Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome: Clinical and Angiographic Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452517
• Other study ID #: SG-SIR-BM-07
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2007
• Last updated: March 26, 2007
• Start date: March 2004
• Est. completion date: November 2004

Study information

• Verified date: March 2007
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: University hospital Zagreb Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• stent implantation in acute coronary syndrome

Exclusion Criteria:

• previous percutaneous coronary intervention or coronary artery bypass graft surgery

• multivessel, diffuse disease, tortuous vessel

• arteries less than 3 mm in diameter

• distal stenosis location

• left main and bifurcation lesions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Procedure:
• Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Croatia	University hospital Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (2)

Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials. Lancet. 2006 Feb 18;367(9510):579-88. Review. Erratum in: Lancet. 2006 May 20;367(9523):1656. — View Citation

Saia F, Lemos PA, Lee CH, Arampatzis CA, Hoye A, Degertekin M, Tanabe K, Sianos G, Smits PC, McFadden E, Hofma SH, van der Giessen WJ, de Feyter PJ, van Domburg RT, Serruys PW. Sirolimus-eluting stent implantation in ST-elevation acute myocardial infarction: a clinical and angiographic study. Circulation. 2003 Oct 21;108(16):1927-9. Epub 2003 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.