TY - JOUR
T1 - Long-Term Follow-Up of Drug-Eluting Stents When Inserted for On- and Off-Label Indications
AU - Qasim, Asif
AU - Cosgrave, John
AU - Latib, Azeem
AU - Colombo, Antonio
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2007/12/1
Y1 - 2007/12/1
N2 - This study reports long-term follow-up of the on- and off-label implantation of drug-eluting stents (DESs) in a retrospective study of 1,044 patients. Off-label implantation of DESs was performed for left main coronary artery lesions, bifurcation lesions, bare metal stent restenosis, ostial disease, chronic total occlusions, saphenous vein graft lesions, internal mammary artery graft lesions, left ventricular ejection fraction <30%, and acute myocardial infarction. End points examined were procedural complications, in-hospital myocardial infarction, and acute stent thrombosis; end points examined at follow-up were subacute stent thrombosis, late stent thrombosis, target vessel revascularization, myocardial infarction, death, and major adverse clinical events (MACEs; a composite of death, myocardial infarction, and target vessel revascularization). The study included 364 patients who received a DES on an on-label basis and 680 patients who received a DES on an off-label basis. Patient characteristics were not significantly different between the 2 groups, and there was no difference in procedural complications or acute stent thrombosis (on-label, 0%; off-label, 0.3%; p = 0.55). There were no significant differences in subacute stent thrombosis (0% vs 0.6%, p = 0.3), late stent thrombosis (1.4% vs 1.2%, p = 0.78), death at follow-up (4.9% vs 4.1%, p = 0.53), or myocardial infarction (1.9% vs 2.4%, p = 0.83). Off-label DES implantation was associated with higher rates of target vessel revascularization (13.2% vs 24.1%, p = 0.0001) and MACEs (17.6% vs 28.2%, p = 0.0001). Multivariate analysis showed associations between target vessel revascularization and MACEs (respective p values) with bare metal stent restenosis (p = 0.001 and p = 0.001), diabetes mellitus (p = 0.002 and p = 0.001), and previous coronary artery bypass grafting (p = 0.04 and p = 0.01), but not off-label DES implantation (p = 1.36 and p = 1.16). In conclusion, DES use in the off-label situations studied was safe and was not associated with increased stent thrombosis, myocardial infarction, or death. Multivariate analysis showed that off-label DES implantation was not a risk factor for target vessel revascularization or MACEs.
AB - This study reports long-term follow-up of the on- and off-label implantation of drug-eluting stents (DESs) in a retrospective study of 1,044 patients. Off-label implantation of DESs was performed for left main coronary artery lesions, bifurcation lesions, bare metal stent restenosis, ostial disease, chronic total occlusions, saphenous vein graft lesions, internal mammary artery graft lesions, left ventricular ejection fraction <30%, and acute myocardial infarction. End points examined were procedural complications, in-hospital myocardial infarction, and acute stent thrombosis; end points examined at follow-up were subacute stent thrombosis, late stent thrombosis, target vessel revascularization, myocardial infarction, death, and major adverse clinical events (MACEs; a composite of death, myocardial infarction, and target vessel revascularization). The study included 364 patients who received a DES on an on-label basis and 680 patients who received a DES on an off-label basis. Patient characteristics were not significantly different between the 2 groups, and there was no difference in procedural complications or acute stent thrombosis (on-label, 0%; off-label, 0.3%; p = 0.55). There were no significant differences in subacute stent thrombosis (0% vs 0.6%, p = 0.3), late stent thrombosis (1.4% vs 1.2%, p = 0.78), death at follow-up (4.9% vs 4.1%, p = 0.53), or myocardial infarction (1.9% vs 2.4%, p = 0.83). Off-label DES implantation was associated with higher rates of target vessel revascularization (13.2% vs 24.1%, p = 0.0001) and MACEs (17.6% vs 28.2%, p = 0.0001). Multivariate analysis showed associations between target vessel revascularization and MACEs (respective p values) with bare metal stent restenosis (p = 0.001 and p = 0.001), diabetes mellitus (p = 0.002 and p = 0.001), and previous coronary artery bypass grafting (p = 0.04 and p = 0.01), but not off-label DES implantation (p = 1.36 and p = 1.16). In conclusion, DES use in the off-label situations studied was safe and was not associated with increased stent thrombosis, myocardial infarction, or death. Multivariate analysis showed that off-label DES implantation was not a risk factor for target vessel revascularization or MACEs.
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U2 - 10.1016/j.amjcard.2007.07.013
DO - 10.1016/j.amjcard.2007.07.013
M3 - Article
C2 - 18036358
AN - SCOPUS:36248965268
SN - 0002-9149
VL - 100
SP - 1619
EP - 1624
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 11
ER -