Aims: Long lesions and complex vessel anatomy frequently require the use of overlapping stents to treat a lesion. The purpose of this study was to evaluate the long-term effects of overlapping the Axxess Biolimus A9™ eluting stent (BES) with two of the most commonly used, commercially available drug eluting stents. These stents were compared to BxVelocity bare metal (BMS) stents in a porcine coronary stent-injury model.
Objectives: Mechanical properties of drug eluting stents (DES) will be measured to provide comparable numerical data to assess deliverability, and thus clinical performance.
Background: A novel stent platform eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and effi cacy of a biolimus-eluting stent (with biodegradable polymer) with a sirolimus-eluting stent (with durable polymer).
Patients with multi-vessel disease, diabetes and bifurcation lesions are among some of the most difficult lesion subgroups to treat effectively with percutaneous coronary intervention. Historically, bifurcation lesion location has been shown to be a predictor for major adverse cardiac events1. More recent studies of PCI using drug eluting stents (DES) in bifurcation lesions show that while target lesion revascularisation (TLR) rates are reduced, these lesions continue to be difficult to classify, difficult to treat, and associated with elevated complication rates such as periprocedural non-Q-wave MI2, side branch occlusion, and stent thrombosis3. These problems are not likely to be solved by procedure modifications alone; stent design modifications will play a role as well.
Drug-eluting stent technology consisting of a bare metal stent, carrier coating, bioactive drug and delivery system, offers an almost infinite range of possible device configurations. A growing understanding of the mechanisms of restenosis allows for the design of synergistic functions within these components, thus providing a basis for new and improved products. The BioMatrix® stent (Biosensors Interventional Technologies Pte Ltd., Singapore) elutes the new sirolimus derivative Biolimus A9® from a biodegradable polylactic acid polymer. Biolimus A9 possesses enhanced anti-inflammatory and antiproliferative activity with an improved pharmacokinetic profile. Permanent polymer-carrier-based platforms may be associated with inflammation, late thrombosis and restenosis. The BioMatrix, with its asymmetric and abluminal coating, releases Biolimus A9 into the vessel wall while the polylactic acid polymer is resorbed by surrounding tissues. Clinical studies have demonstrated the BioMatrix to be well tolerated and effective, and it has now become the subject of an aggressive clinical program.
This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, ≤24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 ± 0.43 vs 0.74 ± 0.45 mm, p <0.001) and in the segment (0.14 ± 0.45 vs 0.40 ± 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.
Objectives: The STEALTH (STent Eluting A9 BioLimus Trial in Humans) trial was the first-in-man study to assess the safety and efficacy of the bioabsorbable-polymer-coated Biolimus A9™-eluting BioMATRIX™-Stent, as compared to a bare metal stent control (S-Stent™).
Abstract: The purpose of this study is to demonstrate safety and effectiveness of the S-Stent in de novo coronary lesions treated with conventional percutaneous coronary balloon angioplasty. Between January 2000 and June 2001, 120 patients were prospectively enrolled at four study centers. Patients were treated with coronary stenting in a total of 137 lesions. Procedural success was achieved in 100% of 137 attempted lesions. Clinical success was 99.8%. In-hospital mortality was 0.8%; myocardial infarction occurred in 0.8% and stent thrombosis in 0.8%. After stent implantation, the minimal lumen diameter increased from 0.92 ± 0.43 to 2.74 ± 0.36 mm (P < 0.0001) and the percent diameter stenosis decreased from 68.0 ± 16.2 to 4.5 ± 12.0 (P < 0.0001). At 6-month follow-up, the percent diameter stenosis was 33.5 ± 21.3 and the angiographic restenosis rate was 16.5%. Target lesion revascularization was required in 12 patients (10.1%). We conclude that the use of S-Stent for coronary intervention resulted in a high procedural success rate and low angiographic restenosis at 6 months after implantation. Catheter Cardiovasc Interv 2004;62:439–444. © 2004 Wiley-Liss, Inc.
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