PCR Issues Statement Supporting Continued Use of Paclitaxel-Based DCBs


May 21, 2019—PCR has issued a statement addressing the controversy on the use of paclitaxel drug-coated balloons (DCBs) in peripheral interventions. The statement concluded that 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, pending the availability of more definitive data. Alexandra Lansky, MD, presented the statement at EuroPCR 2019, held May 21–24 in Paris, France.

As noted in the PCR statement, this controversy was initially raised by the findings of a systematic review and meta‐analysis of randomized controlled trials evaluating paclitaxel‐coated balloons and stents in peripheral artery disease (PAD) that found an increased risk of death after application of these devices in this anatomy. That study was published online in December 2018 by Konstantinos Katsanos, MD, et al in Journal of the American Heart Association.

According to PCR, the Katsanos analysis—as for any meta-analysis—is subject to major inherent methodologic limitations that prevent reliable interpretation of the primary findings. These limitations include:

  • Use of study-level (rather than patient-level) data
  • Limited long-term data and high dropout rates (> 80% loss of patient data at 4–5 years)
  • Unknown repeated exposure to paclitaxel during reinterventions
  • Lack of adjudication of causes of death
  • Subsequent corrections to primary source data (announced in February 2019)

The PCR statement acknowledges that, although inconclusive, the meta-analysis findings have had the following positive effects:

  • They warranted further evaluation because of the widespread use of paclitaxel in peripheral interventions and the implications of the reported hazard.
  • They have served as a wake-up call and spurred 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.
  • They have instigated the upcoming FDA panel meeting in June when a planned industry-wide pooled analysis will be presented, with rapid dissemination of preliminary findings and planned next steps to the broader physician community; PCR noted that there is a vital need for this carefully conducted and adjudicated industry-wide patient-level pooled analysis that compares long-term safety outcomes.

However, PCR emphasized that:

  • Additional evidence from individual sponsor-driven patient-level 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.
  • No safety signal has ever been shown in coronary DCB applications in the long-term.
  • PCR strongly supports resuming the BASIL 3 and SWEDEPAD prospective randomized trials, which were suspended in response to the Katsanos et al publication; these trials would provide the vital evidence necessary to evaluate the safety of DCBs to better inform clinicians in everyday practice.

Endovascular Today's interview with the FDA's Center for Devices and Radiological Health representatives discussing the upcoming advisory panel meeting to review concerns and current data on paclitaxel-eluting device use is available here.

For all news related to the ongoing controversy regarding paclitaxel use in PAD, please visit Endovascular Today's comprehensive continuing coverage page.


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