Paris, France, 21 May 2019. This PCR statement on paclitaxel drug-coated balloons (DCB) use in peripheral interventions addresses the controversy raised by the meta-analysis of K. Katsanos, MD, PhD (Patras University Hospital, Rion, Greece) and colleagues, published in late 2018. The Katsanos meta-analysis prompted widespread concern in the interventional community by suggesting that treatment with paclitaxel-eluting stents or DCBs for femoropopliteal disease is associated with increased
death beyond 1 year out to 5 years compared with uncoated balloon therapy.
The statement outlines that, as for any meta-analysis, the Katsanos analysis is subject to major inherent methodological limitations that prevent reliable interpretation of the primary findings. These include the use of study-level (rather than patient-level) data, limited longterm
data and high dropout rates (>80% loss of patient data at 4-5 years), unknown repeated exposure to paclitaxel during re-interventions, lack of adjudication of causes of death, and subsequent corrections to primary source data (announced in February 2019).
The Statement acknowledges that, while the results of the meta-analysis itself were far from conclusive, further evaluation is warranted given the widespread use of paclitaxel in peripheral interventions and the implications of the reported hazard. The publication did
serve as a wakeup call and swift action on the part of the interventional community, including industry and the FDA, to convene collaborative discussions, new analyses and presentations of patient level pooled data. A planned industry-wide pooled analysis is anticipated to be
presented at an upcoming FDA panel meeting in mid-June, with rapid dissemination of preliminary findings and planned next steps to the broader physician community.
The statement emphasises that additional evidence from individual sponsor-driven patientlevel analyses of clinical trial data, as well as large-scale claims data, have failed to replicate the results of the meta-analysis with respect to an association of paclitaxel exposure with
long-term mortality. Furthermore, no safety signal has ever been shown in coronary DCB applications in the long-term.
PCR acknowledges the vital need for a carefully conducted and adjudicated industry-wide patient level pooled analysis to compare long-term safety outcomes. This analysis is planned to be presented at the upcoming FDA panel on June 19th and 20th. Finally, PCR strongly
supports resuming, under careful safety oversight, two large prospective randomised trials (BASIL 3 and SWEDPAD) that were suspended shortly after the Katsanos publication. These trials would provide the vital evidence necessary to evaluate the safety of DCB to better inform clinicians in everyday practice.
Pending the availability of more conclusive data, there is currently no strong evidence to justify changing clinical practice and clinicians should continue to use best judgment in the use of paclitaxel-based DCBs.