European Heart Journal Advance Access originally published online on June 15, 2005
European Heart Journal 2005 26(15):1567-1568; doi:10.1093/eurheartj/ehi359
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DECOPI (DEsobstruction COronaire en Post-Infarctus): a randomized multi-centre trial of occluded artery angioplasty after acute myocardial infarction: DECOPI or NOT DECOPI: more smoke on the horizon: reply
Department of Cardiology
Hôpital Bichat
AP-HP
46 rue Henri Huchard
75877 Paris Cedex 18
France
E-mail address:
gabriel.steg{at}bch.ap-hop-paris.fr
Departments of Biostatistics and Medical
Information
Hôpital St Louis
AP-HP, Paris
Department of Cardiology
Hôpital Fontenoy
Chartres
France
We agree with Dr Achrafi that DECOPI, although the largest trial so far to address ‘the open artery hypothesis’, suffers from limitations, mainly related to its limited size and low risk population, as delineated in our paper.1 We concur in hoping that the ongoing OAT trial will bring a clear answer to this question, as stated in our conclusion. With respect to the other comments, we respectfully disagree:
- Lack of risk-adjusted analyses: we believe this was not warranted as there was no imbalance in the baseline characteristics between randomly assigned groups. Another reason for adjusting is to increase the precision with which the treatment effect is estimated, but this is only relevant to normal regression models and not to the Cox model used in this study.2
- We used a composite outcome measure including mortality as the primary endpoint, as the compared treatments were expected to impact mortality and major morbidity, resulting in an increased power when compared with mortality alone. As recommended by the ICH harmonized tripartite guideline, the outcomes that contributed to the composite outcome were associated with the primary objective of the trial, and the components of the composite outcome were defined as secondary outcomes and reported alongside the results of the primary analysis in a table. As no difference was observed for any endpoint, adjustment for multiplicity would have not modified the conclusions of the trial.
- Using a secondary endpoint combining the primary endpoint and admission for heart failure has not ‘created a shadow of uncertainty’ but is a standard procedure in trials ascertaining the benefit of interventions in heart failure. In addition, all admissions were validated by a critical event committee.
- Length of the study: although we agree that, in principle, it would be ideal to have long-term follow-up, 34 months duration as in DECOPI, it is expected to offset any initial risks related to early harm from the procedure.
- Absence of coronary angiography beyond 6 months: in our study, all the patients underwent a baseline angiogram and a repeat angiogram at 6 months. We believe that it would be difficult to justify a third coronary angiogram, especially if the trial is powered on clinical outcomes.
- We are thankful to Dr Achrafi for reminding us of the importance of myocardial perfusion as opposed to epicardial coronary revascularization in assessing the outcome of percutaneous coronary intervention in the setting of acute myocardial infarction,3 but we fail to understand the point of myocardial contrast echocardiography or intracoronary Doppler flow velocity mapping in a clinical outcomes trial.
- Finally, Dr Achrafi recommends substituting left ventricular ejection fraction with other measures which he believes are better correlated to survival, some of which are unfamiliar to us. However, left ventricular ejection fraction remains a simple, clinically meaningful index, highly correlated to long-term outcomes in the post-myocardial infarction setting.
Although we welcome scientific discussion and open criticism, we must also disagree with the concept that DECOPI brought ‘more smoke on the horizon’. On the contrary, we believe that the ultimate truth in science is often reached through progressive reduction in uncertainty brought by cumulative evidence from multiple trials.
References
- Steg PG, Thuaire C, Himbert D, Carrié D, Champagne S, Coisne D, Khalifé K, Cazaux P, Logeart D, Slama M, Spaulding C, Cohen A, Tirouvanziam A, Montély JM, Rodriguez RM, Garbarz E, Wijns W, Durand-Zaleski I, Porcher R, Brucker L, Chevret S, Chastang C on behalf of the DECOPI Investigators. DECOPI (DEsobstruction COronaire en Post-Infarctus): a randomized multi-centre trial of occluded artery angioplasty after acute myocardial infarction. Eur Heart J 2004;25:2187–2194.
[Abstract/Free Full Text] - Armitage P, Colton T. Encyclopedia of Biostatistics. Chichester: Wiley and Sons; 1998.
- Steg PG, Karila-Cohen D. A paradigm shift for acute myocardial infarction: from coronary patency to myocardial reperfusion. Eur Heart J 1998;19:1282–1286.
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