European Heart Journal Advance Access originally published online on August 31, 2007
European Heart Journal 2007 28(19):2418; doi:10.1093/eurheartj/ehm332
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Comment on the ‘pilot’ GRACIA-2 randomized trial: reply
Servicio de Cardiología
Hospital General Universitario Gregorio
Marañón
Doctor Esquerdo 46
28007 Madrid
Spain
Servicio de Cardiología
Hospital General Universitario Gregorio
Marañón
Doctor Esquerdo 46
28007 Madrid
Spain
E-mail address: faviles{at}secardiologia.es
We thank Dr Villata et al. for their thought-provoking comments. Their concern about the suitableness to choose combined endpoints in clinical trials deserves some comment.
First of all, if the main advantage of randomized trials, as the GRACIA-2, is that the randomization procedure helps prevent selection bias, we would agree to argue that the lower prevalence of three vessel disease found in the early routine post-fibrinolysis angioplasty group could depend on early lysis of thrombus, more than on an underlying selection bias. Thus, for clarity, significant coronary artery stenosis was considered present when 50% diameter stenosis of at least one major coronary artery was observed.
Secondly, Dr Villata et al. should keep in mind that our study was specifically designed using surrogate endpoints and no clinical endpoints. Surrogate variables to predict mortality may be gathered in a shorter timeframe or evaluated with higher confidence and leads to a reduction in the sample size. Thus, the sample size calculation of 2500 patients provided by Dr Villata et al., in their letter is misleading as it is based on the combine clinical data resulted in the trial (Table 4), but not in the surrogate endpoints evaluated in our study.1
Finally, we are also convinced that individual clinical hard endpoints do better evaluate the benefit of a reperfusion strategy instead of combine clinical endpoints. However, the numbers of patients proposed by Dr Villata et al., (i.e. 41 021) would make independent research as ours financially and logistically impossible. Following Dr Villata's example, the GRACIA-2 would never exist.
Reference
- Fernandez-Aviles F, Alonso JJ, Pena G, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Moreu J, Hernandez RA, Castro-Beiras A, Gabriel R, Gibson CM, Sanchez PL. GRACIA-2 (Groupo de Analisis de Cardiopatia Isquemica Aguda) Investigators. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J (2007) 28:949–960.
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