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Sponsored by: |
University of Zagreb |
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Information provided by: | University of Zagreb |
ClinicalTrials.gov Identifier: | NCT00452517 |
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 were analysed.
Condition | Intervention | Phase |
---|---|---|
Acute Coronary Syndrome |
Procedure: Percutaneous Coronary Intervention |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome: Clinical and Angiographic Follow-up |
Estimated Enrollment: | 100 |
Study Start Date: | March 2004 |
Study Completion Date: | November 2004 |
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SG-SIR-BM-07 |
Study First Received: | March 26, 2007 |
Last Updated: | March 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00452517 History of Changes |
Health Authority: | Croatia: University hospital Zagreb Ethical Committee |
bare metal stents sirolimus-eluting stents coronary polytetrafluoroethylene stent graft acute coronary syndrome |
quantitative coronary angiography analysis major adverse cardiac events in-stent restenosis target lesion revascularisation |
Sirolimus Anti-Infective Agents Anti-Bacterial Agents Heart Diseases Immunologic Factors Antifungal Agents |
Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases Ischemia Immunosuppressive Agents |
Sirolimus Anti-Infective Agents Disease Heart Diseases Immunologic Factors Antineoplastic Agents Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Antifungal Agents Syndrome Therapeutic Uses Acute Coronary Syndrome Cardiovascular Diseases |