The ESSEX (European Scimed Stent Experience) study.
The aim of the study was to assess the safety and feasibility of implantation of the Scimed Radius stent. Secondary objectives were to assess the result of stent placement by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). The ESSEX study was a prospective, multicenter, observational study in which candidates for a single elective stent implantation, in a de novo or restenotic lesion, reference diameter 2.75-4.00 mm and target lesion < 14 mm in length, were enrolled. QCA at baseline, postprocedure, and 6-month follow-up was performed. IVUS was used to assess optimal stent implantation. One hundred and three patients were enrolled. Forty-four percent of the patients had unstable angina. Stent implantation was technically successful in all patients. Additional stents were implanted in 17 patients for procedural dissection (16) and spasm (1). Ninety-seven percent of patients were event-free at 1 month and 76% at 6-month follow-up. Angiographic restenosis rates for de novo lesions and for all patients were 19% and 21%, respectively. Clinical events occurred at 1- and 6-month follow-up in 2.9% and 24.3% of patients, respectively. No patients suffered subacute thrombosis. Retrospective analysis of peak balloon inflation pressure (< or = 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 Radius stent is safe and efficacious. Based on registry data, clinical, angiographic, and IVUS, data comparable with modern balloon-expandable stents were obtained.
Thoraxcenter, Rotterdam, The Netherlands.
I P
IP
Kay
M
M
Sabate
G
G
Van Langenhove
G R
GR
Heyndrickx
G
G
Grollier
H
H
Suyrapranata
J C
JC
Hoorntje
W J
WJ
van der Giessen
M A
MA
Morel
C
C
Disco
P W
PW
Serruys
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019370:Observation; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012449:Safety; D015607:Stents; D018084:Ultrasonography, Interventional