Why the study?
Does the ACS Multi-Link Duet coronary stent system provide safe and effective treatment for patients with single, symptomatic, de novo, native coronary artery lesions?
Does the ACS Multi-Link Duet coronary stent system provide safe and effective treatment for patients with single, symptomatic, de novo, native coronary artery lesions?
The ACS Multi-Link Duet stent demonstrated high procedural success and favorable 6-month clinical and angiographic outcomes for single-vessel coronary artery disease.
May support use in single-vessel lesions; leaves open need for randomized comparisons to modern stents.
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.
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Foley et al. (2001) studied this question.
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