Krystal Dinh1, Miguel Lemos Gomes2, Shannon D Thomas2,3,4, Sharath C V Paravastu5, Andrew Holden6, Peter A Schneider7, Ramon L Varcoe2,3,4. 1. Department of Vascular Surgery, Westmead Hospital, Sydney, NSW, Australia. 2. Department of Surgery, Prince of Wales Hospital, Sydney, NSW, Australia. 3. Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia. 4. The Vascular Institute, Prince of Wales Hospital, Sydney, NSW, Australia. 5. Department of Vascular Surgery, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK. 6. Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand. 7. Department of Vascular and Endovascular Surgery, University of California, San Francisco, CA, USA.
Abstract
PURPOSE: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). MATERIALS AND METHODS: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). RESULTS: The mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). CONCLUSION: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.
PURPOSE: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). MATERIALS AND METHODS: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). RESULTS: The mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). CONCLUSION: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.
Authors: Peter A Schneider; Marianne Brodmann; Laura Mauri; John Laird; Yoshimitsu Soga; Antonio Micari; Gary Ansel; Mehdi H Shishehbor; Prakash Krishnan; Qi Gao; Kenneth Ouriel; Thomas Zeller Journal: Catheter Cardiovasc Interv Date: 2020-08-24 Impact factor: 2.692