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VRTD 2: Interview with Dr. Katsanos about the association between PTX-coated devices and overall mortality

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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.

Chapters

1. Introduction
0:00
2. Presentation of the paper
1:25
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?
11:51
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?
13:51
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
18:11
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
21:04
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
23:23
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
25:42
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?
27:27
10. Which is the pharmacological mechanism of PTX that could explain the increased mortality?
32:52
11. Association between PTX dosis and TLR or mortality
35:15
12. Wrap up and next steps
37:43