Cobalt-chromium KAname™ coRonary stEnt system in the treatment of patients with coronary artery disease (KARE study).

Abstract

OBJECTIVES:

To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions.

BACKGROUND:

Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance.

METHODS:

Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume.

RESULTS:

Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm(3) for total population. There were no definite and probable stent thromboses up to 12 months.

CONCLUSIONS:

Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation.

• Authors: Didier Carrie, Volker Schächinger, Gian Battista Danzi, Carlos Macaya, Uwe Zeymer, Biljana Putnikovic, Andres Iniguez, Raul Moreno, Zlatko Mehmedbegovic, Branko Beleslin, KARE INVESTIGATORS
• Journal: Journal of interventional cardiology (J Interv Cardiol) Vol. 27 Issue 5 Pg. 491-9 (Oct 2014) ISSN: 1540-8183 [Electronic] United States
• PMID: 25175153 (Publication Type: Clinical Trial, Journal Article)
• Copyright: © 2014, Wiley Periodicals, Inc.

Chemical References

• Chromium
• Cobalt

Topics

• Aged
• Angioplasty, Balloon, Coronary
• Chromium
• Cobalt
• Coronary Angiography
• Coronary Artery Disease (therapy)
• Coronary Restenosis (epidemiology)
• Female
• France (epidemiology)
• Humans
• Hyperplasia
• Male
• Middle Aged
• Neointima (pathology)
• Prospective Studies
• Stents