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ȣ - 510790 117 |
Clinical Outcomes associated with On versus Off-Label Use of Drug-Eluting Stents |
영남대학병원 순환기 내과 |
김웅, 박종선, 이원재, 이상희, 홍그루, 신동구, 김영조, 심봉섭 |
Background and Objectives : The aim of study is to determine clinical outcomes of DES usuage in on or off-label conditions at routine clinical practice Materials and Methods : From April 2005 to August 2006, consecutive patients who were implanted with DES were enrolled in this study. The patients were divided into 2 groups based on the presence of at least one off-label characteristics which were not indicated on the package descriptions of sirolimus- and paclitaxel-eluting stents. The major adverse cardiac events (MACE) were analyzed during the index admission, at one month and one year Results : Of the 517 patients, 262 patients (50.7%) had at least one off-label indications During the hospitalization, no MACE occurred in on-label patient and death due to cardiogenic shock occurred in one patient of off-label patient (0.4%, p=1.0). At one month, MACE occurred only in 3 off-label patients (1.1%, p=0.087). At one year, MACE occurred more high in off-label than on-label patients (1.2% vs 6.2%, p=0.003). Stent thrombosis (ST) occurred only in 4 off-label patients (1.6%); 1 subacute ST, 3 late ST. Conclusion : Although off-label use of DES shows comparable outcomes in short term, long-term clinical outcomes may be more worse than on-label usuage.
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Plus Web Editor Control By Ensys co., Ltd
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On-label(n=255) |
Off-label(n=262) |
P |
In-hospital
MACE |
|
|
1.0 |
Death |
0 |
1(0.4%) |
1.0 |
One Month
MACE |
0 |
3(1.1%) |
0.087 |
Death |
0 |
2(0.8%) |
0.162 |
TVR |
0 |
1(0.4%) |
0.323 |
One Year
MACE |
3(1.2%) |
16(6.2%) |
0.003 |
Death |
1(0.4%) |
5(1.9%) |
0.106 |
TLR |
2(0.8%) |
7(2.7%) |
0.099 |
TVR |
2(0.8%) |
11(4.3%) |
0.013 |
MI |
1(0.4%) |
0 |
0.312 |
Total
MACE |
3(1.2%) |
20(7.6%) |
0.001 |
** MACE : major adverse
cardiac events, TLR : target lesion revascularization, TVR : target vessel
revascularization, MI : myocardial
infarction
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