Impaired renal function (IRF) was found to have negative long-term effects in individuals with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI), according to a study published in Clinical Research in Cardiology.
This was a prespecified analysis of the GLOBAL LEADERS study (Clinicaltrials.gov identifier: NCT01813435) in which 15,968 patients treated for ACS with PCI were enrolled. In this cohort, 15,883 participants had creatinine samples available2171 of whom had IRF (ie, glomerular filtration rate <60 mL/min/1.73 m²). Study participants were randomly assigned to receive ticagrelor therapy (1 month of aspirin plus ticagrelor, followed by 23 months of ticagrelor alone) or reference treatment (aspirin plus clopidogrel or ticagrelor for 1 year, followed by aspirin alone for 1 year). A composite of new Q-wave myocardial infarction and all-cause mortality in the 2 years following PCI was the primary study endpoint.
The presence vs absence of IRF was associated with a higher rate of the composite primary endpoint (hazard ratio [HR], 1.64; 95% CI, 1.35-1.98; P adjusted =.001), as well as all-cause mortality (HR, 1.82; 95% CI, 1.46-2.26; P adjusted =.001), myocardial infarction (HR, 1.55; 95% CI, 1.22-1.96; P adjusted =.001), and all revascularization procedures (HR, 1.19; 95% CI, 1.02-1.37; P adjusted =.023).
The primary endpoint occurred in 7.2% of patients with IRF who received the ticagrelor therapy vs 8.7% of participants with IRF receiving the reference treatment (P =.680). The treatment was not found to affect the rates of BARC-defined type 3 or 5 bleeding (P =.656), or all-cause death (P =.105) in patients with IRF. Although participants with ACS and IRF in both groups had similar rates of the primary endpoint (P =.094) and bleeding (P =.227), participants receiving ticagrelor therapy vs reference treatment had a lower rate of patient oriented composite endpoint of all-cause death, myocardial infarction, stroke, or revascularization (P =.028) and net adverse clinical events (P =.045). The presence of IRF was not found to have an impact on treatment effects in patients with stable coronary artery disease.
Study limitations include exploratory/hypothesis-generating results, potential imbalance between groups, and a potential for bias and/or misclassification.
“IRF is associated with worse short- and long-term clinical outcomes after PCI,” noted the study authors. “There was no differential treatment effects found with regard to all-cause death or new Q-wave [myocardial infarction] after PCI in patients with IRF treated with ticagrelor monotherapy after 1-month dual therapy with aspirin.”
Disclosure: This clinical trial was supported by Biosensors International, AstraZeneca, and the Medicines Company. Please see the original reference for a full list of authors’ disclosures.
Tomaniak M, Chichareon P, Klimczak-Tomaniak D, et al. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial [published online January 10, 2020]. Clin Res Cardiol. doi: 10.1007/s00392-019-01586-9