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Title: | Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimuseluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry | Authors: | Leistner, David M. Rampat, Rajiv Haude, Michael Schmitz, Thomas Allali, Abdelhakim Moellmann, Helge Staehli, Barbara E. Rudolph, Tanja K. Lauten, Alexander Koning, Rene BOGAERTS, Kris Sudhir, Krishnankutty Naber, Christoph |
Issue Date: | 2024 | Publisher: | EDIZIONI MINERVA MEDICA | Source: | Minerva Cardiology and Angiology, | Status: | Early view | Abstract: | BACKGROUND: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR. METHODS: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial. RESULTS: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and nonHBR patients (8.1% vs. 4.4%; P<0.001). All -cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the noninferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001). CONCLUSIONS: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all -comer population, including complex patients with HBR. | Notes: | Sudhir, K (corresponding author), Sahajanand Med Technol Ltd, Surat, India. krishna.sudhir@smtpl.com |
Keywords: | Hemorrhage;Drug-eluting stents;Dual anti-platelet therapy;Percutaneous coronary intervention;Sirolimus | Document URI: | http://hdl.handle.net/1942/43269 | ISSN: | 2724-5683 | e-ISSN: | 2724-5772 | DOI: | 10.23736/S2724-5683.24.06462-7 | ISI #: | 001234922700001 | Rights: | 2024 THE AUTHORS. This is an open access article distributed under the terms of the Creative Commons CC BY-NC license which allows users to distribute, remix, adapt and build upon the manuscript, as long as this is not done for commercial purposes, the user gives appropriate credits to the original author(s) and the source (with a link to the formal publication through the relevant DOI), provides a link to the license and indicates if changes were made. Full details on the CC BY-NC 4.0 are available at https://creativecommons.org/licenses/by-nc/4.0/. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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