Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery

TLDR

Coronary lesions in these patients are complex, with high rates of diabetes, long lesions, and small vessels, and earlier studies indicate sirolimus‑eluting stents reduce restenosis in simpler lesions. The study aimed to compare sirolimus‑eluting stents with standard stents in a randomized, double‑blind trial of 1058 patients with newly diagnosed native coronary lesions. Patients were randomized to receive either a sirolimus‑eluting or standard stent and followed for 270 days, with target vessel failure—comprising cardiac death, myocardial infarction, and repeat revascularization—as the primary endpoint. Sirolimus‑eluting stents lowered target vessel failure from 21.0 % to 8.6 % (P < 0.001), mainly by reducing revascularization, also decreased neointimal hyperplasia, and showed consistent benefits across all subgroups.

Abstract

Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization.We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days.The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined.In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.