European Heart Journal Advance Access originally published online on January 7, 2005
European Heart Journal 2005 26(4):417; doi:10.1093/eurheartj/ehi085
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Statins and percutaneous coronary intervention
Interventional Cardiology Unit
San Filippo Neri Hospital,
Rome, Italy
Tel: +39 0633062481
Fax: +39 0633062516
E-mail address: vpasceri{at}hotmail.com
Department of Cardiovascular Sciences,
Campus Bio-Medico University,
Rome, Italy
Department of Cardiovascular Sciences,
Campus Bio-Medico University,
Rome, Italy
On behalf of the ARMYDA Investigators
We have read with interest the article by Briguori et al.1 and we have several comments for the authors. The paper is a randomized study on pre-treatment with statins before percutaneous intervention, showing reduction of post-procedural myocardial infarction (MI). The ARMYDA (Atorvastatin for Reduction of Myocardial Damage during Angioplasty) trial,2 was recently published and, by highlighting the differences between the two studies, we would like to point out some flaws in the paper by Briguori et al.
ARMYDA was the first randomized, prospective, multi-centre, double-blind, placebo-controlled trial, in which a fixed dose (40 mg) of a specific drug (atorvastatin) was given for a well-defined period (7 days) before elective intervention in a selected patient population with the same clinical syndrome (stable angina). The diagnosis of peri-procedural MI was made according to the Joint ESC/ACC Committee definition of MI for clinical trials on Percutaneous Intervention3 (i.e. CK-MB >2 times above the upper normal limit). This protocol allowed the detection of a significantly lower occurrence of peri-procedural MI in the atorvastatin arm, with an average risk reduction of 80% at multivariate analysis.
Conversely, Briguori's study used a multitude of different statins (atorvastatin, pravastatin, simvastatin, and fluvastatin) at variable doses, given for variable times before the procedure (between 3 and 31 days), and left to the physician's discretion; thus, it is not clear how the prospective randomization protocol was ‘designed’, in particular which drug treatment was specifically being investigated. This is quite unusual for a clinical randomized trial.
In Briguori's study, a significant difference in peri-procedural MIs was found only for those with CK-MB >5 times above the upper normal limit, and there was no attempt to analyse the data according to the Joint ESC/ACC guidelines indicated above. Moreover, the incidence of such large MIs was remarkably higher in Briguori's study vs. ARMYDA (16 vs. 5% in the untreated arm, 8 vs. 0% in the treated arm): the reason for this is also unclear.
Finally, the sizable procedural complications rate (9 vs. 0% in ARMYDA) reported by Briguori, somewhat unusual in a stable elective patient population, makes the incidence of unexplained peri-procedural MIs, and the potential impact of a structured protective pharmacological intervention, difficult to evaluate in such study.
References
- Briguori C, Colombo A, Airoldi F et al. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J 2004;25:1822–1828.
[Abstract/Free Full Text] - Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention. Results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) Study. Circulation 2004;110:674–678.
[Abstract/Free Full Text] - Alpert JS, Thygesen K, Antaman E et al. Myocardial infarction redefined: a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. J Am Coll Cardiol 2000;36:959–969.
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