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Published on: May 14, 2013
Sirolimus-eluting versus uncoated stents in acute myocardial infarction
Christian Spaulding1, Patrick Henry, Emmanuel Teiger
1Assistance Publique-Hôpitaux de Paris (AP-HP) Cochin Hospital, Paris 5 Medical School Rene Descartes University and INSERM U780, Paris, France. christian.spaulding@cch.ap-hop-paris.fr
Insights
Sirolimus-eluting stents significantly reduced target-vessel revascularization in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction. This study found no significant difference in death, reinfarction, or stent thrombosis rates.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- Sirolimus-eluting stents (SES) are known to reduce restenosis and reintervention compared to uncoated stents.
- Limited data exist on SES use in primary percutaneous coronary intervention (PCI) for ST-elevation acute myocardial infarction (STEMI).
Purpose of the Study:
- To compare the safety and efficacy of SES versus uncoated stents in primary PCI for STEMI.
- To evaluate target-vessel failure rates at one year post-procedure.
Main Methods:
- A single-blind, multicenter, prospectively randomized trial involving 712 patients across 48 centers.
- Primary endpoint: target-vessel failure at 1 year (death, MI, or revascularization).
- Angiographic substudy at 8 months in 174 patients.
Main Results:
- Significantly lower primary endpoint rate in the SES group (7.3% vs. 14.3%, P=0.004).
- Reduction driven by decreased target-vessel revascularization (5.6% vs. 13.4%, P<0.001).
- No significant differences in death, reinfarction, or stent thrombosis.
Conclusions:
- Sirolimus-eluting stents significantly reduce target-vessel revascularization in selected STEMI patients at one year.
- SES demonstrate a favorable safety profile in this high-risk population.
Background:
Sirolimus-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of such stents in primary percutaneous coronary intervention (PCI) for acute myocardial infarction with ST-segment elevation.
Methods:
We performed a single-blind, multicenter, prospectively randomized trial to compare sirolimus-eluting stents with uncoated stents in primary PCI for acute myocardial infarction with ST-segment elevation. The trial included 712 patients at 48 medical centers. The primary end point was target-vessel failure at 1 year after the procedure, defined as target-vessel-related death, recurrent myocardial infarction, or target-vessel revascularization. A follow-up angiographic substudy was performed at 8 months among 174 patients from selected centers.
Results:
The rate of the primary end point was significantly lower in the sirolimus-stent group than in the uncoated-stent group (7.3% vs. 14.3%, P=0.004). This reduction was driven by a decrease in the rate of target-vessel revascularization (5.6% and 13.4%, respectively; P<0.001). There was no significant difference between the two groups in the rate of death (2.3% and 2.2%, respectively; P=1.00), reinfarction (1.1% and 1.4%, respectively; P=1.00), or stent thrombosis (3.4% and 3.6%, respectively; P=1.00). The degree of neointimal proliferation, as assessed by the mean (+/-SD) in-stent late luminal loss, was significantly lower in the sirolimus-stent group (0.14+/-0.49 mm, vs. 0.83+/-0.52 mm in the uncoated stent group; P<0.001).
Conclusions:
Among selected patients with acute myocardial infarction, the use of sirolimus-eluting stents significantly reduced the rate of target-vessel revascularization at 1 year. (ClinicalTrials.gov number, NCT00232830 [ClinicalTrials.gov].).
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