Two recent studies have highlighted the probable beneficial effects of statins, in particular atorvastatin, when used in patients undergoing percutaneous coronary intervention (PCI).  The Novel Approaches for Preventing or Limiting Events Trial II (NAPLES II) and Atorvastatin for Reduction of Myocardial Damage During Angioplasty-Acute Coronary Syndromes (ARMYDA-RECAPTURE) are discussed here.

 

The ARMYDA-RECAPTURE study was recently been published in the Journal of the American College of Cardiology(1).  The aim was to see if patients who were already receiving statin therapy would benefit from an acute reloading dose before undergoing percutaneous coronary intervention (PCI).  In particular the trial was designed to look at the affects on the rates of peri-procedural myocardial infarction (MI).

 

Peri-procedural MI was defined as CK-MB elevation >3 times the upper limit of normal or associated chest pain or ST/T wave changes.  Patients undergoing PCI either had stable angina or a non-ST elevation MI and all were receiving statin therapy.  Atorvastatin re-load was given as 80mg 12 hours before procedure then 40mg pre procedure.  383 patients were included in total, 192 received atorvastatin and 191 placebo.  After the PCI all patients were prescribed atorvastatin 40mg long term.  The primary outcome was major adverse cardiac events (cardiac death, MI and target vessel revascularisation) at 30 days and the secondary outcome was peri-procedural MI, defined as CK-MB elevation >3 times the upper limit of normal or associated chest pain or ST/T wave changes.

 

Major adverse events in the atorvastatin group was 3.4% versus 9.1% in the placebo group (P=0.045).  In the atorvastatin group 13% of patients had a peri-procedural MI based on CK-MB rise and this compared with 23% in the placebo group (P=0.023). In the atorvastatin group 36% of patients had a rise in Troponin I three times the upper limit of normal, compared with 47% in the placebo group (P=<0.032).The results showed that the rate of major adverse cardiovascular events was lower at 30 days in the atorvastatin re-load group.  There was a significant reduction in peri-procedural MI.  The main benefit from atorvastatin re-load is in the non ST segment MI group and is seen the most with reduction in peri-procedural MI.

 

This trial included small numbers and larger trials are needed before re-loading becomes routine practice.

 

The NAPLES II trial was also recently been published in the Journal of the American College of Cardiology(2).  It sought to evaluate the benefits of administering high dose atorvastatin 80mg to patients undergoing elective PCI on the rates of peri-procedural MI.  This time, in comparison to ARMYDA-RECAPTURE, the patients were not already taking a statin prior to their procedure.  Atorvastatin was given as a single one off loading dose within 24 hours of the procedure.  This trial was designed to see if patients who were not on a statin had any benefit from a one off loading dose to reduce the incidence of peri-procedural MI. 

 

As with ARMYDA-RECAPTURE, peri-procedural MI was defined as CK-MB elevation >3 times the upper limit of normal or associated chest pain or ST/T wave changes.  668 patients who were not taking a statin were included and 338 randomised to the atorvastatin 80mg group and 330 to the placebo group.  CK-MB and Troponin I was measured before the PCI and at six and 12 hours.

 

In the atorvastatin group 9.5% of patients had a peri-procedural MI based on CK-MB rise and this compared with 15.8% in the placebo group (P=0.014). In the atorvastatin group 26% of patients had a rise in Troponin I three times the upper limit of normal, compared with 39.1% in the placebo group (P=<0.001).

 

This is a relatively small study that was not blinded therefore larger scale studies are needed.  Also the use of IIb/IIIa inhibitors and beta-blockers was not randomised which could also have affected the results.

 

These two recent trials show evidence is mounting for the use of statins pre PCI, even if the patient is already on a statin.  As discussed above, both trials involved small numbers and larger trials are needed before re-loading becomes routine.  It does seem prudent that statin naive patients are given high dose statins pre PCI in ACS, which is probably always the case anyway, as statins are routinely prescribed on admission in ACS patients.  These results may be due to the pleiotropic effects, in particular the anti-inflammatory affects, of statins.

 

 

1.         Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol2009;54(6):558-65. Epub 2009 Jul 2.

2.         Briguori C, Visconti G, Focaccio A, Golia B, Chieffo A, Castelli A, et al. Novel approaches for preventing or limiting events (Naples) II trial: impact of a single high loading dose of atorvastatin on periprocedural myocardial infarction. J Am Coll Cardiol2009;54(23):2157-63. Epub 009 Aug 6.