Abstract 2536: Impact Of Moderate Renal Insufficiency on Restenosis and Adverse Clinical Events After Sirolimus-eluting and Bare Metal Stent Implantation: Results from the Sirius Trials
BACKGROUND: Patients with renal insufficiency (RI) are known to have worse acute and late clinical outcomes after percutaneous coronary intervention (PCI) in observational studies. Whether drug-eluting stents are effective and safe in patients with moderate RI is unknown.
METHODS: We performed a pooled analysis of data from 3 blinded randomized trials of sirolimus-eluting (SES) vs. bare metal stent (BMS; SIRIUS, C-SIRIUS, E-SIRIUS) which included a total of 1510 patients. Clinical and angiographic outcomes were stratified on the basis of the presence of RI defined by creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula (normal >/=90 mL/min; mild 60 – 89 mL/min; moderate >60 mL/min). Patients with baseline creatinine <3.0 mg/dL were excluded from these trials.
RESULTS: Baseline mild RI was present in 517 patients (34.7%; mean CrCl 75.7 mL/min) and moderate RI in 228 patients (15.3%; mean CrCl 47.2 mL/min). Treatment with SES resulted in lower rates of 8-month angiographic restenosis rates in patients with RI (mild RI: 6.7% vs. 42.6%, p<0.001; moderate RI: 9.7% vs. 39.7%, p<0.001) and without (7.7% vs. 37.2%, p<0.001) baseline RI. 1-year target vessel revascularization rates were similarly reduced with SES in patients with (mild RI: 4.7% vs. 24.2%, p<0.001; moderate RI: 5.5% vs. 26.9%, p<0.001) and without (8.1% vs. 22.4%, p<0.001) baseline RI, and this benefit was maintained at 5 years (Table⇓). Patients with moderate RI had higher rates of overall mortality and cardiac death at 5 years; however, there was no differential effect of SES vs. BMS on any safety endpoint (Table⇓).
CONCLUSIONS: Patients with moderate RI have a nearly 3-fold increase in 5-year mortality after PCI compared with patients without RI. Despite the high risk of clinical events in these patients, the effectiveness of SES in reducing restenosis compared with BMS in patients with moderate RI was not diminished and the rates of death and MI were not adversely affected by SES treatment.