Impact of renal insufficiency on safety and efficacy of drug-eluting stents compared to bare-metal stents at 6 years.

Background: There is few information on the long-term efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS) in all-comer percutaneous coronary intervention (PCI)-patients complicated by renal insufficiency (RI).

Objective: Our aim was to assess the 6-year clinical outcome of PCI-patients with RI treated exclusively with BMS, SES, or PES in our academic hospital.

Methods: A total of 1382 patients, included in three cohorts of consecutive PCI-patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft-Gault formula (normal kidney function ≥ 90; mild RI = 60-89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE).

Results: Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan-Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox-regression analysis, SES and PES decreased the occurrence of target-vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28-0.84; aHR = 0.75, 95% CI: 0.57-0.97, respectively] with no significant effect on mortality. Safety- and efficacy end points were comparable for the three stent types in patients with mild- and moderate renal function.

Conclusion: Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES- or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug-eluting stents over BMS in safety and efficacy end points for patients with impaired renal function.