Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry.
| Autor: | Leistner DM; Department of Cardiology, Angiology and Intensive Care Medicine, Goethe University Hospital, Frankfurt, Germany.; DZHK (German Center for Cardiovascular Research), partner site Rhein-Main, Frankfurt, Germany., Rampat R; Cardiovascular European Research Center, Massy, France., Haude M; Rheinland Klinikum Neuss GmbH, Neuss, Germany., Schmitz T; Elisabeth-Krankenhaus Essen, Essen, Germany., Allali A; Heart Center Segeberger Kliniken GmbH, Bad Segeberg, Germany.; University Heart Center Lübeck, Medical Clinic II, Lübeck, Germany., Möllmann H; St Johannes Hospital Dortmund, Dortmund, Germany., Stähli BE; Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland., Rudolph TK; Clinic for General and Interventional Cardiology, Heart and Diabetes Center Northrhine Westfalia, Bad Oeynhausen, Germany., Lauten A; HELIOS Klinikum Erfurt, Erfurt, Germany., Koning R; Saint Hilaire Clinic, Rouen, France., Bogaerts K; KU Leuven, I-BioStat, Leuven, Belgium.; UHasselt, I-BioStat, Diepenbeek, Belgium., Sudhir K; Sahajanand Medical Technologies Limited, Surat, India - krishna.sudhir@smtpl.com., Naber C; Facharztpraxis Baldeney, Essen, Germany. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | Minerva cardiology and angiology [Minerva Cardiol Angiol] 2024 Aug; Vol. 72 (4), pp. 355-365. Date of Electronic Publication: 2024 May 27. |
| DOI: | 10.23736/S2724-5683.24.06462-7 |
| Abstrakt: | 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 non-HBR 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 non-inferiority 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. |
| Databáze: | MEDLINE |
| Externí odkaz: |
|