Renal Impairment and Outcomes After Sirolimus-Eluting Stent Implantation
Renal Impairment and Outcomes After Sirolimus-Eluting Stent Implantation
Background The presence of chronic kidney disease (CKD) is associated with an increased risk of restenosis and major adverse cardiac events (MACEs) after coronary interventions, especially in patients on hemodialysis (HD). The aim of this study was to assess the impact of varying degrees of renal impairment on angiographic and 2-year clinical outcomes after treatment with sirolimus-eluting stents (SESs).
Methods A total of 675 lesions of 593 patients treated with SES were analyzed. Patients were classified into 3 groups: 34 patients on HD; 337 patients with estimated glomerular filtration rate ≥60 mL min 1.73 m (non-CKD group); and 222 patients who had lower estimated glomerular filtration rate <60 mL min 1.73 min without HD dependency (CKD group).
Results At angiographic follow-up (201 ± 73 days), in-segment late loss was markedly higher in the HD group versus the non-CKD and CKD groups (0.68 ± 1.06 vs 0.11 ± 0.45 and 0.15 ± 0.50 mm, respectively, P < .001), resulting in a significantly higher in-segment restenosis rate (40.0% vs 10.4% and 11.5%, respectively, P < .001). At 2 years, HD vs non-CKD and CKD was associated with a significantly higher MACE rate (35.3% vs 10.4% and 12.6%, respectively, P < .001), mainly driven by significantly higher mortality (11.8% vs 0.6% and 2.3%, respectively, P < .001) and target-lesion revascularization (23.5% vs 9.2% and 8.1%, respectively, P = .016) rates. Multivariable analysis revealed that HD was the independent predictor of 2-year MACE (hazard ratio 4.70, 95% CI 2.40–9.20, P < .001).
Conclusions Although angiographic and clinical outcomes after SES implantation were similarly favorable in non–HD-dependent CKD patients, regardless of renal function, in patients with end-stage CKD requiring HD, frequencies of restenosis and 2-year MACE were markedly higher than in non–HD-dependent patients. (Am Heart J 2009;158:92–8.)
Chronic kidney disease (CKD) prevalence has been increasing recently at remarkable rates in many countries. Advanced coronary artery disease and acute cardiac events are the most common causes of death in this population, and the presence of CKD or renal failure also is associated with an increased risk of restenosis and major adverse cardiac events (MACEs) after either balloon angioplasty alone or bare-metal stent (BMS) implantation especially in cases with end-stage renal disease including those on hemodialysis (HD). Several trials documented that use of sirolimus-eluting stents (SESs) reduced restenosis and subsequent target-vessel revascularization rates compared with use of BMS, even in patients with off-label indications, resulting in widespread use of SES in clinical practice. Recently published trials using SES, however, failed to demonstrate a consistent effect of SES over BMS on clinical outcomes in patients with CKD and/or HD dependence, which also showed conflicting results in terms of restenosis rates. In these studies, the impact of varying degrees of renal impairment on angiographic and clinical outcomes after SES implantation had not been fully evaluated, particularly in long-term follow-up and, accordingly, the goal of the present study was to assess the relationship between severity of renal dysfunction and angiographic and 2-year clinical outcomes throughout a broad range of renal function level including HD-dependent patients.
Abstract and Introduction
Abstract
Background The presence of chronic kidney disease (CKD) is associated with an increased risk of restenosis and major adverse cardiac events (MACEs) after coronary interventions, especially in patients on hemodialysis (HD). The aim of this study was to assess the impact of varying degrees of renal impairment on angiographic and 2-year clinical outcomes after treatment with sirolimus-eluting stents (SESs).
Methods A total of 675 lesions of 593 patients treated with SES were analyzed. Patients were classified into 3 groups: 34 patients on HD; 337 patients with estimated glomerular filtration rate ≥60 mL min 1.73 m (non-CKD group); and 222 patients who had lower estimated glomerular filtration rate <60 mL min 1.73 min without HD dependency (CKD group).
Results At angiographic follow-up (201 ± 73 days), in-segment late loss was markedly higher in the HD group versus the non-CKD and CKD groups (0.68 ± 1.06 vs 0.11 ± 0.45 and 0.15 ± 0.50 mm, respectively, P < .001), resulting in a significantly higher in-segment restenosis rate (40.0% vs 10.4% and 11.5%, respectively, P < .001). At 2 years, HD vs non-CKD and CKD was associated with a significantly higher MACE rate (35.3% vs 10.4% and 12.6%, respectively, P < .001), mainly driven by significantly higher mortality (11.8% vs 0.6% and 2.3%, respectively, P < .001) and target-lesion revascularization (23.5% vs 9.2% and 8.1%, respectively, P = .016) rates. Multivariable analysis revealed that HD was the independent predictor of 2-year MACE (hazard ratio 4.70, 95% CI 2.40–9.20, P < .001).
Conclusions Although angiographic and clinical outcomes after SES implantation were similarly favorable in non–HD-dependent CKD patients, regardless of renal function, in patients with end-stage CKD requiring HD, frequencies of restenosis and 2-year MACE were markedly higher than in non–HD-dependent patients. (Am Heart J 2009;158:92–8.)
Introduction
Chronic kidney disease (CKD) prevalence has been increasing recently at remarkable rates in many countries. Advanced coronary artery disease and acute cardiac events are the most common causes of death in this population, and the presence of CKD or renal failure also is associated with an increased risk of restenosis and major adverse cardiac events (MACEs) after either balloon angioplasty alone or bare-metal stent (BMS) implantation especially in cases with end-stage renal disease including those on hemodialysis (HD). Several trials documented that use of sirolimus-eluting stents (SESs) reduced restenosis and subsequent target-vessel revascularization rates compared with use of BMS, even in patients with off-label indications, resulting in widespread use of SES in clinical practice. Recently published trials using SES, however, failed to demonstrate a consistent effect of SES over BMS on clinical outcomes in patients with CKD and/or HD dependence, which also showed conflicting results in terms of restenosis rates. In these studies, the impact of varying degrees of renal impairment on angiographic and clinical outcomes after SES implantation had not been fully evaluated, particularly in long-term follow-up and, accordingly, the goal of the present study was to assess the relationship between severity of renal dysfunction and angiographic and 2-year clinical outcomes throughout a broad range of renal function level including HD-dependent patients.
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