TY - JOUR
T1 - Heparin-coated Wiktor stents in human coronary arteries (MENTOR Trial)
AU - Vrolix, Matty C M
AU - Legrand, Victor M.
AU - Reiber, Johan H C
AU - Grollier, Gille
AU - Schalij, Martin J.
AU - Brunel, Philippe
AU - Martinez-Elbal, Louis
AU - Gomez-Recio, Manuel
AU - Bär, Frits W H M
AU - Bertrand, Michel E.
AU - Colombo, Antonio
AU - Brachman, Johannes
PY - 2000/8/15
Y1 - 2000/8/15
N2 - The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on the well-known Wiktor stent device. Heparin-coated Wiktor stent implantation was performed in 132 consecutive patients (132 lesions) in a multicenter international trial from September 1996 to February 1997. Forty-three percent of patients had unstable angina, 33% had previous myocardial infarction, and 10% had diabetes mellitus. Patients were followed for 12 months for occurrence of major adverse cardiovascular events, and 96% of the eligible patients underwent quantitative angiographic control at 6 months. Stent deployment was successful in 95.5% of lesions. Minimal lumen diameter increased by 1.67 ± 0.48 mm (from 1.02 ± 0.38 mm before to 2.69 ± 0.37 mm after the stent implantation). Mean percent diameter stenosis decreased from 67.4 ± 11.3% before to 18.9 ± 7.7% after the intervention. A successful intervention (<50% diameter stenosis and no major adverse cardiac events within 30 days) occurred in 97% of the patients. The subacute thrombosis rate was 0.8%, which compares favorably with historical controls of this stent, and a low incidence of postprocedural increase in creatine kinase-MB was noted. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 ± 0.69 mm and a loss index of 0.48 ± 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent. (C) 2000 by Excerpta Medica, Inc.
AB - The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on the well-known Wiktor stent device. Heparin-coated Wiktor stent implantation was performed in 132 consecutive patients (132 lesions) in a multicenter international trial from September 1996 to February 1997. Forty-three percent of patients had unstable angina, 33% had previous myocardial infarction, and 10% had diabetes mellitus. Patients were followed for 12 months for occurrence of major adverse cardiovascular events, and 96% of the eligible patients underwent quantitative angiographic control at 6 months. Stent deployment was successful in 95.5% of lesions. Minimal lumen diameter increased by 1.67 ± 0.48 mm (from 1.02 ± 0.38 mm before to 2.69 ± 0.37 mm after the stent implantation). Mean percent diameter stenosis decreased from 67.4 ± 11.3% before to 18.9 ± 7.7% after the intervention. A successful intervention (<50% diameter stenosis and no major adverse cardiac events within 30 days) occurred in 97% of the patients. The subacute thrombosis rate was 0.8%, which compares favorably with historical controls of this stent, and a low incidence of postprocedural increase in creatine kinase-MB was noted. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 ± 0.69 mm and a loss index of 0.48 ± 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent. (C) 2000 by Excerpta Medica, Inc.
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U2 - 10.1016/S0002-9149(00)00951-6
DO - 10.1016/S0002-9149(00)00951-6
M3 - Article
C2 - 10946029
AN - SCOPUS:0034663643
VL - 86
SP - 385
EP - 389
JO - American Journal of Cardiology
JF - American Journal of Cardiology
SN - 0002-9149
IS - 4
ER -