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The effect of lowering LDL cholesterol on vascular access patency : post hoc analysis of the Study of Heart and Renal Protection . BACKGROUND AND OBJECTIVES Reducing LDL cholesterol ( LDL-C ) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD , including dialysis patients , but the effect of lowering LDL-C on vascular access patency is unclear . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS The Study of Heart and Renal Protection ( SHARP ) randomized patients with CKD to 20 mg simvastatin plus 10 mg ezetimibe daily versus matching placebo . This study aimed to explore the effects of treatment on vascular access occlusive events , defined as any access revision procedure , access thrombosis , removal of an old dialysis access , or formation of new permanent dialysis access . RESULTS Among 2353 SHARP participants who had functioning vascular access at randomization , allocation to simvastatin plus ezetimibe resulted in a 13 % proportional reduction in vascular access occlusive events ( 355 [ 29.7 % ] for simvastatin/ezetimibe versus 388 [ 33.5 % ] for placebo ; risk ratio [ RR ] , 0.87 ; 95 % confidence interval [ 95 % CI ] , 0.75 to 1.00 ; P=0.05 ) . There was no evidence that the effects of treatment differed for any of the separate components of this outcome . To test the hypothesis raised by SHARP , comparable analyses were performed using the AURORA ( A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis : An Assessment of Survival and Cardiovascular Events ) trial cohort . AURORA did not provide independent confirmation ( vascular access occlusive events : 352 [ 28.9 % ] for rosuvastatin versus 337 [ 27.6 % ] for placebo ; RR , 1.06 , 95 % CI , 0.91 to 1.23 ; P=0.44 ) . After combining the two trials , the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant ( 707 [ 29.3 % ] with any LDL-C-lowering therapy versus 725 [ 30.5 % ] with placebo ; RR , 0.95 , 95 % CI , 0.85 to 1.05 ; P=0.29 ) . CONCLUSIONS Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency , but there was no evidence of benefit in AURORA . Taken together , the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest .
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Intervention_Pharmacological
statin-based therapy
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Intervention_Pharmacological
20 mg simvastatin plus 10 mg ezetimibe daily
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Intervention_Control
placebo
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Intervention_Pharmacological
simvastatin/ezetimibe
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Intervention_Control
placebo
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Intervention_Pharmacological
statin-based therapy
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Outcome_Other
any access revision procedure
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Outcome_Other
access thrombosis
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Outcome_Other
removal of an old dialysis access
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Outcome_Other
formation of new permanent dialysis access
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Outcome_Other
reduction in vascular access occlusive events
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Outcome_Physical
LDL-C
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Participant_Condition
patients with CKD , including dialysis patients
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Participant_Condition
CKD
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Participant_Sample-size
2353
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Participant_Condition
who had functioning vascular access