Background: Mortality and restenosis may be increased in patients with mild to moderate renal insufficiency (RI) after coronary stent implantation. Whether drug-eluting stents safely reduce restenosis and enhance event-free survival in these patients is unknown. We sought to evaluate the impact of baseline RI on clinical and angiographic outcomes in patients undergoing elective percutaneous coronary intervention using either bare metal or paclitaxel-eluting stents.
Methods: In the TAXUS-IV trial, 1314 patients were randomized to either the polymer-based paclitaxel-eluting TAXUS stent or an identical-appearing bare metal stent. Outcomes were stratified on the basis of the presence of RI, defined as a baseline creatinine clearance < 60 cm3/min calculated by the Cockcroft-Gault formula.
Results: Baseline RI was present in 223 (17.2%) patients, in whom the mean creatinine clearance was 49.6 +/- 8.5 cm3/min. Compared with bare metal stents, treatment with the TAXUS stent resulted in lower rates of 9-month angiographic restenosis rates in both patients with (2.1% vs 20.5%, P = .009) and without (9.2% vs 27.8%, P < .0001) baseline RI. Similarly, 1-year target lesion revascularization rates were reduced with the TAXUS stent in patients with (3.3% vs 12.2%, P = .01) and without (4.7% vs 15.8%, P < .0001) baseline RI. The occurrence of death, myocardial infarction, and stent thrombosis at 1 year were similar in both randomization groups, independent of renal function.
Conclusions: The polymer-based paclitaxel-eluting TAXUS stent safely reduces clinical and angiographic restenosis in patients with preserved as well as moderate impairment of baseline renal function.