Michigan Registry Study Finds Pre-PCI Statin Use Not Associated with Better Outcomes

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A substantial number of patients do not receive statins before percutaneous coronary intervention (PCI) but appear to suffer no consequences in terms of major in-hospital events or long-term mortality, according to an article published online April 7, 2014, ahead of print in the American Heart Journal.

Currently, ACC/AHA guidelines state that “administration of a high-dose statin is reasonable before PCI to reduce the risk of periprocedural MI.”

Researchers led by Hitinder S. Gurm, MD, of the University of Michigan Medical Center (Ann Arbor, MI), analyzed data on statin use and outcomes for 80,493 nonemergent PCI patients from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry, spanning 44 centers, between January 2010 and December 2012.

Pretreatment Has No Effect on Outcomes

Overall, 33.0% of patients (n = 26,547) did not receive statins within 24 hours prior to PCI. Patients without pre-PCI statin administration experienced higher unadjusted rates of transfusion, in-hospital mortality, and CABG than their counterparts.

In a propensity-matched analysis of 16,235 patient pairs, there were no differences in in-hospital mortality or periprocedural MI (ECG changes or cardiac biomarker elevation to more than 3 times upper normal limit in patients with normal preprocedural biomarkers) between the 2 groups. Furthermore, rates of stroke, CABG, CIN (increase in serum creatinine of ≥ 0.5 mg/dL postprocedure), and transfusion were comparable between groups (table 1).

Table 1. Propensity-Matched Analysis: In-hospital Outcomes

 

Pre-PCI Statin
(n =16,235)

No Pre-PCI Statin
(n = 16,235)

P Value

Death

0.42%

0.43%

0.98

MI

2.10%

2.34%

0.11

CABG

0.55%

0.71%

0.19

Stroke

0.20%

0.20%

1.000

CIN

1.85%

1.88%

0.74

Transfusion

2.49%

2.65%

0.26

 
Results were maintained across prespecified subgroups of CAD presentation including NSTEMI and stable CAD.

In 2,870 patients with pre-PCI statin use and long-term Medicare follow-up data, multivariable analysis found no difference in mortality at 36 months compared with those who did not receive statins before PCI (HR 1.00; P = 0.96).

Guidelines Not Always Followed

The “key finding,” according to the authors, is the high percentage of “hemodynamically stable patients, without a documented contraindication, [who did] not receive statins prior to undergoing nonemergent PCI despite class II recommendations in the ACC/AHA guidelines for PCI.”

This is unexpected, given that all of the hospitals in the study participate in an “active multicenter quality improvement collaborative,” Dr. Gurm and colleagues note, raising the possibility that “some patients do not receive statins due to the failure to recognize the recommendations for [statin] pretreatment by the medical caregivers.”

Initiation Before PCI Less Important

Lack of pre-PCI statin use was not the only surprising result, according to Dr. Gurm. He told TCTMD in an email that he also “was expecting to see a reduction in CIN (and possibly MI)” with pretreatment.

In fact, the trial outcomes stand in contrast to several observational and randomized trials demonstrating that pre-PCI administration of statins reduces periprocedural adverse events including renal complications and MI compared with both postprocedural and nonuse, the authors write.

However, they explain, of the previous studies showing improved periprocedural and postprocedural benefits with pre-PCI statin administration, “almost all of the randomized trials… used high-dose statins,” whereas the current study examines general clinical practice. Dr. Gurm said he looks forward to the results of the SECURE-PCI trial to help define optimal statin dosage.

Whether or not a statin is initiated before PCI, Dr. Gurm stated, “there is no doubt that statins are an essential element of CAD treatment. I think the important thing is to ensure that a patient who has CAD (irrespective of whether they [undergo] PCI) does not leave the cath lab without a prescription for statins.

“I still think anyone with proven or suspected CAD should be on a statin before undergoing invasive procedures,” he elaborated, “but I cannot make a case anymore that this must happen before the PCI.”

Study Details

At baseline, patients in the pre-PCI statin group were more likely to have previously diagnosed cardiovascular disease and many other risk factors including hypertension, dyslipidemia, and diabetes.

 


Source:
Kenaan M, Seth M, Aronow HD, et al. Pre-procedural statin use in patients undergoing percutaneous coronary intervention. Am Heart J. 2014;Epub ahead of print.

 

 

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Disclosures
  • The BMC2 registry is funded by Blue Cross Blue Shield of Michigan.
  • Dr. Gurm reports receiving research funding from the Agency for Healthcare Research and Quality and the National Institutes of Health.

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