# Amphilimus versus zotarolimus-eluting stent bij diabetes en coronairlijden

*geplaatst 2025-11-25 · Preventie · Heart (British Cardiac Society) · doi 10.1136/heartjnl-2025-325773 · https://hartvaat.nl/2025/11/25/amphilimus-versus-zotarolimus-eluting-stent-bij-diabetes-en-coronairlijden/*

Gerandomiseerde trial vergeleek amphilimus met zotarolimus-eluting stents bij diabetespatiënten. Beide platforms gaven vergelijkbare resultaten bij deze hoog-risicopopulatie.

## English: Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial.

The SUGAR trial compared amphilimus-eluting and zotarolimus-eluting stents in patients with diabetes mellitus undergoing PCI over extended follow-up. Both stent platforms demonstrated comparable target lesion failure rates in this high-risk population.

## Abstract (original, from the publication)

BACKGROUND: Patients with diabetes mellitus (DM) have an elevated risk of late events after percutaneous coronary intervention (PCI). The Second-generation Drug-eluting Stents in Diabetes (SUGAR) trial (NCT03321032) compared amphilimus-eluting stents (AESs) and onyx-zotarolimus-eluting stents (O-ZESs) in this population. OBJECTIVES: To report the co-primary endpoint comparing target lesion failure (TLF) between AES and O-ZES at 2 years and the extended follow-up at 3 years. METHODS: The SUGAR trial enrolled 1175 patients with DM across 23 centres in a randomised (1:1 AES (Cre8EVO) or O-ZES (Resolute Onyx)) assessor-blinded design. The primary endpoint, assessed with a Cox proportional hazards model, was TLF (a composite of cardiac death, target vessel myocardial infarction or ischaemia-driven target lesion revascularisation). Secondary endpoints included all-cause mortality, stent thrombosis and major adverse cardiac events. RESULTS: At 2 years, TLF occurred in 60 (10.4%) patients in the AES group and 71 (12.1%) in the O-ZES group; HR 0.84 (95% CI 0.60 to 1.19), p=0.331. At 3 years, TLF occurred in 66 (11.4%) of the AES group compared with 87 (14.9%) of the O-ZES group (HR 0.77; 95% CI 0.56 to 1.06; p=0.106). Landmark analysis revealed no significant differences in TLF rates between 1 and 3 years (HR 1.07; 95% CI 0.62 to 1.87; p=0.801). Rates of individual components of the primary endpoint were comparable between groups. No significant differences were observed in secondary endpoints. CONCLUSIONS: The SUGAR trial demonstrates that AES and O-ZES provide comparable long-term efficacy in preventing TLF in patients with DM undergoing PCI. These findings support the use of either stent type and highlight the importance of further long-term studies to optimise outcomes. TRIAL REGISTRATION NUMBER: NCT03321032.

Auteurs: Pablo Salinas, Rafael Romaguera, Josep Gómez-Lara, Salvatore Brugaletta, Antonio Gómez-Menchero, Pedro Martín, Miguel Romero, Sergio García-Blas, Marcelo Jiménez, Victor A Jiménez, Pascual Bordes, Jeremías Bayón, Neus Salvatella, Mar Alameda, Dae Hyun-Lee, Ramiro Trillo-Nouche, María López-Benito, Araceli Frutos, José Moreu, Bruno García Del Blanco, Mohsen Mohandes, Francisco Bosa Ojeda, Felipe Hernández Hernández, Eduardo Pinar-Bermúdez, Pilar Jiménez-Quevedo, Xavier Rosselló, Stuart Pocock, Manel Sabaté, Joan Antoni Gómez-Hospital, Josep Comin-Colet, Nieves Gonzalo, Antonio Fernández Ortiz

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Bron: Heart (British Cardiac Society), https://doi.org/10.1136/heartjnl-2025-325773. Bijgewerkt 2026-07-03T13:30:59Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.