The aim of the study was to determine the safety and efficacy of the second-generation ACS Multi-Link Duet coronary
stent system for the treatment of single, symptomatic, de novo, native coronary artery lesions. Between February and June 1998, 427 patients (69.3% male, 51.5% class 3 or 4 angina, 20.1% diabetic, 43.6%
hyperlipidemia) were included at 38 centers in this prospective observational study. All patients received
ticlopidine 500 mg/day for 1 month and
aspirin > or =100 mg/day. The Duet
stent was available in 8, 18, and 28 mm length and 3.0, 3.5, and 4.0 mm diameter. After adequate predilatation,
stents were successfully implanted, at up to 16 atm, in 99.3% of patients. Mean vessel diameter by core laboratory quantitative coronary angiography was 3.0 +/- 0.53 mm and postprocedural minimum
luminal diameter was 2.79 +/- 0.43 mm (12% +/- 9.3% diameter
stenosis). At 30 days, 96.7% of patients were event-free and at 6 months 88.1% remained free of
major adverse cardiac events. The restenosis rate was 18.1%. The ACS Duet
stent was safely implanted in >99% of target lesions by a diverse group of international investigators. With late outcomes at least comparable to the best published results, this
stent platform provides safe and effective percutaneous treatment of obstructive
coronary artery disease. Cathet Cardiovasc Intervent 2001;54:25-33.