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J Am Coll Cardiol, 2005; 45:1908-1909, doi:10.1016/j.jacc.2005.03.007 © 2005 by the American College of Cardiology Foundation |
* Interventional Cardiology Section, Beth Israel Deaconess Medical Center, 185 Pilgrim Road, Baker 4, Boston, MA 02215 (Email: dcutlip{at}bidmc.harvard.edu).
These same investigators have published a meta-analysis of 23,230 patients (including ACS [acute coronary syndrome] and vein graft interventions) treated by a mixture of stent, directional coronary atherectomy, and balloon angioplasty over a decade, showing a one-year mortality risk of 3.5% with normal CK-MB, rising to 5.2%, 6.3%, and 10.9% for CK-MB 1 to 3, 3 to 5, and >5 times normal, respectively (2). What such meta-analyses gain in numbers of patients and events may be lost in lack of detail about those patientsfor instance, whether the effect holds true for stenting (as used in 90% of current interventions), and whether it applies equally to incidental CK-MB elevations seen after otherwise successful procedures. Our study is actually one of the largest reports after elective stenting, with nearly 6,000 patients and over 100 death events, and includes data pooled at the patient-by-patient level, so that it could look into the question with greater granularity. The pooling of the trials was fully justified based on the nearly identical inclusion criteria and baseline clinical and angiographic characteristics (3,4). The one-year mortality was similar to other elective stent populations (5) and was essentially flat for normal-to-moderate level CK-MB elevations among successful procedures, whereas mortality was over six times higher in patients with unsuccessful procedures and any elevation in CK-MB.
As we stated in our discussion, the 0.4% absolute difference in mortality between patients with and without myocardial infarction (MI) after successful intervention could still be clinically meaningful. But we must reject the other criticisms of Dr. Ioannidis and colleagues regarding the limitations of our study. The inferences are not based on a small number of unsuccessful procedures, but on an analysis of 5,850 patients with over 100 deaths, for which an unsuccessful procedure was one of the most significant independent predictors of one-year mortality. Most importantly, we are concerned with the misinterpretation of our identification of successful and unsuccessful procedures. We were careful to select unsuccessful procedures using criteria on which most operators would concur in the context of current stenting techniques. We agree many would choose to broaden these criteria and thus further purify the successful group. Regardless of where this line of success is drawn, however, it is clear that the effect of CK-MB elevation among truly successful procedures in this patient cohort would be small to nonexistent.
We also agree that this finding is worth validating in larger numbers of patients. Doing so will require access to databases where the pre-procedure risk and results of successful and unsuccessful procedures are clearly identified, thereby avoiding unnecessary panic among patients and their physicians when small elevations in CK-MB are detected following an otherwise successful procedure.
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