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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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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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