Problem Angina patients
Format Randomised double-blind multicentre RCT
Treatment Sirolimus-eluting stent
Control Bare-metal stent
Population 238 patients
Inclusion criteria Patients were eligible for the study if they were 18 to 85 years old, were not pregnant and were protected against pregnancy during the study, and had received a diagnosis of stable or unstable angina or silent ischemia. Additional eligibility criteria were the presence of a single primary target lesion in a native coronary artery that was 2.5 to 3.5 mm in diameter and that could be covered by an 18-mm stent; stenosis of 51 to 99 percent of the luminal diameter, as estimated visually; and a flow rate of grade 1 or higher according to the classification of the Thrombolysis in Myocardial Infarction (TIMI) trial.
Exclusion criteria Patients were not eligible for enrollment if they had an evolving myocardial infarction, stenosis of the left-main coronary artery, unprotected by a graft, that caused luminal narrowing of 50 percent or more, an ostial lesion, a calcified lesion that could not be completely dilated before stenting, an angiographically visible thrombus within the target lesion, a left ventricular ejection fraction of less than 30 percent, or an intolerance of aspirin, clopidogrel, ticlopidine, heparin, stainless steel, or contrast material.
Follow-up Patients were evaluated at 30 days and at 6 and 12 months
Primary endpoint Primary angiographic endpoint: in-stent luminal late loss, as determined by quantitative angiography
Primary clinical endpoint: composite of major cardiac events, including death, Q-wave or non–Q-wave myocardial infarction, coronary-artery bypass grafting, and revascularization of the target lesion or vessel 30 days, 6 months, and 12 months after the index procedure. A non–Q-wave myocardial infarction was defined by an increase in the creatine kinase level to more than twice the upper limit of the normal range, accompanied by an increased level of creatine kinase MB, in the absence of new Q waves on the surface electrocardiogram.
Secondary endpoint(s) -
Details .
Brief summary: Sirolimus (1st gen) drug-eluting stent versus bare-metal reduced target vessel revascularisation at 1 year
PAPER: A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.
Date 6 Jun 2002
Journal N Engl J Med. 2002 Jun 6;346(23):1773-80.
Information Sirolimus (1st generation) drug-eluting stent versus bare metal stent
-Reduced angiographic stenosis at 1 year
-Reduced MACE (due to reduced target vessel revascularisation)