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J Interv Cardiol, 16: 491-497
Direct stent implantation using the Express Coronary Stent System: results of a multi-center feasibility study.
Silber S, Grube E, Marco J, Grollier G, Morice MC, Serruys P,
Cobaugh M, Wijns W.
Internistische Klinik Dr. Muller, Herzkatheterlabor Cardiology
Associates, Munich, Germany. silber@med.de
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.
Publication Types:
· Clinical Trial
· Multicenter Study
PMID: 14632946 [PubMed]