Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.
Joakim Nordanstig1, Stefan James1, Manne Andersson1
1From the Department of Molecular and Clinical Medicine, Institute of Medicine (J.N., P.S.) and the Department of Radiology, Institute of Clinical Sciences (K.L., M.F.), Sahlgrenska Academy, Gothenburg University, Gothenburg, the Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University (S.J., H.R.), and the Department of Surgical Sciences, Vascular Surgery, Uppsala University (B.K., B.S., G.T.), Uppsala, the Department of Clinical and Experimental Medicine, Linköping University, Linköping (Manne Andersson), Sweden and County Hospital Ryhov, Region Jönköping County, Department of Surgery, Jönköping (Manne Andersson), the Department of Vascular Surgery, Sunderby Hospital, Luleå (Mattias Andersson), the Department of Vascular Surgery, Halland Hospital, Halmstad (P.D.), the Department of Clinical Science and Education, Karolinska Institute (P.G.), the Departments of Surgery (P.G.) and Radiology (N.N.), Södersjukhuset, the Department of Radiology, Unit of Peripheral Interventional Radiology, Karolinska University Hospital (M.D., J.E.), and the Department. of Vascular Surgery, Karolinska University Hospital and the Karolinska Institute, (C.-M.W.), Stockholm, the Vascular Center, Department of Thoracic and Vascular Surgery, Skåne University Hospital, Malmö (T.F.), the Department of Vascular Surgery, Skaraborgs Hospital, Skövde (M.H.), the Department of Surgery, Kristianstad Hospital, Kristianstad (A.H.), the Department of Vascular Surgery, Växjö Hospital, Växjö (P.J.), the Department of Surgery, Gävle Hospital, Gävle (L.K.), the Department of Clinical Sciences, Faculty of Medicine (H.L.), Lund University (H.L., J.S.), Lund, the Vascular Unit, Department of Surgery, Helsingborg Hospital, Helsingborg (H.L.), the Section of Vascular Surgery, Surgical and Ear Clinic, Södra Älvsborg Hospital, Borås (K.L.), the Vascular Unit, the Department of Surgery, NU-Hospital Group, Trollhättan/Uddevalla (S.M.), the Department of Vascular Surgery, Karlstad Central Hospital, Karlstad (B.S.), the Department of Surgery, Västervik Hospital, Västervik (J.S.), the Department of Cardiothoracic and Vascular Surgery, Örebro University Hospital, Örebro (A.T.), the Department of Radiation Sciences, Radiology, Umeå University, Umeå (M.T.), the Department of Surgery, Sundsvall District Hospital, Sundsvall (J.W.), and the Department of Vascular Surgery, Kalmar Hospital, Kalmar (A.Ö.) - all in Sweden.
A study on paclitaxel-coated devices for peripheral artery disease found no increased death risk compared to uncoated devices. This interim analysis of a clinical trial offers reassurance regarding drug-coated technology safety in endovascular interventions.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Clinical Trials
Background:
- Concerns emerged from a meta-analysis regarding increased mortality risk with paclitaxel-coated angioplasty balloons and stents.
- These devices are used in lower-limb endovascular interventions for symptomatic peripheral artery disease (PAD).
Purpose of the Study:
- To investigate the association between drug-coated devices and all-cause mortality in PAD patients.
- To address safety concerns raised by previous meta-analyses regarding paclitaxel-coated devices.
Main Methods:
- An unplanned interim analysis of a multicenter, randomized, open-label, registry-based clinical trial was conducted.
- 2289 patients were randomized to receive either drug-coated (1149) or uncoated (1140) devices.
- Patients were stratified by disease severity: chronic limb-threatening ischemia or intermittent claudication. All-cause mortality was the primary endpoint.
Main Results:
- No significant difference in all-cause mortality was observed between the drug-coated and uncoated device groups over a mean follow-up of 2.49 years (25.5% vs. 24.6%).
- Mortality rates at 1 year were similar: 10.2% for drug-coated devices versus 9.9% for uncoated devices.
- No significant difference in death incidence was found between groups for patients with chronic limb-threatening ischemia or intermittent claudication.
Conclusions:
- This interim analysis of a randomized trial indicates no difference in all-cause mortality between paclitaxel-coated and uncoated endovascular devices for PAD.
- The findings do not support an increased risk of death associated with drug-coated devices in this patient population.
- Further follow-up is ongoing to confirm these results over a longer period.
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