Interventions with paclitaxel drug-coated balloons

May 21, 2019

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.
-end-
NOTES TO EDITORS

Key information
About EuroPCR 2019 The World-Leading Course in interventional cardiovascular medicine and the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) will take place from 21 to 24 May 2019 at the Palais des Congres - Paris, France. The detailed Course Programme is available on: https://www.pcronline.com/Courses/EuroPCR

About PCR

The mission of PCR is to serve the needs of each individual patient by helping the cardiovascular community to share knowledge, experience and practice. PCR offers a large range of many other educational meetings and resources for the continuing education of the interventional cardiovascular community. These include major annual Courses across the globe, e-Learning with high-profile PCR Webinars, Courses specifically dedicated to valvular heart disease, tailormade PCR Seminars on specific topics, online resources and medical publications such as EuroIntervention, the official journal of the EAPCI.

Gateways to all PCR activities are available on http://www.pcronline.com

For further information, please contact Celia Vila: cvila@europa-group.com

HELP FOR JOURNALISTS TO COVER EUROPCR 2019

Register and attend EuroPCR 2019 as a journalist


Open to accredited journalists, free of charge. Journalists must hold a valid press card and/or provide a letter of assignment from a recognised publication. To register as press go to https://www.pcronline.com/Courses/EuroPCR/Press

EuroPCR press releases can be found at https://www.pcronline.com/News/PCR-Press-Releases

For the press briefing schedule check https://www.pcronline.com/Courses/EuroPCR/Press

For any press-related enquiries, please contact EuroPCR Press Coordinator, Isabelle Uzielli: iuzielli@europcr.com

PCR

Related Data Articles from Brightsurf:

Keep the data coming
A continuous data supply ensures data-intensive simulations can run at maximum speed.

Astronomers are bulging with data
For the first time, over 250 million stars in our galaxy's bulge have been surveyed in near-ultraviolet, optical, and near-infrared light, opening the door for astronomers to reexamine key questions about the Milky Way's formation and history.

Novel method for measuring spatial dependencies turns less data into more data
Researcher makes 'little data' act big through, the application of mathematical techniques normally used for time-series, to spatial processes.

Ups and downs in COVID-19 data may be caused by data reporting practices
As data accumulates on COVID-19 cases and deaths, researchers have observed patterns of peaks and valleys that repeat on a near-weekly basis.

Data centers use less energy than you think
Using the most detailed model to date of global data center energy use, researchers found that massive efficiency gains by data centers have kept energy use roughly flat over the past decade.

Storing data in music
Researchers at ETH Zurich have developed a technique for embedding data in music and transmitting it to a smartphone.

Life data economics: calling for new models to assess the value of human data
After the collapse of the blockchain bubble a number of research organisations are developing platforms to enable individual ownership of life data and establish the data valuation and pricing models.

Geoscience data group urges all scientific disciplines to make data open and accessible
Institutions, science funders, data repositories, publishers, researchers and scientific societies from all scientific disciplines must work together to ensure all scientific data are easy to find, access and use, according to a new commentary in Nature by members of the Enabling FAIR Data Steering Committee.

Democratizing data science
MIT researchers are hoping to advance the democratization of data science with a new tool for nonstatisticians that automatically generates models for analyzing raw data.

Getting the most out of atmospheric data analysis
An international team including researchers from Kanazawa University used a new approach to analyze an atmospheric data set spanning 18 years for the investigation of new-particle formation.

Read More: Data News and Data Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.