Joakim Nordanstig1, Stefan James1, Manne Andersson1, Mattias Andersson1, Peter Danielsson1, Peter Gillgren1, Martin Delle1, Jan Engström1, Torbjörn Fransson1, Maher Hamoud1, Anna Hilbertson1, Patrik Johansson1, Lars Karlsson1, Björn Kragsterman1, Hans Lindgren1, Karin Ludwigs1, Stefan Mellander1, Niklas Nyman1, Henrik Renlund1, Birgitta Sigvant1, Per Skoog1, Joachim Starck1, Gustaf Tegler1, Asko Toivola1, Maria Truedson1, Carl-Magnus Wahlgren1, Jonas Wallinder1, Andreas Öjersjö1, Mårten Falkenberg1. 1. From 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.
Abstract
BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).
RCT Entities:
BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patientsdied, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).
Authors: Ramya C Mosarla; Ehrin Armstrong; Yonatan Bitton-Faiwiszewski; Peter A Schneider; Eric A Secemsky Journal: J Soc Cardiovasc Angiogr Interv Date: 2022-08-20
Authors: Connor J S Moore; Kerry N L Avery; Amber Young; Robert J Hinchliffe; Xavier L Griffin; Shelley Potter Journal: Int J Surg Protoc Date: 2021-12-31