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Early High-Dose Rosuvastatin Does Not Provide Myocardial Protection in NSTE-ACS

By Yael L. Maxwell

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Early high-dose rosuvastatin does not add any cardioprotective effect in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) receiving high-dose clopidogrel, according to a subanalysis of the PRATO-ACS trial published online August 10, 2014, ahead of print in the American Heart Journal. 

Methods
 The main PRATO-ACS study, which randomized 504 NSTE-ACS patients to high-dose clopidogrel with (n = 225) or without (n = 225) rosuvastatin (40 mg on admission and 20 mg/day until discharge), found that the statin helped to reduce contrast-induced nephropathy. All patients in the study, published in the Journal of the American College of Cardiology in January 2014, were statin-naive and received iodixanol as the contrast agent prior to imaging.
For the substudy, Anna Toso, MD, of Santo Stefano Hospital (Prato, Italy), and colleagues looked at cardiac biomarkers to determine the cardioprotective effects of the statin.


No Difference in Cardiac Biomarkers

The study and control groups had similar median values for peak cardiac troponin I (primary endpoint) and CK-MB during the index event, regardless of whether or not patients eventually were treated with PCI (n = 333; table 1).

Table 1. Median Peak Cardiac Biomarkers During Index Event

 

Statin

Control

P Value

Overall

    Troponin I, ng/mL

    CK-MB, ng/mL

 

3.8

17.5

 

3.5

16.8

 

.60

.64

PCI-Treated

    Troponin I, ng/mL

    CK-MB, ng/mL

 

4.9

20

 

4.2

22

 

.72

.73 


Moreover, no differences were found in either cardiac biomarker at any time point throughout the study. 

Among the PCI-treated patients, there were no differences in periprocedural MI (according to SCAI definition based on CK-MB) between the statin and control groups (4.7% vs 4.3%; P = .87).

The rate of death or nonfatal MI was 5.4% (n = 27) at 6 months, with two-thirds of events occurring in PCI patients. Overall, patients who received rosuvastatin tended to have lower cumulative rates of death and nonfatal MI than those who did not (3.6% vs 7.2%; P = .07). The benefit was clearly seen in those treated with PCI (2.9% vs 8%;; P = .048).

Mechanisms of Benefit Unclear

“The adjunctive treatment with high-dose rosuvastatin administered early on-admission does not appear to influence myocardial necrosis marker release during the index hospitalization,” Dr. Toso and colleagues write.

While the study confirms statins’ ability to improve short-term clinical outcomes, they note, “the exact mechanisms by which statins produce such clinical benefits remain unclarified.” 

The lack of protection against myocardial damage, the authors explain, “could be related to the high dose of clopidogrel administered on admission (loading dose 600 mg) and during hospitalization (maintenance dose 150 mg),” which may have masked any added benefit from statins. 

Additionally, the authors say, since most patients (92%) presented with increased baseline levels of cardiac biomarkers compared to other study groups, “it may be more difficult to individuate specific cardioprotective effects of statins evidenced instead in studies on lower risk patients (only 10-30% with elevated biomarkers).”

 

Source:
Leoncini M, Toso A, Maioli M, et al. Early high-dose rosuvastatin and cardioprotection in the PRATO-ACS study. Am Heart J. 2014;Epub ahead of print.

 

Disclosures:

 

  • Dr. Toso reports no relevant conflicts of interest.

 

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