Comparison of 6 and 7 French guiding catheters for percutaneous coronary intervention: results of a randomised trial with a vascular ultrasound endpoint.
OBJECTIVE: To perform a randomized, ultrasound controlled trial to define the procedural and clinical advantages and limitations of 6 French (Fr) compared with 7 Fr transfemoral coronary intervention in the stenting era. BACKGROUND: The use of 7 Fr guiding catheters may facilitate Percutaneous Coronary Intervention (PCI), but may be associated with increased vascular complications when compared with 6 Fr catheters. METHODS: Patients undergoing PCI considered suitable for either a 6 or 7 Fr sheath and guiding catheter system were included. All vascular sheaths were removed with assisted manual compression. Femoral vascular ultrasounds were performed prior to hospital discharge and interpreted by a vascular surgeon blinded to treatment assignment. The primary endpoint was a composite of significant vascular complications including major haematoma, retroperitoneal haematoma, pseudoaneurysm, arterio-venous fistula, or femoral venous or arterial thrombosis. RESULTS: During the study, 414 patients (mean age 61+/-11 years, 27% females) were randomly assigned to 6 Fr or 7 Fr sheath groups. The incidence of major vascular complications was 5.7% in the 6 Fr group and 3.9% in the 7 Fr group (P=0.383). There was no significant difference in procedural or angiographic success between the groups. The use of contrast volume was higher in the 7 Fr group (157+/-58 ml vs. 144+/-58 ml; P=0.029). There was a trend toward better operator satisfaction with the 7 Fr guide (P=0.08). CONCLUSIONS: This prospective, randomized trial indicates no reduction in major peripheral vascular complications with the use of smaller guiding catheters in PCI. There was less contrast used in the 6 Fr group, which may benefit some patient subsets, however operators tended to prefer the larger 7 Fr system. The target coronary anatomy and need for complex device intervention should mandate the choice of guiding catheter size, not a perceived impact on vascular complications.