A randomized comparison of a sirolimus eluting stent with a standard stent for coronary revascularization

Study Question:
To compare the performance of sirolimus releasing stents with that of standard uncoated stents in patients undergoing percutaenous coronary intervention.

Methods:
Patients with a single de-novo coronary artery stenosis were randomized to implantation of a Sirolimus-coated, 18 mm Bx Velocity stent (120 patients) or of a standard stainless steel uncoated Bx Velocity stent (118 patients). The sirolimus-coated stent was designed to release 80% of the drug within 30 days from implantation. Quantitative Coronary Angiography (QCA) was performed at baseline, immediately after stent implantation, and at 180±30 days follow-up. The primary angiographic endpoint was in-stent late luminal loss as determined by QCA. Secondary end-points included percent diameter stenosis at follow-up, minimal lumen diameter of the stented segment and of the edges (5 mm distal and proximal to the stented segment), and restenosis defined as >50% diameter stenosis. The primary clinical endpoint was a composite of major adverse cardiac events (MACE) including death, Q-Wave and non Q-wave myocardial infarction, coronary artery bypass grafting, and revascularization of the target lesion or of the target vessel at 30 days, 6 months and 12 months.

Results:
Baseline clinical, angiographic and procedural characteristics were similar between the 2 groups. At 180−days follow-up, in stent late luminal loss was –0.01±0.33mm in the sirolimus stent group and 0.8±0.53mm in the standard stent group (p<0.001). Distal edge late luminal loss (–0.09±0.30mm vs. 0.12±0.44mm; p<0.001), and proximal edge late luminal loss (0.05±0.39mm vs. 0.29±0.48mm; p<0.001) were also significantly lower in the sirolimus stent group when compared with the standard stent group. These changes in late lumen morphology were associated with restenosis rates of 0% and 26.6% respectively (p<0.001). At 1−year follow-up, the rate of major adverse cardiac events was 5.8% in the sirolimus stent group, and 28.8% in the standard stent group (p<0.001). The difference between the 2 groups was due exclusively to a higher repeat target vessel revascularization rate in the standard stent group. There were no subacute or late stent thrombosis.

Conclusions:
When compared with implantation of standard stents, implantation of sirolimus-eluting stents results in sustained suppression of restenosis and improved long-term clinical outcomes.

Perspective:
The results of this study are outstanding, and confirm the results of prior small registries that have shown a virtual elimination of neointimal proliferation and restenosis in the absence of late stent thrombosis. A new revolution in interventional cardiology appears ready to begin. MM

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