Meta-Analysis Shows Heterogeneity in Benefits and Risks With Paclitaxel-Coated Balloons
October 21, 2019—Jena University Hospital in Jena, Germany, announced the publication of findings from a meta-analysis conducted by the institution that sought to evaluate benefits and risks of paclitaxel-coated balloon angioplasty compared with plain old balloon angioplasty as therapy for intermittent claudication in femoropopliteal artery disease. Christof Klumb, MD, et al, published the study online in EClinicalMedicine, a publication of The Lancet.
According to Jena University Hospital, the study confirms an increased rate of all-cause mortality, which previously has been seen, and found a broad heterogeneity in the effectiveness of the procedure depending on predilation strategy, lesion complexity, and paclitaxel density. The investigators raise doubts about a class effect of drug-coated balloons (DCBs) and suggest highly individualized therapeutic decision-making.
Recounting the background of the meta-analysis, the announcement noted that for intermittent claudication, DCB angioplasty is the therapy of choice to reduce the risk of target lesion restenosis, and consequently, the necessity of reintervention. However, numerous types of these balloons are distinguished by drug density and coating. Also, clinical efficacy is not proven for all types. Moreover, conflicting evidence exists about the risk of mortality that arose from the meta-analysis published in December 2018 by Konstantinos Katsanos, MD, et al in Journal of the American Heart Association.
The announcement stated that the current meta-analysis sought to evaluate the benefit and risk of DCB angioplasty compared with noncoated balloon angioplasty by assessing the main outcomes of freedom from target lesion revascularization and all-cause mortality.
The investigators evaluated 14 randomized trials comparing both procedures for the treatment of femoropopliteal artery disease. The trials were composed of a total of 2,504 patients and were conducted between 2005 and 2019. The risk of all-cause mortality at 2 years was found to significantly increase with a trend toward a paclitaxel dose-response relationship but without evidence of causation. DCB angioplasty also significantly increased the risk of target lesion restenosis.
However, results showed substantial heterogeneity caused by substantial interstudy design differences, interstudy lesion complexity differences, and interstudy device differences. There is a risk of overestimation of the benefit because of the high risk of bias within studies, mainly driven by missing blinding of study personnel. Head-to-head comparisons of different coated balloons under the same conditions will be needed to evaluate different product efficacy. Additional pharmacological studies are needed to generate robust and meaningful evidence on safety or risk of intravessel paclitaxel application, concluded the investigators.
Professor Ulf Teichgräber, MD, who is Director of the Jena University Hospital's Department of Radiology and the corresponding author of this meta-analysis, commented in the hospital’s announcement, “There are first trials that are already beginning to examine if sirolimus-coated balloons could be an alternative to paclitaxel-coated ones. Also, newer coating technologies of paclitaxel balloons seem to have less drug loss during the procedure and better drug release to the target lesion. Innovation in this field clearly is leading towards better efficacy and safety.”