Drug-Eluting Versus Bare-Metal Stents During PCI in Patients With End-Stage Renal Disease on Dialysis

Abstract

Background: In patients undergoing percutaneous coronary intervention (PCI), drug-eluting stents (DES) reduce repeat revascularizations compared with bare-metal stents (BMS), but their effects on death and myocardial infarction (MI) are mixed. Few studies have focused on patients with end-stage renal disease.

Objectives: This study compared mortality and cardiovascular morbidity during percutaneous coronary intervention with DES and with BMS in dialysis patients.

Methods: We identified 36,117 dialysis patients from the USRDS (United States Renal Data System) who had coronary stenting in the United States between April 23, 2003, and December 31, 2010, and examined the association of DES versus BMS with 1-year outcomes: death; death or MI; and death, MI, or repeat revascularization. We also conducted a temporal analysis by dividing the study period into 3 DES eras: Transitional (April 23, 2003, to June 30, 2004); Liberal (July 1, 2004, to December 31, 2006); and Selective (January 1, 2007, to December 31, 2010).

Results: One-year event rates were high, with 38 deaths; 55 death or MI events; and 71 death, MI, or repeat revascularization events per 100 person-years. DES, compared with BMS, were associated with a significant 18% lower risk of death; 16% lower risk of death or MI; and 13% lower risk of death, MI, or repeat revascularization. DES use varied, from 56% in the Transitional era to 85% in the Liberal era and 62% in the Selective era. DES outcomes in the Liberal era were significantly better than in the Transitional Era, but not significantly better than in the Selective Era.

Conclusions: DES for percutaneous coronary intervention appears to be safe for use in U.S. dialysis patients and is associated with lower rates of death, MI, and repeat revascularization.

Keywords: cardiovascular disease; end-stage renal disease; epidemiology; hemodialysis; ischemic heart disease; renal insufficiency.

Central Illustration: Stent Type and Outcomes in Dialysis: Direct comparison of drug-eluting stents and bare metal stents in patients on dialysis

Hazard ratios comparing drug-eluting stents with bare-metal stents after percutaneous coronary intervention in patients with end-stage renal disease on dialysis for the specified outcomes using 2 different analytical approaches. Error bars represent 95% confidence intervals [CI]. Abbreviations: MI = myocardial infarction; Revasc = revascularization. Abbreviations: ESRD = end-stage renal disease on dialysis; PCI = percutaneous coronary intervention; DES = drug-eluting stent; BMS = bare metal stent.

Figure 1. Cohort assembly flow diagram

Assembly of cohort of patients with ESRD on dialysis who underwent percutaneous coronary intervention with stenting after drug-eluting stents became available in the United States.

Figure 2. Changing patterns of drug-eluting stent use in patients on dialysis from April 2003 – Dec 2010

Proportion of patients with end-stage renal disease on dialysis receiving drug-eluting stents (DES) or bare metal stents (BMS) during percutaneous coronary intervention in 3 different drug-eluting stent eras: Transitional: 4/23/03–6/30/04; Liberal: 7/1/04–12/31/06; and Selective: 1/1/07–12/31/10.

Figure 3. Temporal analysis comparing outcomes by drug-eluting stent era in patients on dialysis

Kaplan-Meier curves by drug-eluting stent era, with unadjusted and adjusted hazard ratios (95% confidence intervals) comparing Transitional and Selective versus Liberal drug-eluting stent eras for the following 1-year outcomes after percutaneous coronary intervention: (A) death; (B) death or myocardial infarction [MI]; and (C) death, myocardial infarction or repeat revascularization [RR].

Figure 3. Temporal analysis comparing outcomes by drug-eluting stent era in patients on dialysis

Kaplan-Meier curves by drug-eluting stent era, with unadjusted and adjusted hazard ratios (95% confidence intervals) comparing Transitional and Selective versus Liberal drug-eluting stent eras for the following 1-year outcomes after percutaneous coronary intervention: (A) death; (B) death or myocardial infarction [MI]; and (C) death, myocardial infarction or repeat revascularization [RR].

Figure 3. Temporal analysis comparing outcomes by drug-eluting stent era in patients on dialysis

Kaplan-Meier curves by drug-eluting stent era, with unadjusted and adjusted hazard ratios (95% confidence intervals) comparing Transitional and Selective versus Liberal drug-eluting stent eras for the following 1-year outcomes after percutaneous coronary intervention: (A) death; (B) death or myocardial infarction [MI]; and (C) death, myocardial infarction or repeat revascularization [RR].