- My name is professor David Leistner, I'm head of the interventional cardiology, at Charité Universitätsmedizin, Berlin in Germany. And I presented at the EuroPCR 2022, the primary results of the CRUZ-HBR study.
Aim of This Study
So, the aim of the study was to assess the performance of the ultra thin strut Supraflux Cruz Stent in a large broad cohort of all-comer patients with a certain number, of about one third, high bleeding risk HBR patients.
The Supraflux Cruz Stent
So we investigated the Supraflux Cruz drug-eluting stent, which is a ultra thin strut stent, drug-eluting stent, with strut thickness of about 60 micrometres, independent of the size of the stent, and it has a bioresorbable polymer which allows very fast healing of this stent device.
So what we see, that in this all-comer population we see a favourable clinical outcome after PCI using the novel ultra thin Supraflux-Cruz drug-eluting stent. This was non-inferior to the TALENT study, the randomised study, which leads to the use of the Supraflux drug-eluting stent in clinical practice, and for the HBR subgroup of patients within the study, we could show that the Supraflux-Cruz stent was non-inferior for the outcome with the endpoint Doche device orientated clinical outcome in HBR patients.
Take-Home Messages for Practicing Clinicians
So what we see now is where that we have device specific evidence for the use in the broad spectrum of all-comer patients for non-HBR, as well as for HBR patients, to use this novel generation of ultra thin Supraflux-Cruz drug-eluting stent, And for my personal opinion, this is important for every new device to investigate such a device in the highest risk patients we treat every day in the cath lab, and these are HBR patients.
Further Study Needed and Next Steps
As we see in CRUZ-HBR now, the cruz stent seems to be a perfect solution for patient with high bleeding risk and very complex lesions. So the next step would be that on the one hand, you have to challenge this stent in only special situations, For example, CTOs, bifurcations, where this dedicated novel stent can optimise the results, and on the other hand I think this stent opens the possibility to think again about, and minimising the dual antiplatelet therapy, maybe if you use such ultra thin strut stent, it could be enough to treat it after a very clear implantation procedure to treat the patients only with one anti-thrombotic medication, but I think for this unique randomised prospective clinical trials, and I think they are actually in the face of plane.