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Preventive effect of pretreatment with intravenous nicorandil on contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography (PRINCIPLE Study).

ABSTRACT: To investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy (CIN) in patients with renal dysfunction undergoing coronary angiography.This randomized controlled multicenter study enrolled a total of 166 patients (nicorandil n=81; control n=85) with an estimated glomerular filtration rate <60 mL/min. Nicorandil 12 mg dissolved in 100 mL of 0.9% saline was administered intravenously for 30 minutes just prior to coronary angiography in the nicorandil group. The same volume of only saline was given to the control group. The primary endpoint was the incidence of CIN, defined as >0.5 mg/dL increase or >25% rise in serum creatinine (SCr) concentration within 48 hours of contrast exposure compared to baseline.The final analysis included 149 patients (nicorandil n=73; control n=76). The baseline characteristics and the total volume of the used contrast (Iodixanol, 125.6±69.1 mL vs. 126.9±74.6 mL, p=0.916) were similar between the two groups. The incidence of CIN also did not differ between the nicorandil and control groups (6.8% vs. 6.6%, p=0.794). There was no difference between the two groups in the relative change in SCr from baseline to peak level within 48 hours after coronary angiography (-1.58±24.07% vs. 0.96±17.49%, p=0.464), although the nicorandil group showed less absolute change in SCr than the control group (-0.01±0.43 mg/mL vs. 0.02±0.31 mg/mL, p=0.005).Prophylactic intravenous infusion of nicorandil did not decrease the incidence of CIN in patients with renal dysfunction undergoing coronary angiography.

SUBMITTER: Ko YG

PROVIDER: S-EPMC3663233 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Preventive effect of pretreatment with intravenous nicorandil on contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography (PRINCIPLE Study).

Ko Young-Guk YG Lee Byoung-Kwon BK Kang Woong Chol WC Moon Jae-Youn JY Cho Yun Hyeong YH Choi Seong Hun SH Hong Myeong-Ki MK Jang Yangsoo Y Kim Jong-Youn JY Min Pil-Ki PK Kwon Hyuck-Moon HM

Yonsei medical journal 20130701 4

<h4>Purpose</h4>To investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy (CIN) in patients with renal dysfunction undergoing coronary angiography.<h4>Materials and methods</h4>This randomized controlled multicenter study enrolled a total of 166 patients (nicorandil n=81; control n=85) with an estimated glomerular filtration rate <60 mL/min. Nicorandil 12 mg dissolved in 100 mL of 0.9% saline was administered intravenously for 30 minut ...[more]

PMID: 23709432

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Project description:PurposeTo determine the causal association and effect of intravenous iodinated contrast material exposure on the incidence of acute kidney injury (AKI), also known as contrast material-induced nephropathy (CIN).Materials and methodsThis retrospective study was approved by an institutional review board and was HIPAA compliant. Informed consent was waived. All contrast material-enhanced (contrast group) and unenhanced (noncontrast group) abdominal, pelvic, and thoracic CT scans from 2000 to 2010 were identified at a single facility. Scan recipients were sorted into low- (<1.5 mg/dL), medium- (1.5-2.0 mg/dL), and high-risk (>2.0 mg/dL) subgroups of presumed risk for CIN by using baseline serum creatinine (SCr) level. The incidence of AKI (SCr ≥ 0.5 mg/dL above baseline) was compared between contrast and noncontrast groups after propensity score adjustment by stratification, 1:1 matching, inverse weighting, and weighting by the odds methods to reduce intergroup selection bias. Counterfactual analysis was used to evaluate the causal relation between contrast material exposure and AKI by evaluating patients who underwent contrast-enhanced and unenhanced CT scans during the study period with the McNemar test.ResultsA total of 157,140 scans among 53,439 unique patients associated with 1,510,001 SCr values were identified. AKI risk was not significantly different between contrast and noncontrast groups in any risk subgroup after propensity score adjustment by using reported risk factors of CIN (low risk: odds ratio [OR], 0.93; 95% confidence interval [CI]: 0.76, 1.13; P = .47; medium risk: odds ratio, 0.97; 95% CI: 0.81, 1.16; P = .76; high risk: OR, 0.91; 95% CI: 0.66, 1.24; P = .58). Counterfactual analysis revealed no significant difference in AKI incidence between enhanced and unenhanced CT scans in the same patient (McNemar test: χ(2) = 0.63, P = .43) (OR = 0.92; 95% CI: 0.75, 1.13; P = .46).ConclusionFollowing adjustment for presumed risk factors, the incidence of CIN was not significantly different from contrast material-independent AKI. These two phenomena were clinically indistinguishable with established SCr-defined criteria, suggesting that intravenous iodinated contrast media may not be the causative agent in diminished renal function after contrast material administration.Supplemental materialhttp://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12121823/-/DC1.

Project description:BackgroundThe excess volume of contrast media (CM) is a marker of a more severe coronary culprit lesion and longer intervention duration in patients undergoing cardiac procedures. However, it is unclear whether the contrast volume is directly correlated with worse clinical outcomes. The aim of this study was to investigate the association between contrast dose and the incidence of 1-year major adverse cardiac and cerebrovascular events (MACCE) and all-cause bleeding events in patients undergoing cardiac catheterization and coronary angiography (CAG).MethodsWe prospectively enrolled 10,961 consecutive patients diagnosed with coronary heart disease expecting CAG from 2012 to 2013. The study population was pursued with a follow-up duration of 1 year. The predictive value of contrast volume, divided into quartiles, for the risk of MACCE and all-cause bleeding events was assessed using logistic regression analysis.ResultsThe cumulative incidence of 1-year MACCE was 8.65%, which was directly associated with increasing contrast volume. In particular, MACCE was observed in 7.16%, 7.89%, 9.31%, and 11.73% of cases in the contrast volume quartile Q1 (≤100 ml), Q2 (101-140 ml), Q3 (141-200 ml), and Q4 (>200 ml), respectively (P < 0.001). Moreover, the incidence of 1-year all-cause bleeding events was noted in 4.70%, 5.93%, 7.28%, and 8.21% of patients in Q1, Q2, Q3, and Q4, respectively (P < 0.001). The survival analysis showed that the 1-year MACCE rate was higher in patients using greater CM volume during the CAG. CM volume used >140 ml was associated with the occurrence of 1-year MACCE, and the incidence was dramatically elevated in patients exceeding a contrast volume of 200 ml (P = 0.007).ConclusionOur data suggested that higher contrast volume was significantly correlated with an increased risk of MACCE and all-cause bleeding events in patients undergoing cardiac catheterization.Trial registrationClinicalTrials.gov, NCT01735305; https://clinicaltrials.gov/ct2/show/NCT01735305?id=NCT017353057rank=1.

Dataset Information

Preventive effect of pretreatment with intravenous nicorandil on contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography (PRINCIPLE Study).

Publications

Preventive effect of pretreatment with intravenous nicorandil on contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography (PRINCIPLE Study).

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