Acute and six-month clinical outcome after Helistent stent implantation in coronary arteries: results of the French Helistent multicenter registry.

Abstract

The purpose of our study was to determine the feasibility, safety, and efficacy of the new tubular (Helistent) stent (Hexacath, France) in patients with coronary artery disease. Patients were prospectively included in a multicenter French registry: acute results and 6-month target lesion revascularization rate were assessed. A total of 628 stents were implanted in 527 patients (616 lesions). Mean age was 64 +/- 11 years. Predilatation was performed in 77% of cases. The stent was successfully deployed in 99.4% of attempted lesions. Three patients died during the hospital stay and 10 patients developed myocardial infarction. Angiographic stent thrombosis rate was 1.1%. There was no need for urgent cardiac surgery during hospital stay. Six-month clinical follow-up was obtained in 95% of patients; target lesion revascularization rate was 8.3%. Eight patients (1.6%) (extracardiac death in three patients) died and three patients (0.6%) developed myocardial infarction. In conclusion, the Helistent stent appears safe and effective in minimizing acute complications of elective coronary interventions. Six-month major cardiac events were rare and clinical restenosis was low (< 10%).