Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: Results of a prospective, multicenter, randomized trial,☆☆,,★★,

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Abstract

A group of 460 patients was considered in our prospective study of assessment of the efficiency and safety of 6F (internal diameter 0.062 inches) guiding catheters to perform elective percutaneous coronary angioplasty by the femoral approach by using conventional balloon systems. The patients were randomly assigned either a 6F guiding catheter (first group, n = 231; 247 coronary lesions), or a 7F or 8F guiding catheter (second group, n = 229; 252 coronary lesions). The exclusion criteria were the ongoing myocardial infarction, the marked reduction of left ventricular function, and the decision to treat the lesion with a device not fitting the 6F guiding catheter. The angioplasty success rates (87% in the 6F group vs 88% in the 7F or 8F group) and the stent implantation rates (21% vs 25%) were similar in both groups. The ischemic complication rates (death, 2 vs 1) were also similar. The incidence of the femoral complications was significantly less important in the 6F group than in the 7/8F group (13.8% vs 23.5% p < 0.01). Significant differences also were noted for the procedural time (36 ± 22 vs 41 ± 28 min; p < 0.01), the fluoroscopy time (11 ± 10 vs 14 ± 4 min; p < 0.05), the volume of contrast injected (136 ± 68 ml vs 168 ± 95 ml; p < 0.0001), and the time of femoral compression after the introducer sheath removal (11.7 ± 9 vs 14.1 ± 12 min; p < 0.01). Our data suggest that 6F guiding catheters for elective coronary angioplasty are more effective than are the larger diameter catheters. Besides a significant decrease of vascular complications, angioplasty with a 6F guiding catheter reduces the procedural time and the amount of contrast. (Am Heart J 1997;134:131-137.)

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.

References (24)

  • P Meyer et al.

    Angioplastie transluminale coronaire avec des cathéters-guides 6 french: etude préliminaire de faisabilité

    Arch Mal Coeur

    (1994)
  • D Metz et al.

    Evaluation de l’utilisation systématique de catheters guides 6 French large lumiére en angioplastie coronaire conventionnelle

    Arch Mal Coeur

    (1995)
  • Cited by (0)

    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.

    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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