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

BACKGROUND: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. METHODS: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. RESULTS: At six months, the degree of neointimal proliferation, manifested as the mean (+/-SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01+/-0.33 mm) than in the standard-stent group (0.80+/-0.53 mm, P<0.001). None of the patients in the sirolimus-stent group, as compared with 26.6 percent of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). There were no episodes of stent thrombosis. During a follow-up period of up to one year, the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the standard-stent group (P<0.001). The difference was due entirely to a higher rate of revascularization of the target vessel in the standard-stent group. CONCLUSIONS: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.

Trial
Journal Ref. Morice MC, et al: N Engl J Med 2002, 346:1773-1780.
Intervention Drug - Sirolimus-eluting stent
Number of sites 19
Countries involved 19 including France, the Netherlands, Brazil, Mexico, Italy, Hungary
Sample size 238
Type of statistical analyses Intention-to-treat
Risk of bias Overall: Low Risk details
Participant characteristics Age: 60.7
Condition: Unstable angina in 50% of patients
Baseline severity: Requirement for PCA
Duration of trial Between August 2000 and January 2001
Primary outcome MACE - death Q-wave or non-Q-wave Myocardial infarction, coronary bypass grafting and revascularization of target lesion
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
7 120 34 118 -22.98 %
Primary Angiographic end point was in-stent luminal late loss. Primary clinical end-point was MACE at 1, 6 months and 12 months P<0.001 using Fisher's exact test
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
1 3 5 5 5 -1 2 1 5