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Randomized comparison of carbon ion-implanted stent versus bare metal stent in coronary artery disease: the Asian Pacific Multicenter Arthos Stent Study (PASS) trial.

Authors
Kim, YH; Lee, CW; Hong, MK; Park, SW; Tahk, SJ; Yang, JY; Saito, S; Santoso, T; Quan, L; Ge, J; Weissman, NJ; Lansky, AJ; Mintz, GS; Park, SJ
Citation
American heart journal, 149(2):336-341, 2005
Journal Title
American heart journal
ISSN
0002-87031097-6744
Abstract
BACKGROUND: Heavy metal ions can cause allergic and inflammatory reactions that might be associated with in-stent restenosis. This randomized multicenter clinical study was designed to determine if carbon ion-implanted stents reduce luminal late loss by blocking heavy metal ion diffusion into the surrounding tissue.



METHODS: A total of 225 patients with 230 native coronary lesions were randomly assigned to receive either a carbon ion-implanted Arthos Inert stent (group 1, n = 113) or a bare metal Arthos stent (group 2, n = 117). The primary endpoint was in-stent luminal late loss at 6-month angiographic follow-up, and the secondary endpoints were the 6-month angiographic restenosis rate and the occurrence of the major adverse cardiac events (MACE) including death, nonfatal myocardial infarction, and target lesion revascularization at 12 months.



RESULTS: The baseline characteristics were similar in the 2 groups. In-hospital events did not occur in any patients. Angiographic follow-up at 6 months was obtained in 184 lesions (80%). At follow-up, the luminal late loss was similar in the 2 groups (0.91 +/- 0.77 mm in group 1 vs 0.88 +/- 0.80 mm in group 2, P = .79), and the angiographic restenosis rates were 11.0% in group 1 and 16.1% in group 2 (P = .31). The occurrence rates of MACE at 12 months were 9.1% in group 1 and 10.4% in group 2 (P = .73).



CONCLUSIONS: The initial and long-term outcomes of the carbon ion-implanted stent were excellent. However, it did not improve long-term outcomes vs the bare metal stent.
MeSH terms
Angioplasty, Balloon, CoronaryCarbonCoated Materials, BiocompatibleCoronary AngiographyCoronary Restenosis/prevention & controlCoronary Stenosis/therapy*FemaleHumansMaleMiddle AgedProsthesis DesignStents*/adverse effects
DOI
10.1016/j.ahj.2004.02.018
PMID
15846274
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
AJOU Authors
탁, 승제
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