Everolimus Eluting Stents in Patients with Diabetes Mellitus and Chronic Kidney Disease: Insights from the TUXEDO Trial

Autor: Sripal Bangalore, R.K. Jain, R.K. Prem Chand, Rajpal K. Abhaichand, Upendra Kaul, Ajit S. Mullasari, Priyadarshini Arambam
Rok vydání: 2019
Předmět:
Male
medicine.medical_specialty
Time Factors
Paclitaxel
medicine.medical_treatment
Myocardial Infarction
India
Renal function
Coronary Artery Disease
030204 cardiovascular system & hematology
Kidney
Prosthesis Design
urologic and male genital diseases
Risk Assessment
Coronary artery disease
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Risk Factors
Internal medicine
Diabetes mellitus
Diabetes Mellitus
medicine
Humans
Everolimus
030212 general & internal medicine
Renal Insufficiency
Chronic
Aged
business.industry
Coronary Thrombosis
Stent
Cardiovascular Agents
Drug-Eluting Stents
General Medicine
Middle Aged
medicine.disease
Clinical trial
Treatment Outcome
Cohort
Cardiology
Female
Cardiology and Cardiovascular Medicine
business
Mace
Glomerular Filtration Rate
Kidney disease
Zdroj: Cardiovascular Revascularization Medicine. 20:1075-1080
ISSN: 1553-8389
DOI: 10.1016/j.carrev.2019.02.017
Popis: Background Patients with diabetes and those with chronic kidney disease (CKD) are at increased risk of cardiovascular events. Everolimus eluting stents (EES) have been shown to be superior to paclitaxel eluting stents (PES) in patients with diabetes. However, it is not known if EES is as beneficial in diabetic patients with CKD compared with those without CKD. Methods and results Patients enrolled in the TUXEDO-India trial, which is a clinical trial of patients with diabetes and coronary artery disease (CAD) randomly assigned to EES vs. thin-strut PES (Taxus Element), with data on baseline renal function were selected. CKD was defined as an estimated glomerular filtration rate (eGFR) Among the 1821 patients with diabetes included in this analysis, 344 (19%) had CKD. In a propensity score adjusted analysis, patients with CKD had a significant increase in MACE (HR = 2.02; 95% CI 1.17–3.50; P = 0.01); death/MI/TVR (HR = 1.99; 95% CI 1.18–3.34; P = 0.009); death/MI (HR = 2.31; 95% CI 1.30–4.08; P = 0.004); cardiac death/MI (HR = 2.40; 95% CI 1.31–4.42; P = 0.005); death (HR = 2.88; 95% CI 1.35–6.13; P = 0.006) driven by an increase in cardiac death (HR = 3.33; 95% CI 1.42–7.83; P = 0.006) when compared with those without CKD. However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups. A significant interaction between CKD status and stent type (EES vs. PES) was noted for the outcomes of TVF (Pinteraction = 0.046), MACE (Pinteraction = 0.02), cardiac death or MI (Pinteraction = 0.05), non-target vessel related MI (Pinteraction = 0.04), non-Q-wave MI (Pinteraction = 0.03) and deaths/MI/TVR (Pinteraction = 0.04) such that EES was superior to PES in the non-CKD cohort but not in the CKD cohort. Conclusions In subjects with diabetes, CKD is an independent predictor of adverse cardiovascular outcomes including increased risk of death driven largely by non-stent related events. While EES was superior to PES in patients without CKD, this was not the case in those with CKD (Clinical Trials Registry-India number, CTRI/2011/06/001830).
Databáze: OpenAIRE
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