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Drug-Eluting Stent Late Thrombosis Meta-Analysis - Drug-Eluting Stent Late Thrombosis Meta-Analysis - Presented at TCT 2006
Description:
The goal of the study was to evaluate treatment with drug-eluting stents compared with bare-metal stents (BMS) on death or Q-wave myocardial infarction (MI) among randomized trials of drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo coronary lesions.
Study Design
Study Design:
Patients Enrolled: 5,108
Mean Follow Up: 3 years
Primary Endpoints:
Death or Q-wave MI
Drug/Procedures Used:
Data were drawn from randomized trials of first-generation DES compared with BMS. Endpoints evaluated were death, Q-wave MI, and the composite of death or Q-wave MI. Trials included in the meta-analysis were RAVEL, SIRIUS, ESIRIUS, and C-SIRIUS (sirolimus-eluting stents [SES]; n = 878 for SES and n = 870 for BMS) and TAXUS I, II, IV, V, and VI (paclitaxel-eluting stents [PES]; n = 1,685 for PES and n = 1,675 for BMS).
Principal Findings:
For the comparison of BMS (n = 870) with SES (n = 878), the rate of death or Q-wave MI was 0.9% for BMS versus 1.7% for SES at 6-9 months (p = 0.21), 1.4% for BMS versus 2.3% for SES at 1 year (p = 0.30), 2.0% for BMS versus 3.7% for SES at 2 years (p = 0.09), and 4.0% for BMS versus 6.0% for SES at 3 years (p = 0.06).
For the comparison of BMS (n = 1,675) with PES (n = 1,685), the rate of death or Q-wave MI was 1.5% for BMS versus 1.6% for PES at 6-9 months (p = 0.88), 1.6% for BMS versus 1.7% for PES at 1 year (p = 0.80), 2.8% for BMS versus 2.6% for PES at 2 years (p = 0.78), and 3.1% for BMS versus 3.5% for PES at 3 years (p = 0.60).
At last available follow-up, death or Q-wave MI was significantly higher in the SES group compared with the BMS group (6.3% vs. 3.9%, relative risk [RR] 1.38, p = 0.03). The rate of death or Q-wave MI at last follow-up did not differ significantly for PES compared with BMS (2.6% vs. 2.3%, RR 1.16, p=0.68).
Interpretation:
In a meta-analysis of randomized trials of patients undergoing PCI for de novo coronary lesions, treatment with SES was associated with a significant increase in death or Q-wave MI at late follow-up compared with BMS. Death or Q-wave MI at 3 years did not differ between PES and BMS.
Late stent thrombosis has been a concern regarding DES use due to a reduction in endothelialization. Randomized trials of DES compared with BMS in de novo coronary lesions have consistently shown reductions in the need for repeat revascularization due to restenosis. However, none has been adequately powered to evaluate harder endpoints of death or MI, and follow-up is only now beginning to be long enough to more fully assess late thrombosis. Restenosis, while a negative consequence of PCI, is a nonfatal event and has not been linked to increased mortality.
The present meta-analysis demonstrates a significant increase in late death and Q-wave MI with SES. Another recent meta-analysis demonstrated higher rates of noncardiac death by 2 years with SES compared with BMS. However, a meta-analysis presented at TCT showed higher late stent thrombosis but no difference in death or MI. The reason for the difference in those results using patient level data compared with the present meta-analysis using published data are not known. Continued longer-term follow-up of late stent thrombosis should be closely monitored.
References:
Presented by Dr. E. Camenzind at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
Presented by Dr. E. Camenzind, European Society of Cardiology Scientific Congress, September 2006.
Keywords: Paclitaxel, Myocardial Infarction, Coronary Restenosis, Metals, Thrombosis, Drug-Eluting Stents, Sirolimus, Angioplasty, Balloon, Coronary
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