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Comparison of 5 French Versus 6 French Guiding Catheters for Transradial Coronary Intervention: A Prospective, Randomized Study
July 2004
The field of interventional cardiology has been blossoming for the past 25 years. Since the performance of the first human percutaneous coronary angioplasty in 1977 by Gruentzig,1 angioplasty equipment has never ceased to improve. Miniaturization of the equipment has been one of the most important hallmarks. It has allowed performance of more complex angioplasty procedures and has also helped reduce peri-procedural complications.
The size of guiding catheters used in percutaneous coronary angioplasty has been dramatically reduced since their introduction. From 9–10 French (Fr) in 1977, the size has gradually decreased, and now percutaneous coronary intervention (PCI) through 6 Fr catheters is well established as an alternative to larger (7 and 8 Fr) catheter size.2–4 However, as there is a constant effort to push the limits of angioplasty a step further, new smaller 5 Fr guiding catheters with large lumens were developed and are now available. Previous small studies have reported the safety of this new device in routine angioplasty.5–7 However, no study has compared the efficacy and safety of the 5 Fr guiding catheter over the standard 6 Fr guiding catheter in PCI.
Smaller guiding catheters are potentially advantageous when the transradial route is favored. Since the lumen diameter of the radial artery is small, the use of a smaller sheath and guiding catheter could lead to less arterial spasm and thereby to less pain and higher procedural success than with a 6 Fr guiding catheter. In addition, we know that the artery diameter to sheath size ratio is an independent predictor of post-procedural radial thrombosis,8,9 and the use of smaller sheaths could help prevent this complication. In the current study, we compared the safety and efficacy of 5 Fr versus 6 Fr guiding catheters for transradial coronary intervention.
Methods
From January 2000 to February 2001, a total of 216 patients were prospectively randomized in the study. The study was performed at 2 different centers (Institut Cardiovasculaire Paris-Sud, Massy, France and Erlangen University Hospital, Erlangen, Germany) and involved 6 different operators with expertise in the transradial procedure. Every patient with a planned transradial PCI was deemed eligible for the study. Clinical exclusion criteria were: acute myocardial infarction; cardiogenic shock; or inability to use the transradial approach. Angiographic exclusion criteria were: anticipated need of angioplasty balloon or stent > 4.0 mm; bifurcation lesions where a double-balloon technique was intended; and planned use of a cutting balloon, rotablator or intravascular ultrasound application. Patients were randomized with a random generator. The study was approved by the institution’s IRBs.
The angioplasty procedure was performed according to operator preference. The 5 Fr Zuma (Medtronic Interventional Vascular, San Diego, California) or Vista Brite Tip (Cordis Corporation, Miami, Florida) guiding catheters, which have an internal lumen of 0.058 in., were used for cases randomized to the 5 Fr group. Sheaths were removed immediately after the procedure. Local hemostasis was obtained by local compression with a radial bracelet.
The primary endpoint of the study was procedural success, defined as a procedure performed via the transradial route, performed with the randomized guiding catheter size, adequate stent delivery when needed, residual stenosis of less than 20% and a final TIMI 3 flow in the targeted artery. Secondary end-points were procedural length (time from the introduction of the guiding catheter in the sheath to the end of the procedure, not including the puncture time), total fluoroscopic time, total amount of dye used during the procedure, angioplasty complications (femoral crossover, failure to deliver stent, inability to use “direct stenting” technique, loss of a stent), and post-procedural radial artery permeability, as assessed by Doppler.
Statistical analysis. The results are expressed as mean values ± standard deviation (SD). Continuous variables were compared with the Fisher’s exact test. Discrete variables were compared with the student’s t-test. A p-value Conclusion. Transradial elective angioplasty using 5 Fr guiding catheters is feasible, but is not associated with any advantages over angioplasty using 6 Fr guiding catheters. Drawbacks of using 5 Fr guiding catheters include the inability to use intravascular ultrasound, atherectomy, cutting balloon catheters, or kissing-balloon inflation, resulting in the need to upscale for larger guiding catheters in approximately 7% of procedures. Use of 5 Fr guiding catheters for routine transradial angioplasty should probably be reserved for particular cases, such as patients with small radial arteries, for comfort issues, or when deep intubation is intended.
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