Acute and 6-month clinical and angiographic outcome after implantation of the ACS duet stent for single-vessel coronary artery disease: Final resultsof the European and US ACS Multi-Link Duet registry

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 Febru ary 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 pros pective observational study. All patients received ticlopidine 500 mg/day f or 1 month and aspirin greater than or equal to 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 quan titative coronary angiography was 3.0 +/- 0.53 mm and postprocedural minimu m luminal diameter was 2.79 +/- 0.43 mm (12% +/- 9.3% diameter stenosis). A t 30 days, 96.7% of patients were event-free and at 6 months 88.1 % remaine d 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 divers e group of international investigators. With late outcomes at least compara ble to the best published results, this stent platform provides safe and ef fective percutaneous treatment of obstructive coronary artery disease. (C) 2001 Wiley-Liss, Inc.