{
  "abstract": "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",
  "authors": [
    {
      "affiliations": [
        "Interventional Cardiology, Hospital Clínico San Carlos, Madrid, Spain",
        "Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid Madrid"
      ],
      "name": "Pablo Salinas"
    },
    {
      "affiliations": [
        "Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Spain"
      ],
      "name": "Rafael Romaguera"
    },
    {
      "affiliations": [
        "Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Spain"
      ],
      "name": "Josep Gómez-Lara"
    },
    {
      "affiliations": [
        "Cardiovascular Institute Hospital Clinic, Barcelona, Spain"
      ],
      "name": "Salvatore Brugaletta"
    },
    {
      "affiliations": [
        "Hospital Juan Ramón Jiménez, Huelva, Spain"
      ],
      "name": "Antonio Gómez-Menchero"
    },
    {
      "affiliations": [
        "Cardiology, Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain"
      ],
      "name": "Pedro Martín"
    },
    {
      "affiliations": [
        "Cardiology, Reina Sofia University Hospital, Córdoba, Spain"
      ],
      "name": "Miguel Romero"
    },
    {
      "affiliations": [
        "Department of Cardiology, Hospital Clínico Universitario de Valencia, Valencia, Spain",
        "Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain"
      ],
      "name": "Sergio García-Blas"
    },
    {
      "affiliations": [
        "Interventional Cardiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain"
      ],
      "name": "Marcelo Jiménez"
    },
    {
      "affiliations": [
        "Hospital Álvaro Cunqueiro, Vigo, Spain"
      ],
      "name": "Victor A Jiménez"
    },
    {
      "affiliations": [
        "Hospital General Universitario de Alicante, Alicante, Spain"
      ],
      "name": "Pascual Bordes"
    },
    {
      "affiliations": [
        "Hospital Lucus Augusti, Lugo, Spain"
      ],
      "name": "Jeremías Bayón"
    },
    {
      "affiliations": [
        "Interventional Cardiology, Hospital del Mar, Barcelona, Spain"
      ],
      "name": "Neus Salvatella"
    },
    {
      "affiliations": [
        "Hospital Universitario Son Espases. Institut d'Investigació Sanitària Illes Balears, Palma, Spain"
      ],
      "name": "Mar Alameda"
    },
    {
      "affiliations": [
        "Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain"
      ],
      "name": "Dae Hyun-Lee"
    },
    {
      "affiliations": [
        "Cardiology, Hospital Universitario Santiago de Compostela, Coruña, Spain"
      ],
      "name": "Ramiro Trillo-Nouche"
    },
    {
      "affiliations": [
        "Hospital Universitario de León, Leon, Spain"
      ],
      "name": "María López-Benito"
    },
    {
      "affiliations": [
        "Unidad de Hemodinámica. Sección de Cardiología, Hospital Universitario San Juan de Alicante, Alicante, Spain"
      ],
      "name": "Araceli Frutos"
    },
    {
      "affiliations": [
        "Hospital Virgen de la Salud, Toledo, CM, Spain"
      ],
      "name": "José Moreu"
    },
    {
      "affiliations": [
        "Cardiology, Vall d’Hebron University Hospital, Barcelona, Spain"
      ],
      "name": "Bruno García del Blanco"
    },
    {
      "affiliations": [
        "Cardiology, Hospital Joan XXIII, Tarragona, Tarragona, Spain"
      ],
      "name": "Mohsen Mohandes"
    },
    {
      "affiliations": [
        "Cardiology, Hospital Universitario de Canarias, La Laguna, Tenerife, Spain"
      ],
      "name": "Francisco Bosa Ojeda"
    },
    {
      "affiliations": [
        "Hospital Universitario La Luz, Madrid, Spain"
      ],
      "name": "Felipe Hernández Hernández"
    },
    {
      "affiliations": [
        "Cardiology Department, Hospital Universitario Virgen de la Arrixaca, Murcia, Murcia, Spain"
      ],
      "name": "Eduardo Pinar-Bermúdez"
    },
    {
      "affiliations": [
        "Interventional Cardiology, Hospital Clínico San Carlos, Madrid, Spain",
        "Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid Madrid"
      ],
      "name": "Pilar Jiménez-Quevedo"
    },
    {
      "affiliations": [
        "Hospital Universitario Son Espases. Institut d'Investigació Sanitària Illes Balears, Palma, Spain",
        "London School of Hygiene and Tropical Medicine, London, London, UK",
        "Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain"
      ],
      "name": "Xavier Rosselló"
    },
    {
      "affiliations": [
        "London School of Hygiene and Tropical Medicine, London, London, UK"
      ],
      "name": "Stuart Pocock"
    },
    {
      "affiliations": [
        "Cardiovascular Institute Hospital Clinic, Barcelona, Spain"
      ],
      "name": "Manel Sabaté"
    },
    {
      "affiliations": [
        "Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Spain"
      ],
      "name": "Joan Antoni Gómez-Hospital"
    },
    {
      "affiliations": [
        "Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Spain",
        "Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain",
        "Instituto de Investigación Biomédica de Bellvitge, Barcelona, Spain"
      ],
      "name": "Josep Comin-Colet"
    },
    {
      "affiliations": [
        "Interventional Cardiology, Hospital Clínico San Carlos, Madrid, Spain",
        "Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid Madrid"
      ],
      "name": "Nieves Gonzalo"
    },
    {
      "affiliations": [
        "Interventional Cardiology, Hospital Clínico San Carlos, Madrid, Spain",
        "Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain"
      ],
      "name": "Antonio Fernández Ortiz"
    },
    {
      "affiliations": [],
      "name": "The SUGAR trial Investigators"
    }
  ],
  "title": "Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial",
  "uid": "b02ebc56-be0d-5d0b-abfb-6fcdefa66951"
}