Problem Angina with single vessel disease
Format Randomised double-blinded multi-center controlled study
Treatment Paclitaxel-eluting (TAXUS) stent
Control Bare-metal stent
Population 1314 patients
Inclusion criteria Patients who were at least 18 years of age, had stable or unstable angina or provokable ischemia, and were undergoing percutaneous coronary intervention for a single, previously untreated lesion in a native coronary artery were considered for enrollment.
Exclusion criteria Clinical exclusion criteria included previous or planned use of intravascular brachytherapy in the target vessel or of any drug-eluting stent; myocardial infarction within 72 hours before enrollment; a left ventricular ejection fraction of less than 25 percent; hemorrhagic diatheses; contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainless steel.
Follow-up 9 months
Primary endpoint Nine-month incidence of ischemia-driven target-vessel revascularization
Secondary endpoint(s) Extent of stenosis of the target lesion at nine months.
Details .
Brief summary: Piclitaxel-eluting stents (1st generation DES) reduces clinical and angiographic restonosis versus bare-metal stenting
PAPER: A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.
Date 15 Jan 2004
Journal N Engl J Med. 2004 Jan 15;350(3):221-31.
Information Piclitaxel-eluting (1st generation) stent versus bare metal stent for angina patients with single lesions
-Reduced clinical and angiographic restenosis at 9 months