Trial reportCardiovascular and interventional radiology2020
10-Year Paclitaxel Dose-Related Outcomes of Drug-Eluting Stents Treated Below the Knee in Patients with Chronic Limb-Threatening Ischemia (The PADI Trial).
Trial report in Cardiovascular and interventional radiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 29 citations in OpenAlex.
- Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.Vascular medicine (London, England) · 2023Trial
- The ups and downs of paclitaxel-coated balloons and paclitaxel eluting stents: do the conclusions of SWEDEPAD 2 change our practice? Should we be concerned about mortality (again)?CVIR endovascular · 2026Article
- Drug-eluting devices for lower limb peripheral arterial disease.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Review
- Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries.Journal of clinical medicine · 2024Review
- Surgical and Endovascular Therapies for Below-the-Knee Peripheral Arterial Disease: A Contemporary Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2024Review
- The Current Use of Drug-Eluting Balloons and Stents in Peripheral Arterial Disease: An Online Survey by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).Cardiovascular and interventional radiology · 2023Article
- Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries.World journal of clinical cases · 2023Article
- The Singa-Pacli Trial, Another RCT that Lacks to Encourage the use of DEB BTK.Cardiovascular and interventional radiology · 2021Article
- CVIR Editors' Medal 2021.Cardiovascular and interventional radiology · 2021Article
- Different Lower Extremity Arterial Calcification Patterns in Patients with Chronic Limb-Threatening Ischemia Compared with Asymptomatic Controls.Journal of personalized medicine · 2021Article
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRecently, two meta-analyses concluded that there appears to be an increased risk of long-term mortality of paclitaxel-coated balloons and stents in the superficial femoral and popliteal artery, and paclitaxel-coated balloons below the knee. In this post hoc study of the PADI Trial, we investigated the long-term safety of first-generation paclitaxel-coated drug-eluting stents (DES) below the knee and the dose-mortality relationships of paclitaxel in patients with chronic limb-threatening ischemia (CLI). MATERIALS AND
methodsThe PADI Trial compared paclitaxel-coated DES with percutaneous transluminal angioplasty with bail-out bare-metal stents (PTA ± BMS) in patients with CLI treated below the knee. Follow-up was extended to 10 years after the first inclusion, and survival analyses were performed. In addition, dose-related mortality and dose per patient weight-related mortality relations were examined.
resultsA total of 140 limbs in 137 patients were included in the PADI Trial. Ten years after the first inclusion, 109/137 (79.6%) patients had died. There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12). No specific dose-related mortality (HR 1.00, 95% CI 0.99-1.00, p = 0.99) or dose per weight mortality (HR 1.05, 95% CI 0.93-1.18, p = 0.46) relationships were identified in the Cox-proportional Hazard models or by Kaplan-Meier survival analyses.
conclusionsThere is a poor 10-year survival in both paclitaxel-coated DES and PTA ± BMS in patients with CLI treated below the knee. No dose-related adverse effects of paclitaxel-coated DES were observed in our study of patients with CLI treated below the knee. LEVEL OF EVIDENCE: The PADI Trial: level 1, randomized clinical trial.
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