Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: Results of a prospective, multicenter, randomized trial☆,☆☆,★,★★,♢
Section snippets
Patient population and selection criteria
A multicenter cohort of 460 patients was prospectively randomized over a 7-month period between May 1994 and December 1994. The investigators were selected on the basis of their previous experience with 6F, 7F, or 8F guiding catheters (GCs). Only physicians having a prior personal experience of ≥100 6F PTCA procedures were considered for the trial.
Only patients with demonstrated ischemic heart disease with angiographic coronary artery disease or coronary artery bypass grafts deemed suitable for
Results
Clinical and angiographic characteristics of the 460 randomized patients are summarized in Table I, Table II . Coronary angioplasty was attempted in 247 lesions of 231 patients by using a 6F GC and in 252 lesions of 229 patients by using a 7F (85%) or an 8F (15%) GC. There were no differences in gender, mean age, unstable exertional angina, location, or American Heart Association/American College of Cardiology class coronary lesions. Of the angioplasty procedures, 75% were performed immediately
Discussion
Since the introduction of PTCA for treatment of coronary artery disease, angioplasty equipment has been miniaturized. Until then, the combination of low-profile balloon catheters with large inner-lumen 6F GCs was, however, judged a controversial compromise between the procedure effectiveness and the prevention of postprocedural vascular complications, especially when stenting was necessary. The vascular access site may indeed be a site for bleeding complications, because the sheath must be
Acknowledgements
We thank A. Aimonetti, CVT, for excellent logistic support, and thank all the participating catheterization laboratory teams.
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Cited by (0)
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From the Sections of Interventional Cardiology, Hospital Robert Debré, Institut Arnautl Tzanck, Hospital Sud, Clinique St. Vincent, and Clinique Hartmann. A complete list of principal investigators and study coordinators is provided in the appendix.
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Supported in part by Cordis Corporation.
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The authors have no commercial or financial interest in Cordis and had full control of the study protocol design, data analysis, and manuscript preparation.
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Reprint requests: Damien Metz, Service de Cardiologie Hopital Robert Debré, 51092 Reims, France.
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