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ȣ - 480238 17 |
Clinical Outcomes of the First 1252 Patients Treated with Sirolimus-eluting Stent: A Single Center Post Marketing Surveillance Study |
Cardiovascular Center, Korea University Guro Hospital¹ , Washington Hospital Center, Washington DC² |
Seung-Woon Rha¹, Soon Yong Suh¹ , Hyun Hee Kim¹ , Soon Jun Hong¹ , Jin Won Kim¹ , Chang Gyu Park¹ , Hong Seog Seo¹ , Dong Joo Oh¹ , Young Moo Ro¹ , Ron Waksman² |
Background: The Sirolimus-eluting Stent (SES) is currently being used in patients (pts) undergoing percutaneous coronary intervention (PCI). We report our initial results from a post marketing surveillance with the use of SES in everyday ‘real world’ clinical practice.
Methods: Data of the first 1252 consecutive pts (1405 lesions) treated with the SES since its approval was collected and analyzed. All pts were discharged with antiplatelet therapy for 3 to 12 months. Pts were followed at 30 days and 6 months from the date of SES implantation by telephone contact or office visit.
Results: Baseline characteristics included mean age 64±11 years, males 64.2%, and diabetics 34.4%. The SES was implanted in complex lesions (type B/C lesion) 92.1%, in-stent restenosis (ISR) 8.1%, total occlusion 3.5 %, acute myocardial infarction (MI) 9.1%, left main 1.5%, ostial lesion 5.1% and saphenous vein grafts 3.8%. The overall number of SES utilized per procedure was 1.28±0.6. The mean SES length was 21.96±6.5 mm and 438 lesions (31.2 %) were implanted with long SES (>25 mm). The mean SES diameter was 3.17±1.2 mm and 306 lesions (21.8 %) received a small SES (2.5 mm). IVUS guided PCI was performed in 80.3% of cases. The procedural success rate was 97.3% and the clinical success was 98.6%. In-hospital, 30-day and 180-day clinical outcomes are shown in the table.
Conclusion: The initial experience with the routine use of SES for PCI showed high feasibility and safety with low overall clinical event rates up to 6 months. Efforts should be directed to minimize the thrombosis rate and to ensure the durability of these results.
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% |
In-hospital (n=1252) |
30-day (n=863) |
6-month (n=690) |
Death |
0.0 |
0.9 |
3.0 |
Q-wave
MI |
0.2 |
0.6 |
1.8 |
TLR |
1.0 |
0.1 |
2.0 |
TVR |
1.0 |
0.2 |
3.8 |
TVR
MACE |
1.4 |
1.4 |
7.5 |
Thrombosis |
0.2 |
0.4 |
1.1 |
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