Direct stent implantation using the EXPRESS Coronary Stent System: results of a multi-center feasibility study.
The aim of this prospective, multicenter, single arm study was to assess the safety and feasibility of EXPRESS Coronary Stent implantation in native coronary arteries without balloon predilatation. Forty-two patients with de novo or restenotic lesions were enrolled, of which 38 were eligible for analysis. The coronary lesions were predominantly complex, occurring in arteries with a mean reference diameter of 2.80 +/- 0.49 mm. Technical and procedural success were achieved in 89.5% and 84% of the cases respectively. The mean minimal lumen diameter increased from 1.08 +/- 0.26 mm to 2.55 +/- 0.44 mm and diameter stenosis decreased from 61 +/- 7% to 13 +/- 8%. The primary endpoint of major adverse cardiac events at 30 days was 2.6% and was limited to only one event (target vessel revascularization, nontarget lesion). No other MACE were observed during the three-month follow-up period. Based on the findings of this study, direct stenting with the EXPRESS Stent appears feasible and is well tolerated.
Silber
Sigmund
S
Internistische Klinik Dr. Müller, Herzkatheterlabor Cardiology Associates, Munich, Germany. silber@med.de
Grube
Eberhard
E
Marco
Jean
J
Grollier
Gilles
G
Morice
Marie-Claude
MC
Serruys
Patrick
P
Cobaugh
Michael
M
Wijns
William
W
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D009204:Myocardial Revascularization; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome