Objective: To evaluate the safety and feasibility of a new 0.010-inch guidewire and a specialized balloon catheter for the 0.010-inch guidewire in routine percutaneous coronary intervention (PCI).
Background: Several reports have shown that a new 0.010-inch system is effective for specific situations where reduction of catheter size may be necessary. However, the safety of this system in routine PCI is unknown.
Methods: The IKATEN registry is a prospective, multicenter, nonrandomized registry study. Patients who underwent elective PCI with a 0.010-inch guidewire and its associated balloon catheter as primary devices were enrolled. The coprimary endpoints were clinical success and device success rates. The secondary endpoints were major adverse cardiac events (MACE) and bleeding complications.
Results: A total of 133 patients with 148 lesions were enrolled. The majority were male (75.3%), and mean age was 68 +/- 10 years. Type B2/C lesions comprised 60% of the lesions, prevalence of chronic total occlusion (CTO) was 16.9%, and bifurcation lesions were found in 22.3% of patients. A transradial approach was used in 79.7% of patients, and the average guiding catheter size was 5.1 +/- 0.4 Fr. Clinical success rate was 99.2%, and device success rate was 99.3%. Device failure occurred only in one case of chronic total occlusion because of unsuccessful guidewire passage. No MACE or bleeding complications were reported except for a small hematoma at the puncture site in one patient. Stent delivery success rate on 0.010-inch guidewire was 93.9% because of failure of stent balloon to pass eight lesions.
Conclusion: The IKATEN registry data suggest that the 0.010-inch system is safe and its use is feasible in routine PCI including bifurcation and CTO lesions.
Copyright 2009 Wiley-Liss, Inc.