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Coronary Drug-eluting Stents
Bionert Stent Angiographic Study
a report by
Eulogio García Fernandez, Didier Carrie, Amadeu Betriu, José Ramón Rumoroso, Antonio Serra and Martí Puigfel
Hospital General Universitario Gregorio Marañón, Madrid
Drug-eluting stents (DES) have demonstrated their efficacy in reducing reference diameter by visual estimation of 3–4.5mm and a length of up to
restenosis and repeated revascularisation.
1–4
Some concerns related to DES 15mm. Diabetic patients and those with coronary total occlusion were
safety (increased late stent thrombosis, difficulties with antiplatelet therapy excluded from the study. Hypersensitivity or allergies to aspirin, heparin or
compliance) and cost restrictions have encouraged interventional clopidogrel were criteria for exclusion. Also excluded were those with
cardiologists to be selective in the use of DES and bare-metal stents (BMS).
5–8
thrombocytopenia or leucopenia, patients with ST-segment elevation
The latest generation of BMS have been successful in the treatment of myocardial infarction (MI) diagnosed within 24 hours of the intervention and
anatomically favourable lesions with a low incidence of major adverse those with severe hepatic and renal disease. Angiographic exclusion criteria
cardiac events (MACEs) at short- and mid-term follow-up. Some included lesions located in the left main trunk, those located at the ostium
practitioners prefer using BMS when facing lesions with low risk of of the left anterior descending and circumflex arteries and those containing
restenosis or problems with antiplatelet therapy compliance. This selection thrombus or with severe calcification.
of a BMS is especially important in cases of scheduled or probable
extracardiac surgery, or when there is no history of clear antiplatelet therapy Stent Procedure
adherence; therefore, it is important to have an effective BMS to successfully Percutaneous procedures for stent implantation were performed using the
treat these cases. femoral or radial approaches, according to the protocols of each centre. The
choice of pre-dilatation or direct stenting technique was left to the
This study aims to evaluate the short- and mid-term results of the Oxygen operator’s discretion. Nevertheless, direct stenting was not recommended in
Ion Bombarded Stents (Bionert) stent in the treatment of lesions with low cases of calcified lesions, in lesions located distal to severe tortuosity or if the
to medium risk of restenosis located in native coronary arteries, and to vessel was nearly occluded (lesion severity >90%). When pre-dilatation was
compare these results with those obtained by the reference required, it was advocated to use a balloon shorter than the stent to be
cobalt–chromium alloy stents (Driver
®
, Guidant Corporation and Vision
®
, used. The minimal pressure recommended for stent deployment was 10
Medtronic) and other BMS. It is a prospective, observational, multicentre atmospheres. Post-deployment dilatation at high pressure was left to the
study that has included 298 patients treated with the Bionert stent in judgement of the operator, but was recommended in cases of stent
European and South American hospitals. underexpansion suggested by angiographic and/or intravascular ultrasound
findings. Available stent sizes for the patients included in the study were
Description of the Stent 2.75, 3, 3.5, 4 and 4.5mm in diameter and 9, 14 and 18mm in length.
The Bionert stent is a stainless steel stent, the surface of which has been Intravenous or intra-arterial sodium heparin at a dose of at least 5,000IU was
modified by oxygen ionic implantation. This technology makes the stent administered before the procedure. They were also treated with
extremely biocompatible because the oxygen ions immobilise the heavy acetylsalicylic acid (ASA) 100–325mg, which was continued for life. Before,
metal ions and prevent them from being released into the bloodstream. As during or immediately after the stent implantation, the patients were also
a consequence, the nickel, chromium and molybdenum ions are treated with at least 300mg of clopidogrel as a loading dose, followed by
encapsulated into the structure of the stainless steel and kept inside. During 75mg/day for at least one month.
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 Follow-up
therefore the stent does not lose its configuration, does not delaminate in Post-procedure cardiac enzymes and surface electrocardiogram were
expansion and does not crack while being crimped onto the balloon. This monitored at least once in the first 24 hours, and repeated if the patient had
prevents thrombus formation. The Bionert stent is a laser-cut tube with chest pain or any other symptom suggestive of myocardial ischaemia.
open-cell design, and is flexible with a big radial force and minimal recoil. Patients were discharged the day after the procedure if there were no
Methods
Eulogio García Fernandez is Director of the Department
of Interventional Cardiology at the Hospital General
Patient Selection Universitario Gregorio Marañón in Madrid. He was
Patients included in the study presented stable or unstable angina or silent
previously an Associate Professor of Medicine at the
Universidad Complutense de Madrid. Dr Garcia has made
ischaemia, and were scheduled for percutaneous coronary intervention of
over 600 scientific contributions, including articles
de novo or restenotic lesions after balloon angioplasty. All of the lesions
published in both national and international journals. He is
a member of numerous professional associations.
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
E:
ejgarcia@retemail.es
restenotic lesions after balloon angioplasty located in vessels with a
© TOUCH BRIEFINGS 2008 55
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