Clinical Investigation
Interventional Cardiology
N-acetylcysteine versus AScorbic acid for Preventing contrast-Induced nephropathy in patients with renal insufficiency undergoing coronary angiography: NASPI study—a prospective randomized controlled trial

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Background

Contrast-induced nephropathy (CIN) is a leading cause of hospital-acquired renal failure and affects mortality and morbidity. There has been no study comparing the efficacy of N-acetylcysteine (NAC) and ascorbic acid that have potential for CIN prevention in patients with renal insufficiency.

Methods

We conducted a prospective randomized controlled trial. A total of 212 patients who had pre-existing renal impairment with basal creatinine clearance ≤60 mL/min and/or serum creatinine (SCr) level of ≥1.1 mg/dL, were randomized to have either high-dose NAC (1,200 mg orally twice a day before and on the day of coronary catheterization, n = 106) or ascorbic acid (3 g and 2 g orally before, and 2 g twice after coronary catheterization with a 12-hour interval, n = 106). The primary end point was the maximum increase of SCr level, and the secondary end point was the incidence of CIN.

Results

The maximum increase of SCr level was significantly lower in NAC group than in ascorbic acid group as follows: −0.03 ± 0.18 mg/dL versus 0.04 ± 0.20 mg/mL, respectively (P = .026). Patients with diabetes or who had received a high dose of contrast media experienced significantly less rise of SCr level with NAC than ascorbic acid; in diabetic subgroup, −0.05 ± 0.22 mg/dL versus 0.09 ± 0.29 mg/mL, respectively (P = .020); in patients with high dose of dye, −0.03 ± 0.17 mg/dL versus 0.04 ± 0.21 mg/mL, respectively (P = .032). The incidence of CIN, the secondary end point, tended to be in favor of NAC rather than ascorbic acid, 1.2% versus 4.4%, respectively (P = .370). Notably, among the diabetes patients, the NAC significantly lowered CIN rate than ascorbic acid, 0% (0/38) versus 12.5% (4/32), respectively (P = .039).

Conclusion

High-dose NAC seems more beneficial than ascorbic acid in preventing contrast-induced renal function deterioration in patients, especially diabetic patients, with renal insufficiency undergoing coronary angiography.

Section snippets

Patient population

The NASPI (N-Acetylcysteine vs Ascorbic Acid for Preventing Contrast-Induced Nephropathy in Patients with Renal Insufficiency Undergoing Coronary Angiography) trial was conducted in 2 national university hospitals in Korea, Seoul National University Hospital, Seoul, Korea, and Seoul National University Bundang Hospital, Gyeonggi-do, Korea. From February 2005 to January 2006, a total of 3,080 patients referred for coronary catheterization and/or coronary intervention were screened for

Patient demographics and disposition

A total of 3,080 patients referred for coronary angiography and/or intervention were screened between February 2005 and January 2006 (Figure 1). Of these patients, 490 met the inclusion criteria based on a basal CrCl ≤60 mL/min and/or an SCr level ≥1.1 mg/dL. Two hundred forty-seven patients who did not take statin in this selected group were enrolled in another concurrent clinical study (PROMISS trial), whereas after excluding 29 patients who declined consent to participate and 2 who were on

Discussion

This NASPI study, for the first time, compared the 2 well-known antioxidants NAC and ascorbic acid for their relative efficacy in preventing CIN and showed that high-dose NAC was associated with less increment of SCr level and trended toward lower rate of CIN rather than ascorbic acid.

In modern clinical practice, the characteristic demographic change is a growing elderly population, often patients with cardiovascular and renal comorbidities. Such change is associated with a greater number of

Conclusion

In conclusion, high-dose NAC seems more beneficial than ascorbic acid for preventing CIN in patients with pre-existing renal insufficiency undergoing coronary angiography. This efficacy was more pronounced in higher risk patients such as those with diabetes.

Disclosures

The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.

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    • Cited by (0)

    Clinical Trial Identifier: NCT00356954.

    This study was supported by a grant from the Innovative Research Institute for Cell Therapy (IRICT: A062260), Republic of Korea, and Clinical Research Center for Ischemic Heart Disease sponsored by the Ministry of Health and Welfare, Republic of Korea (0412-CR02-0704-0001).

    1

    The affiliation of the first author has changed from Seoul National University Hospital to Hallym University Sacred Heart Hospital since this work was completed.

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