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