The ESSEX (European Scimed Stent Experience) study

The aim of the study was to assess the safety and feasibility of implantati on of the Scimed Radius stent. Secondary objectives were to assess the resu lt of stent placement by quantitative coronary angiography (QCA) and intrav ascular ultrasound (IVUS). The ESSEX study was a prospective, multicenter, observational study in which candidates for a single elective stent implant ation, in a de novo or restenotic lesion, reference diameter 2.75-4.00 mm a nd target lesion < 14 mm in length, were enrolled. QCA at baseline, postpro cedure, and 6-month follow-up was performed. IVUS was used to assess optima l stent implantation. One hundred and three patients were enrolled. Forty-f our percent of the patients had unstable angina, Stent implantation was tec hnically successful in all patients. Additional stents were implanted in 17 patients for procedural dissection (16) and spasm (1). Ninety-seven percen t of patients were event-free at 1 month and 76% at 6-month follow-up. Angi ographic restenosis rates for de novo lesions and for all patients were 19% and 21%, respectively. Clinical events occurred at 1- and 6-month follow-u p in 2.9% and 24.3% of patients, respectively. No patients suffered subacut e thrombosis. Retrospective analysis of peak balloon inflation pressure (le ss than or equal to 12 and > 12 atm) as a determinant of clinical, QCA, and IVUS outcomes suggested no benefit or detrimental effect from optimization with high-pressure balloon inflation. Implantation of the self-expanding R adius stent is safe and efficacious. Based on registry data, clinical, angi ographic, and IVUS, data comparable with modern balloon-expandable stents w ere obtained. Cathet Cardiovasc. Intervent 50:419-425, 2000. (C) 2000 Wiley -Liss, Inc.