Dr Spaulding: Hello, I'm Christian Spaulding, I'm an interventional cardiologist working at the European Hospital Georges Pompidou University Paris Cité in Paris, France.

Radcliffe Cardiology: Can you briefly outline the design and rationale of the study?

Dr Spaulding: The rationale of the study is that drug eluting stents are used in the vast majority of PCIs with well-known immediate and midterm results. However, long-term studies have shown that there's an adverse event rate of 2% to 4% per year that is due to the presence of the stent in the artery causing very late stent thrombosis or formation of nueplex.
So therefore, a minimal stenting approach with drug coated balloons is desirable. The results that we have obtained up to now with paclitaxel eluting balloons has been mixed and sirolimus has been limited for the use on drug coated balloons because of technical problems.
The Selution SCB sirolimus eluting balloon is a new generation device that incorporates several new technologies that enable a 90 day delivery of the drug which is similar to what is seen with the Xlimus drug eluting stents and therefore the Selution DeNovo study was designed to assess the efficacy of the Selution sirolimus eluting balloon.
We randomize in an open label multicentre trial over 3,300 patients with wide inclusion exclusion criteria including patients with vessel sizes from two to five. Patients could be treated on several lesions.
We only excluded patients with STEMI or high-risk non-STEMI, chronic total occlusion instant restenosis or lesions on venous or arterial grafts. Patients were randomized to two groups, two strategies and this is important because randomization was done before the procedure and before vessel preparation.
The first group received sirolimus eluting balloon treatment with provisional stenting if needed and the second group was treated with systematic DES. Our primary endpoint at one year is target vessels failure.
A composite of target vessel related myocardial infarction, a clinically different target, vessel revascularization and cardiac death and this was assessed for non-inferiority at one year. We also will have a five year follow up where we will then again assess non inferiority and if non inferiority is met, we will assess for superiority.

Radcliffe Cardiology: What were the key one-year clinical outcomes of the two PCI strategies?

Dr Spaulding: At one year we reached non inferiority with 5.5% target vessel failure rate in the SEB strategy group, 4.5% in the DES strategy group and this difference is significant with a P value of 0.02.
Therefore, non-inferiority was met at one year. Stenting was used in approximately 20% of the patients in the SEB strategy group. And when we evaluated for subgroups, we noted an interaction in two subgroups.
Patients with high bleeding risk, where the interaction seemed in favor of the SEB group and patients with calcifications, moderate or severe calcifications where then again interactions seemed to be in favor of the SEB group.

Radcliffe Cardiology: What are the safety results?

Dr Spaulding: Of utmost importance, the safety endpoints were similar in both groups with very low rates of acute and sub-acute lesion thrombosis.

Radcliffe Cardiology: What is the take-home message for clinicians?
Dr Spaulding: Well, the take home message is that if you have a lesion that can be treated either by a sirolimus eluting balloon or by a DS and you have to choose, you want to choose between two strategies and you choose the SEB strategy.
This strategy is safe with a very low rate of lesion thrombosis, and you will end up with no stent in 80% of cases. This can be applied to a wide range of patients and a wide range of lesions in clinical practice.

Radcliffe Cardiology: What are the next steps?

Dr Spaulding: Follow up is ongoing for five years and we will reassess for non-inferiority at 5 years and if non inferiority is reached, we will test for superiority.