An optical coherence tomography study of two new generation stents with biodegradable polymer carrier, eluting paclitaxel vs. biolimus-A9

• Published in: International journal of cardiology Vol. 157; no. 3; pp. 341 - 346
• Main Authors: Davlouros, Periklis A, Mavronasiou, Eleni, Xanthopoulou, Ioanna, Karantalis, Vasileios, Tsigkas, Grigorios, Hahalis, George, Alexopoulos, Dimitrios
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 14-06-2012; Elsevier
• Subjects: Absorbable Implants; Aged; Biolimus-A9; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - drug therapy; Drug Carriers - administration & dosage; Drug-Eluting Stents; Female; General aspects. Genetic counseling; Humans; Malapposition; Male; Medical genetics; Medical sciences; Middle Aged; Neointimal coverage; OCT; Paclitaxel; Paclitaxel - administration & dosage; Polymers - administration & dosage; Prospective Studies; Radiography; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Tomography, Optical Coherence - methods; Treatment Outcome; OCT; Biolimus-A9; Malapposition; Paclitaxel; Neointimal coverage; Antineoplastic agent; Endoprosthesis; Optical coherence tomography; Biodegradability; Control release polymer; Instrumentation therapy; Absorbable; Coverage; Stent; Genetic disease; Generation; Genetic counseling; Carrier; Cardiology; Comparative study
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2010.12.072

Abstract Background Tissue coverage and strut apposition of drug eluting stents (DES), which can be assessed with optical coherence tomography (OCT), may be associated with late stent thrombosis (LST). Methods Prospective observational angiographic and OCT follow-up at 6 months post-implantation of a biolimus-A9 eluting stent (BES) vs. a paclitaxel eluting stent (PES), with biodegradable polymer carriers. The primary outcome was the percent difference of uncovered struts between BESs and PESs. Results A maximum likelihood model was used for analysis, to account for data clustering. Sixteen patients were treated with BES (28 lesions/4530 struts) and 16 with PES (23 lesions/4450 struts). Overall, BESs compared to PESs had more uncovered [0.41% vs. 0.21%, difference estimate (DE) 0.2 (95% CI, 0.06–0.34), p = 0.006], malapposed [0.18% vs. 0.04%, DE 0.14 (95% CI 0.05–0.23), p = 0.003], uncovered and malapposed [0.08% vs. 0.026%, DE 0.057 (95% CI 0.015–0.1), p = 0.01] and protruding struts [0.23% vs. 0.04%, DE 0.185 (95% CI 0.1–0.27), p < 0.001], and significantly lower neointimal thickness (59.3 ± 28.2 μm vs. 201.7 ± 97.5, p < 0.001). None of the BESs was totally covered with neointima, in contrast to 5 (21.7%) PESs ( p = 0.01). Thrombus was detected in 1 (3.6%) BES and 5 (21.7%) PESs ( p = 0.05); however, no patient experienced clinical stent thrombosis. Conclusion Between two stents with biodegradable polymer, OCT demonstrated that BESs had more uncovered and malapposed struts compared to PESs at 6 months. This difference might be partly attributed to the more potent antiproliferative properties of biolimus-A9; however, its impact on clinical outcome and on the risk of LST is yet to be determined.