Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): Percutaneous Coronary Intervention
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 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