Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis - Drug-eluting stents vs thin-strut bare stents
The goal of the trial was to evaluate the efficacy of a thin, bare metal strut (BeStent 2) compared with a sirolimus-eluting stent among patients with coronary artery disease.
Patients Enrolled: 500
Mean Follow Up: 1 year
Mean Patient Age: Mean age 67 years
Symptomatic coronary artery disease and significant angiographic stenosis in native coronary vessels.
Acute MI, left main lesion, in-stent restenosis, contraindications to the antiplatelet drugs (clopidogrel and aspirin).
Angiographic restenosis, defined as stenosis diameter ≥50% at 6 months
Target vessel revascularization at 1 year
Following passage of the guidewire through the target lesion, patients were randomized to percutaneous coronary intervention (PCI) using either the thin-strut, bare metal stent BeStent 2 (n=250; strut thickness 0.076 mm) or the Cypher sirolimus-eluting stent (n=250). Patients underwent angiographic follow-up at 6 months.
Clopidogrel (600 mg loading dose 2-4 hours prior to PCI; 75 mg/day for at least 6 months), IV aspirin and heparin during the procedure, aspirin (100 mg indefinitely).
Baseline clinical and angiographic characteristics were similar between treatment groups, with 42% of patients with unstable angina, 31% with diabetes, and 31% having had a prior MI. Multivessel disease was present in 81% of patients. Post-procedure diameter stenosis was larger in the sirolimus-eluting stent group compared with the bare-metal group (6.2% vs 3.8%, p<0.001). Number of stents used was 1.1 in the sirolimus group and 1.3 in the bare metal grou (p=0.002).
At 6 month angiographic follow-up, the primary endpoint of angiographic restenosis was lower in the sirolimus-eluting stent group compared with the bare metal stent group (8.3% vs 25.5%, p<0.001). Likewise, diameter stenosis was also lower (12.0% vs 30.7%, p<0.001), as was late lumen loss (0.14 mm vs 0.94 mm, p<0.001). The reduction in restenosis was driven primarily by the subgroup of patients with vessel <2.8 mm (n=235) (7.0% vs 34.2%, p<0.001) with no difference in those with vessels ≥2.8 mm (n=174) (10.0% vs 13.1%, p=0.52).
At one year clinical follow-up, target vessel revascularization had occurred in 7.2% of the sirolimus-eluting stent group compared with 18.8% of the bare metal stent group (p<0.001). There was no difference in death (2.8% vs 2.0%, p=0.57) or death or MI (7.2% vs 4.8%, p=0.27) but the composite of death, MI or TVR was lower in the sirolimus group (13.6% vs 22.4%, p=0.01), driven by the reduction in TVR. There was one stent thrombosis in each group.
Among patients with symptomatic coronary artery disease, PCI using a sirolimus-eluting stent was associated with lower rates of angiographic restenosis compared with PCI using a thin-strut, bare metal stent at 6 month angiographic follow-up.
A major criticism of prior studies comparing bare metal stents with a drug-eluting stents is the use of a thick-strut stent for the bare metal stent control group, such as was used in the SIRIUS trial. Thick strut stents have been shown to have higher restenosis rates compared with thin strut stents. The present trial is the first large-scale randomized study to evaluate a thin-strut bare metal stent compared with a drug-eluting stent. Despite use of a more optimal, thin-strut bare metal stent, restenosis was less frequent with use of the sirolimus-eluting stent.
Pache J, et al. Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial. Eur Heart J 2005; 26(13):1262-1268.
Keywords: Coronary Restenosis, Metals, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus
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