CORRESPONDENCE: LETTER TO THE EDITOR
Reply
George D. Dangas, MD, PhD*
* Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University Medical Center, 161 Fort Washington Avenue, 5th Floor, New York, NY 10032 (Email: GDangas{at}crf.org).
We reviewed carefully the comments of Dr. Chou regarding our recent study (1). A meta-analysis always has several limitations, which we listed in the respective section of our report and which Dr. Chou outlines in his letter. The main issue of the multiple small size, uncontrolled, and often unpublished (as complete papers) studies in the area of vascular closure devices can be attributed to the existence of multiple generations of all devices and to the funding variability (or difficulty to obtain adequate research grants from industry). Similarly, a database analysis (2) is also limited by the uncontrolled, rather random (and certainly nonconsecutive) data entry and the absence of event review and adjudication by an independent committee. Moreover, Dr. Chou’s claim that more recent-generation devices are included is a very reasonable presumption but is not explicitly documented. These limitations of the way the queried database is set up have nothing to do with the elegant way the data were handled by Tavris et al. (2) but still deserve to be outlined.
Therefore, we do not believe that adequate reasons exist to declare one type of analysis "more meaningful" than the other, but we certainly endorse the expressed interest by a major industry stakeholder for a large, randomized study. This is what is needed the most in this subject.
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References
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- Nikolsky E, Mehran R, Halkinm A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures J Am Coll Cardiol 2004;44:1200-1209.[Abstract/Free Full Text]
- Tavris DR, Gallauresi BA, Lin B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender J Invasive Cardiol 2004;16:459-464.[Medline]
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References