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

• Published in: Catheterization and cardiovascular interventions Vol. 80; no. 1; pp. 18 - 26
• Main Authors: Simsek, Cihan, Magro, Michael, Boersma, Eric, Onuma, Yoshinobu, Nauta, Sjoerd, Valstar, Gideon, van Geuns, Robert-Jan, van der Giessen, Willem, van Domburg, Ron, Serruys, Patrick
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.07.2012
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Angioplasty, Balloon, Coronary - mortality; Biomarkers - blood; Cardiovascular Agents - administration & dosage; Chi-Square Distribution; Coronary Artery Disease - complications; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Creatinine - blood; Drug-Eluting Stents; Female; Glomerular Filtration Rate; Humans; Kaplan-Meier Estimate; Kidney - metabolism; Kidney - physiopathology; kidney function; Male; Metals; Middle Aged; Multivariate Analysis; Netherlands; Paclitaxel - administration & dosage; Patient Safety; percutaneous coronary intervention; Proportional Hazards Models; Prosthesis Design; Registries; Renal Insufficiency - blood; Renal Insufficiency - complications; Renal Insufficiency - mortality; Renal Insufficiency - physiopathology; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus - administration & dosage; Stents; Time Factors; Treatment Outcome; Netherlands
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.23199

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. © 2012 Wiley Periodicals, Inc.