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Percutaneous Coronary Intervention With Off-Site Cardiac Surgical Backup

2008; Elsevier BV; Volume: 101; Issue: 10 Linguagem: Inglês

10.1016/j.amjcard.2008.03.018

1879-1913

Menko‐Jan de Boer, Jean G.F. Bronzwaer, Maarten Boers,

Cardiac and Coronary Surgery Techniques

As members of the Steering Committee in a part of the study reported by Peels et al 1 Peels H.O. de Swart H. Ploeg T. Hautvast R.W. Cornel J.H. Arnold A.E. Wharton T.P. Umans V.A. Percutaneous coronary intervention with off-site cardiac backup for acute myocardial infarction as a strategy to reduce door-to-balloon time. Am J Cardiol. 2007; 100: 1353-1358 Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar on the issue of percutaneous intervention without on-site cardiac surgery backup for acute myocardial infarction, we would like to point out that their report lacks crucial information. At first sight, the investigators must be congratulated on their results, especially with regard to reduction of door-to balloon time. However, the issue of safety remains unaddressed, because only 199 patients were randomized, from October 2002 to November 2003, to primary angioplasty at a local center without on-site cardiosurgical facilities or a tertiary center with on-site cardiac surgery. The sample size was simply too small to detect a clinically relevant difference between the 2 groups. For instance, mortality of 8% compared with 3% in either group would not have resulted in a statistically significant difference, which is a classic β error. As such, the difference in final diameter stenosis <50% and Thrombolysis in Myocardial Infarction grade 3 flow is erroneously reported as significant: the p value should be 0.20, not 0.02 (Table 2). In Table 3, the Peels et al present only the angiographic results, but the key findings of the efficacy end points and events at 30 days are not reported for the on-site center. Also, no data are provided on the patients not randomized, so we are not informed on the representativeness of the included population.