The impact of renal impairment on long-term safety and effectiveness of drug-eluting stents

PLoS One. 2014 Sep 3;9(9):e106450. doi: 10.1371/journal.pone.0106450. eCollection 2014.

Abstract

Background: Renal impairment (RI) is associated with impaired prognosis in patients with coronary artery disease. Clinical and angiographic outcomes of patients undergoing percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in this patient population are not well established.

Methods: We pooled individual data for 5,011 patients from 3 trials with the exclusive and unrestricted use of DES (SIRTAX - N = 1,012, LEADERS - N = 1,707, RESOLUTE AC - N = 2,292). Angiographic follow-up was available for 1,544 lesions. Outcomes through 2 years were stratified according to glomerular filtration rate (normal renal function: GFR ≥ 90 ml/min; mild RI: 90<GFR ≥ 60 ml/min; moderate/severe RI GFR<60 ml/min).

Results: Patients with moderate/severe RI had an increased risk of cardiac death or myocardial infarction ([MI], OR 2.14, 95%CI 1.36-3.36), cardiac death (OR 2.21, 95%CI 1.10-4.46), and MI (OR 2.02, 95%CI 1.19-3.43) compared with patients with normal renal function at 2 years follow-up. There was no difference in cardiac death or MI between patients with mild RI compared to those with normal renal function (OR 1.10, 95%CI 0.75-1.61). The risk of target-lesion revascularization was similar for patients with moderate/severe RI (OR 1.17, 95%CI 0.70-1.95) and mild RI (OR 1.16, 95%CI 0.81-1.64) compared with patients with normal renal function. In-stent late loss and in-segment restenosis were not different for patients with moderate/severe RI, mild RI, and normal renal function.

Conclusions: Renal function does not affect clinical and angiographic effectiveness of DES. However, prognosis remains impaired among patients with moderate/severe RI.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary
  • Clinical Trials as Topic
  • Coronary Angiography
  • Coronary Artery Disease / complications
  • Coronary Artery Disease / drug therapy*
  • Coronary Artery Disease / pathology
  • Drug-Eluting Stents / adverse effects*
  • Humans
  • Renal Insufficiency / chemically induced
  • Renal Insufficiency / pathology*
  • Risk Factors
  • Treatment Outcome

Grants and funding

Funding for the current analysis was provided in part by a grant of the Swiss National Science Foundation (grant 33CM30-140336). Dr. Stefanini is the recipient of a research fellowship (SPUM) of the Swiss National Science Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.