36 publications

Randomized Trials Versus Common Sense and Clinical Observation

Randomized Trials Versus Common Sense and Clinical Observation

Inhibition of programmed death‐1 decreases neointimal hyperplasia after patch angioplasty

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

Contact Info

Product

Resources

About