Immediate results and late clinical outcomes after new CrossFlex coronary stent implantation

This study evaluates the safety and efficacy of the new CrossFlex stent in the treatment of native coronary artery disease. The CrossFlex stent is a flexible, balloon-expandable new device with an excellent flexibility, radial strength, conformability, and radio-opacity. Little data are available concerning the clinical and angiographic outcomes of this device. The CrossFlex stent was implanted in 209 consecutive patients with 226 lesions. Follow-up angiography was performed at 6 months, and clinical evaluation was undertaken at regular intervals after stent implantation. Procedural success was achieved in all lesions without in-hospital complications. Angiographic follow-up data were available in 153 of the 187 eligible lesions (follow-up rate, 82%), and the overall angiographic restenosis rate was 16.3%. Minimal lumen diameter immediately after stent placement was the only predictor of angiographic restenosis. Clinical follow-up was obtained in all patients at 10.5 +/- 5.2 months. There were 4 deaths (1 cardiac in origin, the others noncardiac in origin), and 1 nonfatal myocardial infarction (nonstented artery) during follow-up. Target lesion revascularization was required in 15 patients (7%), and the overall event-free survival rate (death, myocardial infarction, and repeat revascularization) was 87% at the end of the follow-up period. The CrossFlex stent is a safe and effective device with a high procedural success rate, and a favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials are needed to compare the CrossFlex stent with standard slotted-tube stents.