Abstracts from the current literature By Ripal T. Gandhi, MD, FSIR, and Suvranu Ganguli, MD, FSIR
This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at
gandhi@baptisthealth.net or
suvranu.ganguli@
bmc.org.
N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/ NEJMoa2005206.
Mortality with Paclitaxel-coated devices in peripheral artery disease
Joakim Nordanstig, Stefan James, Manne Andersson, Mattias Andersson, Peter Danielsson, Peter Gillgren, Martin Delle, Jan Engström, Torbjörn Fransson, Maher Hamoud, Anna Hilbertson, Patrik Johansson, Lars Karlsson, Björn Kragsterman, Hans Lindgren, Karin Ludwigs, Stefan Mellander, Niklas Nyman, Henrik Renlund, Birgitta Sigvant, Per Skoog, Joachim Starck, Gustaf Tegler, Asko Toivola, Maria Truedson , Carl-Magnus Wahlgren, Jonas Wallinder, Andreas Öjersjö, Mårten Falkenberg
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, 2,289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1,149 patients) or treatment with uncoated devices (the uncoated-device group, 1,140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1,480 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.)
J Vasc Surg. 2021 Jan;73(1):81-91. doi: 10.1016/j.jvs.2020.04.504.
Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair
Andrea Melloni, Alessandro Grandi, Sara Spelta, Simone Salvati, Diletta Loschi, Rosalba Lembo, Germano Melissano, Roberto Chiesa, Luca Bertoglio
Objective: The objective of this study was to evaluate the performance of percutaneous femoral access with large-bore sheaths (>21F outer diameter) mainly employed for thoracic and thoracoabdominal aortic endovascular treatment and to stratify the outcomes on the basis of the introducer size.
Methods: Between December 2015 and December 2018, all consecutive patients who received endovascular repair through a percutaneous approach with a suture-mediated vascular closure device (VCD) and the pre-close technique were included in a retrospective single-center study called Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO). The morphologic characteristics of the access vessels and patients' demographics were recorded, and 30-day closure success was defined as the primary end point. Analysis of the closure success comparing large-bore sheaths vs small-bore sheaths (21F outer diameter) was performed after 1:1 propensity score matching of preoperative confounding variables.
Results: The closure success rate of the entire study cohort was 94% (622 femoral accesses in 360 patients; median age, 74 years; 84% male). Univariate analysis identified eight different factors associated with failure, but only two remained significant on multivariate analysis: diabetes (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.2; P=.011) and common femoral artery stenosis >50% (OR, 4.5; 95% CI, 1.3- 13.7; P=.019). After propensity score matching (1:1, 172 femoral accesses per group), closure success rate was not significantly different between large-bore and small-bore sheaths (90.7% vs 93.0%; P=.43). Multivariate analysis of the large-sheath group identified two factors associated with failure: small (<9 mm) femoral arteries (OR, 6.9; 95% CI, 1.5-31.6; P=.13) and access vessel calcifications involving more than one-third
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