Most-watched scientific paper presentation

The abstract you submitted for CIRSE 2024 “Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery. The SIRONA randomized controlled trial” has been the congress’ most-viewed scientific paper presentation. What do you think makes it so relevant?

Teichgräber: Paclitaxel represents the standard drug for drug-coated balloon (DCB) angioplasty in PAD treatment due to its superiority in patency rates as compared to non-coated old balloon angioplasty (POBA). Safety is still conflicting for paclitaxel DCBs due to long-term all-cause mortality signals, increased lower limb amputation rates and vessel wall damage with inadvertent aneurymatic dilatation. Loss of confidence among patients and physicians in paclitaxel DCB leads to the question of whether sirolimus DCB is a viable alternative.

The SIRONA head-to-head randomized trial represents the first comparison of the novel concept of sirolimus-DCB angioplasty with the state-of-the-art treatment of paclitaxel-DCB in the femoropopliteal artery for peripheral arterial disease (PAD) in claudicants. Sirona is also one of the largest multicentre studies, which included 482 patients in a 1:1 randomization in 28 recruiting vascular centres in Germany and Austria. Another important aspect of the SIRONA study is that it is being carried out as an investigator initiative study (IIT) under the sponsorship of the Friedrich Schiller University Jena in Germany. Such IIT provides more trustworthy results and is therefore more interesting to the medical community as industry-sponsored trials.

Will you continue to research this topic? What’s next?

Teichgräber: The SIRONA study has a follow-up period of 5 years. I presented the preliminary one-year results at CIRSE 2024. I will therefore probably present the 2-year results or further subgroup and post-hoc analyses at the First@CIRSE session at CIRSE 2025. I also lead the sister clinical trial LIMES. Again, as an IIT with a total of 30 recruiting centres in Germany and Austria. LIMES deals with the use of sirolimus DCB in below-the-knee revascularization in critical limb threatening ischemia (CLTI) compared to uncoated POBA angioplasty. This is also a highly exciting trial that has the potential to be a game changer. However, this study is still recruiting, so I probably won’t be able to show any results at CIRSE 2025 yet.

What feedback have you personally received on your presentation, during the congress and since?

Teichgräber: The response was overwhelming for me. American and Asian colleagues in particular were very interested in the first insights into the SIRONA trial. The primary endpoint, which was not yet available at CIRSE 2025 because the Clinical Event Committee had not yet carried out its independent evaluation, was then presented at the TCT conference in Washington DC eight weeks later as a late-breaking clinical trial in collaboration with The Lancet and was considered as one of the most important clinical studies in 2024 for the field of cardiovascular interventions.

Do you have any tips for young physicians on what to watch out for when submitting a scientific abstract?

Teichgräber: My most important advice for planning and conducting a clinical study, regardless of whether it is a multicentre or monocentre study, a randomized or just a small single-arm observational study, is to consider the development of a dedicated study protocol in advance. This requires a lot of time, motivation and support, ideally from a university study centre.

Are you planning to submit another abstract for CIRSE 2025 and if so, can you share what it will be about?

Teichgräber: For sure, I hope that I will be able to present the 2-year results from the SIRONA trial. This is particularly exciting to show that non-inferiority is sustainable or even superior in terms of freedom from target lesion revasculization (FfTLR). Post-hoc or subgroup analyses are also of particular interest. I will definitely submit one of the two abstracts for First@CIRSE. Let’s see …