VRTD 2: Association between PTX-coated devices and overall mortality
This is an exclusive interview with the first three authors (Dr. Katsanos, Dr. Spiliopoulos, Dr. Kitrou) of the paper entitled ‘Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials’ (J Am Heart Assoc. 2018 Dec 18;7(24):e011245). The authors answered relevant questions about the impact of their findings and the future of PTX-eluting devices.
VRTD 2: Interview with Dr. Katsanos about the association between PTX-coated devices and overall mortality
This is an exclusive interview with the first three authors (Dr. Katsanos, Dr. Spiliopoulos, Dr. Kitrou) of the paper entitled 'Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials' (J Am Heart Assoc. 2018 Dec 18;7(24):e011245). The authors answered relevant questions about the impact of their findings and the future of PTX-eluting devices.
2. Presentation of the paper
Dr. Katsanos provides a short presentation of the key findings of the paper.
3. Would you use now drug-coated technologies in your daily practice?
After the publication of this paper, there was a big reaction among the physicians and the industry. Dr. Katsanos, the big question that was raised was if we should stop using drug-eluting technologies until we have more data. What is your recommendation?
4. Which were the causes of death in these patients?
Dr. Spiliopoulos your meta-analysis showed a correlation between PTX-coated device use and mortality. However, this does not mean PTX causes mortality. Any cause-effect relationship needs to be proven with patient-level data. Since independent Clinical Event committees with access to patient-level d
5. Mortality in SFA trials with BMS, covered stents and sirolimus-coated stents
Dr. Kitrou, when we look at SFA trials with BMS, Covered Stents, Sirolimus stents (ie, non-PTX coated) we observe a higher trend of mortality Vs their respective control arms. How do you take this into account in your paper’s conclusion that PTX-coated device causes mortality?
6. RCTs versus real-world data
A recent analysis presented by Jones at TCT, looking at more than 82000 CMS records highlighted statistically significant lower mortality of DCB Vs non-DCB patients at 1 year. This suggests a different trend compared to your meta-analysis. Are there any potential bias introduced by RCTs?
7. Key opinion leaders and industry’s own patient-level analysis
Your paper has generated a lot of attention as well as controversies. Many key opinion leaders disagreed with your conclusion. Some companies have also conducted their own patient-level analysis with thousands of patients and did not see the increase in mortality rate. What are we missing here?
8. Patients' recruitment in DCB and DES trials
Dr. Katsanos, several big independent trials stopped the recruitment of the patients until this issue is clarified. Can you comment on this and what should be done to have a clear answer to this question?
9. Could the reintervention have a protective effect for survival?
10. Which is the pharmacological mechanism of PTX that could explain the increased mortality?
11. Association between PTX dosis and TLR or mortality
12. Wrap up and next steps
Thanks for sharing! Very interesting! I think that open peripheral surgery is still alive and we must expect an increase of open procedures over the years. Maybe…
Agree. Although, for claudication patients the first treatment should always be conservative.
Very interesting paper. However, if their findings are confirmed in other studies, I think it might have any impact on the PTX-devices use rather than reducing the number of endovascular procedures. Nowadays, the increasing age, number of comorbidities of patients we have to deal with, make an open approach unthinkable.
I am not a statistician. But the statement “the two group are identical” is wrong. The groups may be comparable. Randomization was for sure not done for life expectancy, but for lesion characteristics. We need the opinion of a statistician. The study was not accepted for publication in “high ranked” Journals. Why?
Additionally, the comparison of many studies at the beginning and of a few studies at 2 and 5 years looks “strange” in my opinion.
The studies were externally controlled by Independent committees. What is the reason why they did not find safety issues? It is a pity that these points were not addressed during the round table.
RCTs were included only in the meta-analysis. The paclitaxel arms and the control arms had similar-comparable baseline demographics without any significant differences (please refer to Appendix of the paper in JAHA). Not all studies had the same periods of follow-up time. Hence, the different number of studies for each time point. Our raw data is available ‘open access’ in the paper for any body to double-check. Independent reviews are of course more than welcome.
Greetings, thanks for sharing your research.
The authors are reporting that mortality paclitaxel- related is dependent on the dose loaded on the device. Do the authors think that mortality paclitaxel-related after 1 year could depend whether on the paclitaxel load transferred to vessel wall or the load lost in the bloodstream during the delivering of the device. If this could be related to the load of paclitaxel lost during the delivering it shuld urge the developement of better drug bonding to the device.