European Heart Journal Advance Access originally published online on January 7, 2005
European Heart Journal 2005 26(4):417-418; doi:10.1093/eurheartj/ehi086
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Statins and percutaneous coronary intervention: reply
Laboratory of Interventional Cardiology
and Department of Cardiology
Clinica Mediterranea
Via Orazio 2, 80122 Naples, Italy and
Laboratory of Interventional Cardiology
Vita e Salute University School of
Medicine San Raffaele Hospital
Milan, Italy
Tel: +39 081 7259764
Fax: +39 081 7259724
E-mail address: briguori.carlo{at}hsr.it
Laboratory of Interventional Cardiology
Vita e Salute University School of
Medicine San Raffaele Hospital
Milan, Italy
Both our study1 and that by Pasceri et al.2 support the beneficial role of pre-procedural statin administration on lowering the rate of peri-procedural myocardial infarction.
The purpose of our study was to assess in a randomized fashion whether statin treatment, started at least 3 days before stenting, is useful in preventing peri-procedural cardiac enzyme elevation. Our study was not designed to test: (i) a specific statin, (ii) a pre-defined dosage of a specific statin, or (iii) a specific delay between statin administration and the procedure. Statin benefits may be explained not only by their lipid-lowering potential but also by non-lipid-related mechanisms (pleiotropic effects). In our opinion, only with a complete knowledge of the exact mechanism, can one design a study with (i) a specific statin (why atorvastatin?), (ii) a specific dose (why 40 mg?), and (iii) a specific time interval (why 1 week?).
Our study was not blinded. It was not feasible for us to conduct a blind study without support from a sponsor. This fact is a clear limitation overcome by the study of Pasceri et al.
We used the definition of large non-Q-wave myocardial infarction (CK-MB elevation, >5 times ULN) generally considered clinically useful in the field of interventional cardiology, as also reported in the Joint ASC/ASS Committee definition of myocardial infarction for clinical trials of percutaneous intervention.3 The rate of large non-Q-wave myocardial infarction (as defined in our study) reported in the literature is
12%. We reported 15.6% in the control group and 8% in the statin group. The reality is that with a small number of patients, as in the Pasceri study, the percentage of events has large confidence intervals.
We reported an angiographic complication rate of 9% in the statin group and 5% in the control group. This includes the cumulative rate of major/minor dissection, abrupt closure, slow/no reflow, thrombus formation, side branch closure/compromise, and distal embolization. A number of these complications did not have any clinical consequence, still we assumed it was important to highlight their incidence. Pasceri et al. stressed their 0% rate of angiographic complication and had concerns about our unusually high rate of angiographic complication in a stable elective patient population. We would like to point out that the rate of angiographic complication reported in the ESPRIT trial,4 enrolling stable patients undergoing elective stenting was 10.1% in the eptifibatide group and 12.2% in the control group.
References
- Briguori C, Colombo A, Airoldi F et al. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J 2004;25:18221828.
[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 form the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) Study. Circulation 2004;110:674678.
[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;36:959969.
[Free Full Text] - Blankenship JC, Tasissa G, O'Shea C, Iliadis EA et al. Effect of glycoprotein IIb/IIIa receptor inhibition on angiographic complications during percutaneous coronary intervention in the ESPRIT trial. J Am Coll Cardiol 2001;38:653658.
[Abstract/Free Full Text]
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