Therapeutics
Early high-dose rosuvastatin prevented contrast-induced acute kidney injury in non–ST-elevation ACS
Leoncini M, Toso A, Maioli M, et al. Early high-dose rosuvastatin for contrast-induced nephropathy prevention in acute coronary syndrome: results from the PRATO-ACS Study. J Am Coll Cardiol. 2014;63:71-9.
Clinical impact ratings: h ★★★★★★✩ C ★★★★★★✩ n ★★★★★★✩ Question
Conclusion
In patients with non–ST-elevation acute coronary syndrome (NSTE-ACS) who are scheduled for early invasive strategy, does early administration of high-dose rosuvastatin prevent contrastinduced acute kidney injury (CI-AKI)?
In patients with non–ST-elevation acute coronary syndrome who were scheduled for early invasive strategy, early administration of high-dose rosuvastatin prevented contrast-induced acute kidney injury more than control.
Methods
*Information provided by author.
Design: Randomized controlled trial (Protective effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome [PRATO-ACS] study). Clinical Trials.gov NCT01185938. Allocation: {Unconcealed}*.† Follow-up period: 30 days. Setting: 1 clinical center in Italy. Patients: 543 patients (mean age 66 y, 66% men) who had NSTEACS and were scheduled for early invasive strategy. Exclusion criteria included current statin treatment, acute renal failure or end-stage renal failure requiring dialysis, need for emergency coronary angiography within 2 hours, serum creatinine ≥ 3 mg/dL, contraindication to early invasive strategy or statin treatment, or use of contrast medium within the past 10 days. Intervention: Rosuvastatin, 40 mg at randomization followed by 20 mg/d (n = 271), or no statin until atorvastatin, 40 mg/d, after discharge (n = 272). Outcomes: CI-AKI (serum creatinine ≥ 0.5 mg/dL or ≥ 25% increase in baseline value within 72 h of contrast agent administration). Secondary outcomes included adverse events at 30 days. Patient follow-up: 93% at 30 days.
Main results Time from randomization (and study drug administration) to contrast medium administration ranged from 15 to 44 hours. Rosuvastatin reduced risk for CI-AKI more than control (Table); in planned subgroup comparisons, CI-AKI did not differ by presence of diabetes (P = 0.49 for interaction) or by baseline estimated creatinine clearance (< 60 mL/min vs ≥ 60 mL/min) (P = 0.79 for interaction). Compared with the control group, the rosuvastatin group was less likely to have adverse cardiovascular or renal events at 30 days (3.6% vs 7.9%, P = 0.036). Early high-dose rosuvastatin vs control in patients with non–ST-elevation acute coronary syndrome having an early invasive strategy‡
CI-AKI at 72 h§
Event rate Rosuvastatin Control 6.7%
Source of funding: Centro Cardiopatici Toscani. For correspondence: Dr. A. Toso, Misericordia e Dolce Hospital, Prato, Italy. E-mail [email protected]. ■
Commentary
Blinding: Unblinded.†
Outcome
†See Glossary.
15%
RRR (95% CI)
NNT (CI)
58% (26 to 77)
12 (9 to 26)
‡CI-AKI = contrast-induced acute kidney injury; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rate and adjusted odds ratio in article.
CI-AKI is common after coronary angiography. The finding of a beneficial effect of rosuvastatin in reducing CI-AKI in the Italian trial by Leoncini and colleagues is not consistent with all previous trials (1). However, the result does align with 3 other trials, including the trial from Han and colleagues of almost 3000 patients recruited from 53 centers in China (1, 2). Inconsistent results across published trials may relate to methodology, including small sample sizes, open-label design, and differing definitions of CI-AKI. The type of statin may also be important; Leoncini and colleagues and Han and colleagues (2) tested rosuvastatin (a hydrophilic statin), whereas other trials tested simvastatin and atorvastatin (hydrophobic statins). Current American College of Cardiology/American Heart Association guidelines recommend statin initiation before discharge after an admission for a NSTE-ACS. Given the growing evidence that statins given before, rather than after, angiography reduce renal and cardiovascular events (2, 3), it seems reasonable to recommend high-dose rosuvastatin before angiography; patients could be switched to another statin at discharge if desired. Current evidence suggests that the potential harms of such an approach would be minimal. It may also be useful to clarify the benefit–risk profile of preangiography rosuvastatin in subpopulations with advanced chronic kidney disease, ejection fraction < 30%, or a very high CI-AKI risk score. Such patients were excluded or participated in small numbers in the trials by Leoncini and colleagues and Han and colleagues (2). Amber O. Molnar, MD University of Ottawa Ottawa, Ontario, Canada Amit X. Garg, MD Western University London, Ontario, Canada References 1. Mao S, Huang S. Ren Fail. 2014 Feb 6. [Epub ahead of print] 2. Han Y, Zhu G, Han L, et al. J Am Coll Cardiol. 2014;63:62-70. 3. Benjo AM, El-Hayek GE, Messerli F, et al. Catheter Cardiovasc Interv. 2013. [Epub ahead of print]
§Serum creatinine ≥ 0.5 mg/dL or ≥ 25% increase in baseline value within 72 h of contrast agent administration.
20 May 2014 | ACP Journal Club | Volume 160 • Number 10
© 2014 American College of Physicians
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/930210/ by a NYU Medical Center Library User on 03/20/2017
JC9
Early high-dose rosuvastatin prevented contrast-induced acute kidney injury in non–ST-elevation ACS
Leoncini M, Toso A, Maioli M, et al. Early high-dose rosuvastatin for contrast-induced nephropathy prevention in acute coronary syndrome: results from the PRATO-ACS Study. J Am Coll Cardiol. 2014;63:71-9.
Clinical impact ratings: h ★★★★★★✩ C ★★★★★★✩ n ★★★★★★✩ Question
Conclusion
In patients with non–ST-elevation acute coronary syndrome (NSTE-ACS) who are scheduled for early invasive strategy, does early administration of high-dose rosuvastatin prevent contrastinduced acute kidney injury (CI-AKI)?
In patients with non–ST-elevation acute coronary syndrome who were scheduled for early invasive strategy, early administration of high-dose rosuvastatin prevented contrast-induced acute kidney injury more than control.
Methods
*Information provided by author.
Design: Randomized controlled trial (Protective effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome [PRATO-ACS] study). Clinical Trials.gov NCT01185938. Allocation: {Unconcealed}*.† Follow-up period: 30 days. Setting: 1 clinical center in Italy. Patients: 543 patients (mean age 66 y, 66% men) who had NSTEACS and were scheduled for early invasive strategy. Exclusion criteria included current statin treatment, acute renal failure or end-stage renal failure requiring dialysis, need for emergency coronary angiography within 2 hours, serum creatinine ≥ 3 mg/dL, contraindication to early invasive strategy or statin treatment, or use of contrast medium within the past 10 days. Intervention: Rosuvastatin, 40 mg at randomization followed by 20 mg/d (n = 271), or no statin until atorvastatin, 40 mg/d, after discharge (n = 272). Outcomes: CI-AKI (serum creatinine ≥ 0.5 mg/dL or ≥ 25% increase in baseline value within 72 h of contrast agent administration). Secondary outcomes included adverse events at 30 days. Patient follow-up: 93% at 30 days.
Main results Time from randomization (and study drug administration) to contrast medium administration ranged from 15 to 44 hours. Rosuvastatin reduced risk for CI-AKI more than control (Table); in planned subgroup comparisons, CI-AKI did not differ by presence of diabetes (P = 0.49 for interaction) or by baseline estimated creatinine clearance (< 60 mL/min vs ≥ 60 mL/min) (P = 0.79 for interaction). Compared with the control group, the rosuvastatin group was less likely to have adverse cardiovascular or renal events at 30 days (3.6% vs 7.9%, P = 0.036). Early high-dose rosuvastatin vs control in patients with non–ST-elevation acute coronary syndrome having an early invasive strategy‡
CI-AKI at 72 h§
Event rate Rosuvastatin Control 6.7%
Source of funding: Centro Cardiopatici Toscani. For correspondence: Dr. A. Toso, Misericordia e Dolce Hospital, Prato, Italy. E-mail [email protected]. ■
Commentary
Blinding: Unblinded.†
Outcome
†See Glossary.
15%
RRR (95% CI)
NNT (CI)
58% (26 to 77)
12 (9 to 26)
‡CI-AKI = contrast-induced acute kidney injury; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rate and adjusted odds ratio in article.
CI-AKI is common after coronary angiography. The finding of a beneficial effect of rosuvastatin in reducing CI-AKI in the Italian trial by Leoncini and colleagues is not consistent with all previous trials (1). However, the result does align with 3 other trials, including the trial from Han and colleagues of almost 3000 patients recruited from 53 centers in China (1, 2). Inconsistent results across published trials may relate to methodology, including small sample sizes, open-label design, and differing definitions of CI-AKI. The type of statin may also be important; Leoncini and colleagues and Han and colleagues (2) tested rosuvastatin (a hydrophilic statin), whereas other trials tested simvastatin and atorvastatin (hydrophobic statins). Current American College of Cardiology/American Heart Association guidelines recommend statin initiation before discharge after an admission for a NSTE-ACS. Given the growing evidence that statins given before, rather than after, angiography reduce renal and cardiovascular events (2, 3), it seems reasonable to recommend high-dose rosuvastatin before angiography; patients could be switched to another statin at discharge if desired. Current evidence suggests that the potential harms of such an approach would be minimal. It may also be useful to clarify the benefit–risk profile of preangiography rosuvastatin in subpopulations with advanced chronic kidney disease, ejection fraction < 30%, or a very high CI-AKI risk score. Such patients were excluded or participated in small numbers in the trials by Leoncini and colleagues and Han and colleagues (2). Amber O. Molnar, MD University of Ottawa Ottawa, Ontario, Canada Amit X. Garg, MD Western University London, Ontario, Canada References 1. Mao S, Huang S. Ren Fail. 2014 Feb 6. [Epub ahead of print] 2. Han Y, Zhu G, Han L, et al. J Am Coll Cardiol. 2014;63:62-70. 3. Benjo AM, El-Hayek GE, Messerli F, et al. Catheter Cardiovasc Interv. 2013. [Epub ahead of print]
§Serum creatinine ≥ 0.5 mg/dL or ≥ 25% increase in baseline value within 72 h of contrast agent administration.
20 May 2014 | ACP Journal Club | Volume 160 • Number 10
© 2014 American College of Physicians
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/930210/ by a NYU Medical Center Library User on 03/20/2017
JC9
