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• W1995441335 abstract "Commentary on Garg AX, Devereaux PJ, Yusuf S, et al. Kidney function after off-pump or on-pump coronary artery bypass graft surgery. JAMA. 2014;311(21):2191-2198. Acute kidney injury (AKI) remains a controversial concept in nephrology. Considerable skepticism accompanied the first, second, and third iteration of the AKI consensus definition1Bellomo R. Ronco C. Kellum J.A. Mehta R.L. Palevsky P. Acute Dialysis Quality Initiative WorkgroupAcute renal failure—definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group.Crit Care. 2004; 8: R204-R212Crossref PubMed Google Scholar, 2Mehta R.L. Kellum J.A. Shah S.V. et al.Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury.Crit Care. 2007; 11: R31Crossref PubMed Scopus (5166) Google Scholar, 3Kellum J.A. Lameire N. KDIGO AKI Guideline Work GroupDiagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (part 1).Crit Care. 2013; 17: 204Crossref PubMed Scopus (1247) Google Scholar; publication of the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) Clinical Practice Guideline for AKI was followed immediately by an NKF-KDOQI (National Kidney Foundation–Kidney Disease Outcome Quality Initiative) commentary stating that there is “insufficient evidence to support [the KDIGO definition’s] widespread application to clinical care in the United States.”3Kellum J.A. Lameire N. KDIGO AKI Guideline Work GroupDiagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (part 1).Crit Care. 2013; 17: 204Crossref PubMed Scopus (1247) Google Scholar, 4Palevsky P.M. Liu K.D. Brophy P.D. et al.KDOQI US commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury.Am J Kidney Dis. 2013; 61: 649-672Abstract Full Text Full Text PDF PubMed Scopus (433) Google Scholar Similarly, the Canadian Society of Nephrology wrote, “it remains unclear how useful the current AKI staging system is in clinical practice.”5James M, Bouchard J, Ho J, et al. Canadian Society of Nephrology commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury. Am J Kidney Dis. 2013;61(5):673-685.Google Scholar One disputed element is the threshold by which AKI is defined. Few would argue that AKI requiring dialytic support is unimportant, but the prognosis of milder AKI is unclear. Although abundant observational evidence supports the association of small changes in serum creatinine levels with subsequent kidney function decline,6Coca S.G. Singanamala S. Parikh C.R. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis.Kidney Int. 2011; 81: 442-448Crossref PubMed Scopus (1354) Google Scholar many question whether the association reflects confounding (shared susceptibility) rather than causation. Small acute increases in creatinine levels might be an indicator of underlying kidney-related pathology rather than an instigator of irreparable kidney damage.7Hsu C.Y. Yes, AKI truly leads to CKD.J Am Soc Nephrol. 2012; 23: 967-969Crossref PubMed Scopus (124) Google Scholar, 8Rifkin D.E. Coca S.G. Kalantar-Zadeh K. Does AKI truly lead to CKD?.J Am Soc Nephrol. 2012; 23: 979-984Crossref PubMed Scopus (152) Google Scholar If the former, and AKI is analogous to a “positive stress test” for the kidneys, efforts at AKI prevention would have no effect on long-term kidney outcomes, and risk management after an AKI episode might be a more effective long-term strategy. How might the surrogacy of AKI for the development or progression of chronic kidney disease (CKD) be established?9Palevsky P.M. Molitoris B.A. Okusa M.D. et al.Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.Clin J Am Soc Nephrol. 2012; 7: 844-850Crossref PubMed Scopus (99) Google Scholar As suggested by Dr Garg and colleagues,10Garg AX, Devereaux PJ, Yusuf S, et al; CORONARY Investigators. Coronary Artery Bypass Grafting Surgery Off- or On-Pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial. BMJ Open. 2012;2(2):e001080.Google Scholar long-term follow-up of a randomized trial of an intervention for AKI prevention could provide unambiguous evidence. Unfortunately, and despite the impressive effort detailed in their article “Kidney Function After Off-Pump or On-Pump Coronary Artery Bypass Graft Surgery,”11Garg A.X. Devereaux P.J. Yusuf S. et al.Kidney function after off-pump or on-pump coronary artery bypass graft surgery: a randomized clinical trial.JAMA. 2014; 311: 2191-2198Crossref PubMed Scopus (138) Google Scholar results of this study do not help distinguish whether AKI itself leads to kidney disease progression. This kidney substudy of the parent trial Coronary Artery Bypass Grafting Surgery Off- or On-Pump Revascularisation Study (CORONARY) was designed to look at AKI and longer-term kidney outcomes after coronary artery bypass graft (CABG) surgery.11Garg A.X. Devereaux P.J. Yusuf S. et al.Kidney function after off-pump or on-pump coronary artery bypass graft surgery: a randomized clinical trial.JAMA. 2014; 311: 2191-2198Crossref PubMed Scopus (138) Google Scholar, 12Lamy A. Devereaux P.J. Prabhakaran D. et al.Off-pump or on-pump coronary-artery bypass grafting at 30 days.N Engl J Med. 2012; 366: 1489-1497Crossref PubMed Scopus (526) Google Scholar The study authors enrolled 2,932 patients from 63 sites in 16 countries, randomly assigning patients to off-pump (beating heart) or on-pump (traditional cardiopulmonary bypass) surgery. The primary postoperative outcome was ≥50% increase in creatinine level within 30 days of surgery, and the primary long-term outcome was ≥20% reduction in 1-year estimated glomerular filtration rate (eGFR), with both outcomes based on the difference from prerandomization levels. Alternative AKI definitions also were evaluated, including ≥100% increase in serum creatinine level (the definition used by Hou and colleagues13Hou S.H. Bushinsky D.A. Wish J.B. Cohen J.J. Harrington J.T. Hospital-acquired renal insufficiency: a prospective study.Am J Med. 1983; 74: 243-248Abstract Full Text PDF PubMed Scopus (980) Google Scholar, 14Nash K. Hafeez A. Hou S. Hospital-acquired renal insufficiency.Am J Kidney Dis. 2002; 39: 930-936Abstract Full Text Full Text PDF PubMed Scopus (1544) Google Scholar), ≥50% increase in serum creatinine level within 48 hours of surgery, and ≥50% increase in serum creatinine level within 5 days of surgery. Thirteen percent of patients did not return for 1-year creatinine measurement, including 4.9% who died during the first year after surgery. There was no significant difference in death or loss to follow-up between treatment groups. The study found that off-pump surgery was associated with a statistically significant reduction in AKI events for each near-term AKI definition, with 17.5% versus 20.8% experiencing AKI by the primary definition; 6.4% versus 8.0% by the Hou et al definition13Hou S.H. Bushinsky D.A. Wish J.B. Cohen J.J. Harrington J.T. Hospital-acquired renal insufficiency: a prospective study.Am J Med. 1983; 74: 243-248Abstract Full Text PDF PubMed Scopus (980) Google Scholar; 11.0% versus 14.7% by the 50%-over-48-hours definition; and 15.6% versus 18.4% by the 50%-over-5-day definition (P ≤ 0.05 for all comparisons). The relative and absolute risk reduction was greater among patients with pre-existing eGFR < 60 mL/min/1.73 m2. In contrast, there was no difference in 1-year kidney function between off-pump and on-pump surgery groups. The proportion with ≥20% reduction in eGFR was slightly higher in the off-pump group (17.1% vs 15.3%; P = 0.2). In observational-type analysis, in which AKI rather than randomization group was considered the exposure of interest, AKI was associated with a more than 3-fold increase in adjusted odds of ≥20% reduction in eGFR (adjusted odds ratio, 3.37; 95% confidence interval, 2.65-4.28; P < 0.001). This CORONARY substudy suggests that off-pump CABG surgery is slightly safer than on-pump surgery with respect to the development of postoperative AKI. This is a notable finding because few interventions exist that effectively prevent AKI.15Adabag A.S. Ishani A. Bloomfield H.E. Ngo A.K. Wilt T.J. Efficacy of N-acetylcysteine in preventing renal injury after heart surgery: a systematic review of randomized trials.Eur Heart J. 2009; 30: 1910-1917Crossref PubMed Scopus (80) Google Scholar, 16Kellum J.A. Decker J.M. Use of dopamine in acute renal failure: a meta-analysis.Crit Care Med. 2001; 29: 1526-1531Crossref PubMed Scopus (450) Google Scholar, 17Solomon R. Werner C. Mann D. D'Elia J. Silva P. Effects of saline, mannitol, and furosemide on acute decreases in renal function induced by radiocontrast agents.N Engl J Med. 1994; 331: 1416-1420Crossref PubMed Scopus (1156) Google Scholar, 18Park M. Coca S.G. Nigwekar S.U. Garg A.X. Garwood S. Parikh C.R. Prevention and treatment of acute kidney injury in patients undergoing cardiac surgery: a systematic review.Am J Nephrol. 2010; 31: 408-418Crossref PubMed Scopus (62) Google Scholar The risk reduction of 17% is consistent (albeit attenuated) compared with an earlier meta-analysis in which the off-pump technique was associated with a 40% reduction in postoperative AKI.19Seabra V.F. Alobaidi S. Balk E.M. Poon A.H. Jaber B.L. Off-pump coronary artery bypass surgery and acute kidney injury: a meta-analysis of randomized controlled trials.Clin J Am Soc Nephrol. 2010; 5: 1734-1744Crossref PubMed Scopus (98) Google Scholar Unfortunately, the benefit of off-pump surgery for AKI demonstrated in CORONARY did not translate to other outcomes. In the parent CORONARY trial, there was no significant reduction in the composite outcome of death, myocardial infarction, stroke, or kidney failure requiring dialysis at 30 days or 1 year.12Lamy A. Devereaux P.J. Prabhakaran D. et al.Off-pump or on-pump coronary-artery bypass grafting at 30 days.N Engl J Med. 2012; 366: 1489-1497Crossref PubMed Scopus (526) Google Scholar, 20Lamy A, Devereaux PJ, Prabhakaran D, et al; CORONARY Investigators. Effects of off-pump and on-pump coronary-artery bypass grafting at 1 year. N Engl J Med. 2013;368(13):1179-1188.Google Scholar In the CORONARY kidney substudy, there was no significant difference in 20% decrement in 1-year eGFR. These neutral results are consistent with previous randomized controlled trials of on-pump versus off-pump CABG surgery, which in meta-analysis showed no difference in the incidence of major adverse cardiovascular and cerebrovascular events at 1 year postsurgery.21Takagi H. Watanabe T. Mizuno Y. Kawai N. Umemoto T. ALICE (All-Literature Investigation of Cardiovascular Evidence) GroupA meta-analysis of large randomized trials for mid-term major cardio- and cerebrovascular events following off-pump versus on-pump coronary artery bypass grafting.Interact Cardiovasc Thorac Surg. 2014; 18: 522-524Crossref PubMed Scopus (10) Google Scholar In clinical practice, the advice regarding on-pump versus off-pump CABG delivered in the 2012 KDIGO guidelines still holds: off-pump techniques should not be encouraged “solely for the purpose of reducing perioperative AKI.”3Kellum J.A. Lameire N. KDIGO AKI Guideline Work GroupDiagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (part 1).Crit Care. 2013; 17: 204Crossref PubMed Scopus (1247) Google Scholar The benefits of the off-pump technique in AKI prevention appear mild, and the hard outcomes of mortality, myocardial infarction, and stroke appear unaffected by surgical type. One might argue that choice of on- or off-pump surgery also should take into account a given surgeon’s comfort with the technique. In research, implications of the CORONARY substudy are more nuanced. Proving that an intervention prevents AKI is exceedingly difficult.22Chertow G.M. Palevsky P.M. Greene T. Studying the prevention of acute kidney injury: lessons from an 18th-century mathematician.Clin J Am Soc Nephrol. 2006; 1: 1124-1127Crossref PubMed Scopus (33) Google Scholar Proving that an intervention that reduces AKI incidence therefore preserves kidney function in the longer term—in this sense, proving that AKI matters—is more challenging still. To illustrate somewhat simplistically, 5 factors must be considered in trial design: sample size, rate of AKI, effectiveness of the intervention in preventing AKI, rate of long-term kidney function decline, and magnitude of the association between AKI and long-term kidney function decline. In the present trial, the magnitude of AKI risk reduction and the magnitude of the association between AKI and the long-term outcome are most influential in determining power. CORONARY was an extremely large, well-run trial. Unfortunately, many of the mentioned observed factors were lower than in previous studies: the rate of AKI was 19%, compared to up to 30%23Rosner M.H. Okusa M.D. Acute kidney injury associated with cardiac surgery.Clin J Am Soc Nephrol. 2006; 1: 19-32Crossref PubMed Scopus (817) Google Scholar; AKI risk reduction was 17%, compared to 40%19Seabra V.F. Alobaidi S. Balk E.M. Poon A.H. Jaber B.L. Off-pump coronary artery bypass surgery and acute kidney injury: a meta-analysis of randomized controlled trials.Clin J Am Soc Nephrol. 2010; 5: 1734-1744Crossref PubMed Scopus (98) Google Scholar; incidence of the 1-year end point was 16%, compared to 26% incidence of CKD6Coca S.G. Singanamala S. Parikh C.R. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis.Kidney Int. 2011; 81: 442-448Crossref PubMed Scopus (1354) Google Scholar; and relative risk of 1-year decline in kidney function associated with AKI was 3.4, compared to a relative risk of developing CKD of 8.8.6Coca S.G. Singanamala S. Parikh C.R. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis.Kidney Int. 2011; 81: 442-448Crossref PubMed Scopus (1354) Google Scholar Thus, the most plausible explanation for the lack of significant 1-year effect is that the confluence of factors, particularly the smaller-than-expected reduction in AKI incidence and association between AKI and 20% eGFR decline, resulted in insufficient power, as the authors also suggest. So, does AKI itself cause longer-term kidney function decline? The answer seems to be that we still do not know. The authors of the CORONARY kidney substudy should be commended for their innovative approach to a difficult and controversial question. Although the import of AKI remains uncertain, a number of issues were raised that should inform future studies. More effective interventions are needed in order to demonstrate the long-term effects of AKI. A 1-year 20% decline in eGFR may not be sufficiently specific as a measure of longer-term kidney function. Indeed, the level of eGFR decline that constitutes meaningful CKD progression is under debate, and 1-year eGFR decline may exhibit weaker associations with subsequent end-stage renal disease than a similar decline observed over longer periods.24Coresh J. Turin Tc Matsushita K. et al.decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality.JAMA. 2014; 311: 2518-2531Crossref PubMed Scopus (631) Google Scholar Finally, we should bear in mind that other outcomes, such as hospital length of stay or hospital costs, may be important to consider. A small change in serum creatinine level may be meaningful for reasons other than its effect (or lack thereof) on longer-term kidney function. Support: Dr Grams is supported by National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases grant K08DK092287. Financial Disclosure: Drs Grams and Matsushita have received current and past research support from the NKF. Dr Sang declares that she has no relevant financial disclosures." @default.
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• W1995441335 title "Does Acute Kidney Injury Cause Longer-Term Kidney Function Decline?" @default.
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