Immediate Results After CrossFlex Stent Implantation

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Abstract

BACKGROUND
The CrossFlex TM stent is a flexible, balloon-expandable new device with an excellent flexibility, radial strength, and conformability. The aim of this study was to evaluate the safety and efficacy of the new CrossFlex stent in the treatment of native coronary artery diseases.
METHODS
The CrossFlex TM stent was implan-ted in 328 consecutive patients (mean age 60+/-10, M/F=2.6:1) with the 345 lesions. Stent deployment was accomplished with a single inflation to 14 - 16 atmospheres without adjunct high-pressure balloon dilatation (single high pressure technique). Intravascular ultrasound (IVUS) imaging was performed to evaluate the results of stent deployment in selected patients.
RESULTS
The indications for stent implantation were elective in 304 lesions (88.1%), suboptimal angioplasty results in 15 lesions (4.4%), and threatened or acute vessel closure in 26 lesions (7.5%). Procedural success rate was 99.1%, and nonfatal myocardial infarction occurred in 3 patients (0.9%) after stent deployment. The minimal lumen diameter increased from 0.8+/-0.4 to 3.2+/-0.5 mm, and the diameter stenosis decreased from 74+/-13 to 0.5+/-9%. IVUS was performed in 40 lesions at the time of stent implantation. The IVUS images after stenting seemed to be more like slotted-tube stents than coil stents. Mild plaque prolapse within the stent occurred in 3 lesions. There were no lesions of incomplete stent apposition using single high-pressure technique.
CONCLUSIONS
The CrossFlex TM stent is a safe and effective device with a high procedural success rate for treatment of native coronary artery disease. Further studies may be needed to assess late clinical outcomes of this stent.