Your browser doesn't support javascript.
loading
Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials.
Ploumen, Eline H; Pinxterhuis, Tineke H; Zocca, Paolo; Roguin, Ariel; Anthonio, Rutger L; Schotborgh, Carl E; Benit, Edouard; Aminian, Adel; Danse, Peter W; Doggen, Carine J M; von Birgelen, Clemens; Kok, Marlies M.
Afiliación
  • Ploumen EH; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, The Netherlands.
  • Pinxterhuis TH; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, Netherlands.
  • Zocca P; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, The Netherlands.
  • Roguin A; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, Netherlands.
  • Anthonio RL; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, The Netherlands.
  • Schotborgh CE; Department of Cardiology, Hadera and B. Rappaport-Faculty of Medicine, Hillel Yaffe Medical Center, Israel Institute of Technology, Haifa, Israel.
  • Benit E; Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, Netherlands.
  • Aminian A; Department of Cardiology, Haga Hospital, The Hague, Netherlands.
  • Danse PW; Department of Cardiology, Jessa Hospital, Hasselt, Belgium.
  • Doggen CJM; Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
  • von Birgelen C; Department of Cardiology, Rijnstate Hospital, Arnhem, Netherlands.
  • Kok MM; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, Netherlands.
Cardiovasc Diabetol ; 20(1): 217, 2021 10 30.
Article en En | MEDLINE | ID: mdl-34717627
BACKGROUND: Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. METHODS: For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. RESULTS: Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38-2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85-2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49-5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29-2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03-2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23-2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant. CONCLUSIONS: Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. TRIAL REGISTRATION: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.
Asunto(s)
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estado Prediabético / Glucemia / Enfermedad de la Arteria Coronaria / Diabetes Mellitus / Stents Liberadores de Fármacos / Intervención Coronaria Percutánea Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Cardiovasc Diabetol Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / ENDOCRINOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estado Prediabético / Glucemia / Enfermedad de la Arteria Coronaria / Diabetes Mellitus / Stents Liberadores de Fármacos / Intervención Coronaria Percutánea Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Cardiovasc Diabetol Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / ENDOCRINOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido