Physician Views: What impact have Katsanos et al's meta-analysis findings had on prescribing trends for paclitaxel-coated devices?

It’s been a couple of months since the Journal of the American Heart Association published findings from a meta-analysis by Dr Konstantinos Katsanos, of the Patras University Hospital in Greece, and his colleagues, that suggested there was an increased long-term risk of death after paclitaxel-coated balloons of stents were used to treat lesions in the femoral or popliteal artery.


The meta-analysis looked at 28 randomised controlled trials of different paclitaxel-coated balloons and stents, some of which are current brand leaders in the endovascular device market, including Medtronic’s IN.PACT and Cook Medical’s Zilver, among others.


Subsequently, investigators of two paclitaxel trials - BASIL-3 and SWEDEPAD - have suspended patient recruitment whilst they review the data collected so far and re-examine study protocols. Additionally, the US FDA issued a notice last month to say it is doing its own evaluation of the long-term safety data of these devices to clarify the magnitude of the risk. However, in its recommendations to physicians, the agency did not explicitly advise against the prescribing of paclitaxel balloon or stent therapies.


We are snap-polling cardiovascular specialists to assess whether Katsanos et al’s meta-analysis has had any impact so far on clinical practice and the level of concern within the physician community.


Our questions are as follows:


Q1. In 2018, around what percentage of your peripheral arterial disease (PAD) patients were you treating with paclitaxel-eluting stents or paclitaxel-coated balloons?  




Q2. Which do you prescribe more to your PAD patients: paclitaxel-coated balloons or stents or both equally?




Q3. On Dec 6, 2018, the Journal of American Heart Association published a paper by Katsanos et al, in which the researchers conducted a meta-analysis of 28 randomised controlled trials of paclitaxel-coated balloons and stents and found a significant increase in mortality risk in patients treated with these devices, after two years (7.2 percent for paclitaxel group versus 3.8 percent for non-paclitaxel); and at three years, the risk increased even more (14.7 percent for paclitaxel versus 8.1 percent for non-paclitaxel).


On a scale of 1 to 5 (1= not concerned at all,  5 = extremely concerned), could you please rate your level of concern about the findings from the JAHA paper.




Q4. The FDA also put out a notice on January 17, 2019, to say it is conducting its own evaluation of long-term data on these devices and doing additional statistical analyses to clarify the presence and magnitude of any long-term risks. But there have not been any formal notice issued recommending physicians to stop prescribing paclitaxel-coated devices to PAD patients.


Since the JAHA paper and the FDA notice, how have the prescription levels of paclitaxel-coated devices been impacted in your practice?




Q5. Which brand of paclitaxel-coated balloons and stents have you been using the most frequently in your practice?



Results and related analysis will shortly be published for FirstWord MedTech PLUS subscribers to read, with the opportunity for non-FirstWord MedTech PLUS subscribers to purchase these findings. If you want to be notified when the poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact

Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls.  However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.

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