Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
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|ClinicalTrials.gov Identifier: NCT00452517|
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : March 27, 2007
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Procedure: Percutaneous Coronary Intervention||Phase 4|
Background: Percutaneous coronary intervention with stent implantation is a standard therapy for patients with acute coronary syndrome. The in-stent restenosis is still a problem. Recently, drug eluting stents reduce the incidence of this unfavorable event. The primary role of the polytetrafluoroethylene stent graft (PTFE) is management of coronary perforations, closure of coronary aneurysms, and in degenerated saphenous vein grafts. We compared these stents in native coronary vessels in patients with acute coronary syndrome with sirolimus and bare metal stents, for possible reduction of in-stent restenosis.
Methods and results: During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). Demographic, angiographic and procedural characteristics were similar for all three groups. The incidence of 6-month major adverse coronary events was similar in all three groups. The target lesion revascularisation was higher in the bare metal stent group (P=0.044). The primary end-point, restenosis rate at six-month follow-up was higher in the bare metal stent group, compared with the stent graft and sirolimus eluting stent groups. The percent diameter stenosis in follow-up was significantly higher in bare metal stent group (P=0.005). The late loss was significantly lower in the sirolimus eluting stent group (0.23 mm), compared with the bare metal stent group (P= 0.034). There was a trend of lower late loss in the stent graft group, compared with bare metal stent group.
Conclusion: Three groups of stents implanted in patients with acute coronary syndrome (stent-graft, sirolimus and bare metal), did not differ regarding the incidence of major adverse cardiac events. Sirolimus-eluting stents had a lower incidence of in-stent restenosis in comparison with bare metal stent group. Stent graft implanted in native coronary arteries appears to be safe and efficient in patients with acute coronary syndrome, but a significant reduction of in-stent restenosis was not achieved.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome: Clinical and Angiographic Follow-up|
|Study Start Date :||March 2004|
|Study Completion Date :||November 2004|
- Three groups of stents implanted in patients with acute coronary syndrome (stent-graft, sirolimus and bare metal), did not differ regarding the incidence of major adverse cardiac events.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452517
|University hospital Zagreb|
|Zagreb, Croatia, 10000|
|Principal Investigator:||Maja Strozzi, MD||University hospital Zagreb|