Bionert Stent Angiographic Study

Bionert Stent Angiographic Study

Betriu Amadeu, Carrie Didier, Fernandez Eulogio García, Puigfel Martí , Serra Antonio
Interventional Cardiology - Volume 3 - Issue I
Published: November 2008
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Drug-eluting stents (DES) have demonstrated their efficacy in reducing restenosis and repeated revascularisation.1–4 Some concerns related to DES safety (increased late stent thrombosis, difficulties with antiplatelet therapy compliance) and cost restrictions have encouraged interventional cardiologists to be selective in the use of DES and bare-metal stents (BMS).5–8 The latest generation of BMS have been successful in the treatment of anatomically favourable lesions with a low incidence of major adverse cardiac events (MACEs) at short- and mid-term follow-up. Some practitioners prefer using BMS when facing lesions with low risk of restenosis or problems with antiplatelet therapy compliance. This selection of a BMS is especially important in cases of scheduled or probable extracardiac surgery, or when there is no history of clear antiplatelet therapy adherence; therefore, it is important to have an effective BMS to successfully treat these cases.

This study aims to evaluate the short- and mid-term results of the Oxygen Ion Bombarded Stents (Bionert) stent in the treatment of lesions with low to medium risk of restenosis located in native coronary arteries, and to compare these results with those obtained by the reference cobalt–chromium alloy stents (Driver®, Guidant Corporation and Vision®, Medtronic) and other BMS. It is a prospective, observational, multicentre study that has included 298 patients treated with the Bionert stent in European and South American hospitals.

Description of the Stent
The Bionert stent is a stainless steel stent, the surface of which has been modified by oxygen ionic implantation. This technology makes the stent extremely biocompatible because the oxygen ions immobilise the heavy metal ions and prevent them from being released into the bloodstream. As a consequence, the nickel, chromium and molybdenum ions are encapsulated into the structure of the stainless steel and kept inside. During in vitro studies the release of these heavy metal ions decreased three-fold. The surface modification is not a coating but a deep implantation and therefore the stent does not lose its configuration, does not delaminate in expansion and does not crack while being crimped onto the balloon. This prevents thrombus formation. The Bionert stent is a laser-cut tube with open-cell design, and is flexible with a big radial force and minimal recoil.

Methods

Patient Selection
Patients included in the study presented stable or unstable angina or silent ischaemia, and were scheduled for percutaneous coronary intervention of de novo or restenotic lesions after balloon angioplasty. All of the lesions were treated with a Bionert stent. To be included as a candidate in the study the patient had to be over 18 years of age, with one or two de novo restenotic lesions after balloon angioplasty located in vessels with a reference diameter by visual estimation of 3–4.5mm and a length of up to 15mm. Diabetic patients and those with coronary total occlusion were excluded from the study. Hypersensitivity or allergies to aspirin, heparin or clopidogrel were criteria for exclusion. Also excluded were those with thrombocytopenia or leucopenia, patients with ST-segment elevation myocardial infarction (MI) diagnosed within 24 hours of the intervention and those with severe hepatic and renal disease. Angiographic exclusion criteria included lesions located in the left main trunk, those located at the ostium of the left anterior descending and circumflex arteries and those containing thrombus or with severe calcification.

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References:
  1. Sousa JE, et al., Sustained Suppression of Neointimal Proliferation by Sirolimus-Eluting Stents: One-Year Angiographic and Intravascular Ultrasound Follow-Up, Circulation, 2001; 104:2007.
  2. Stone GW, et al., A polymer based paclitaxel-eluting stent in patients with coronary artery disease, N Engl J Med, 2004; 350:221–31.
  3. Colombo A, Taxus II International Study: Cohort I Slow Release Formulation; Six-Month Results Intent to Treat Analysis. Taxus II International Study: Cohort II Moderate Release Formulation; Six-Month Results Intent to Treat Analysis, TCT Scientific Session, 2002.
  4. Moses JW, et al., Sirolimus eluting stents versus standard stents in patients with stenosis in a native coronary artery, N Engl J Med, 2003;349:1315–23.
  5. Farb A, et al., Oral everolimus inhibits in-stent neointimal growth, Circulation, 2002;106:2379–84.
  6. Clappers N, Verheugt FWA, Hotline sessions of the 28th European Congress of Cardiology/World Congress of Cardiology 2006, Eur Heart J, 2006;27:2896–9.
  7. Colombo A, Corbett SJ, Drug eluting stent thrombosis: increasingly recognized but too frequently overemphasized, J Am Coll Cardiol, 2006;48:203–5.
  8. Cutlip DE, Windecker S, Mehran R, et al., Academic Research Consortium, Clinical endpoints in coronary stent trials: a case for standardized definitions, Circulation, 2007;115:2344–51.
  9. Lemos PA, et al., Comparison of late luminal loss response pattern after sirolimus eluting stent implantation or conventional stenting, Circulation, 2004;110:3199–3205.
  10. Biondi-Zoccai GG, et al., A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50279 patints at risk for coronary artery disease, Eur Heart J, 2006;27:2667–74.
  11. Marzocchi A, et al., Long term safety and Efficacy of Drug Eluting Stents. Two year of the REAL Multicenter Registry, Circulation, 2007;115:3181–8.
  12. Sabate M, et al., Randomized comparison of sirolimus eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the Diabetes and Sirolimus Eluting Stent (DIABETES) trial, Circulation, 2005;112: 2175–83.

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