Stent Coverage and Neointimal Proliferation in Bare Metal Stents Postdilated With a Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stents
| Autor: | Johannes Gassdorf, Christian Jung, Hans Rainer Figulla, Sylvia Otto, Björn Goebel, Florian Janiak, Tudor C. Poerner, Kristina Nitsche, Bruno Scheller |
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| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Paclitaxel medicine.medical_treatment Coronary Artery Disease Coronary Angiography Prosthesis Design Balloon Coronary Restenosis Coated Materials Biocompatible Restenosis Optical coherence tomography Predictive Value of Tests Germany Neointima medicine Humans Single-Blind Method Everolimus Prospective Studies Angioplasty Balloon Coronary Aged Cell Proliferation Sirolimus medicine.diagnostic_test business.industry Percutaneous coronary intervention Stent Cardiovascular Agents Drug-Eluting Stents Middle Aged medicine.disease Coronary Vessels Stenosis Treatment Outcome Metals Angiography Female Stents Radiology Cardiology and Cardiovascular Medicine business Nuclear medicine Tomography Optical Coherence Vascular Access Devices medicine.drug |
| Zdroj: | Circulation: Cardiovascular Interventions. 7:760-767 |
| ISSN: | 1941-7632 1941-7640 |
| DOI: | 10.1161/circinterventions.113.001146 |
| Popis: | Background— In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. Methods and Results— A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P =0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P =0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm 3 proliferation volume/cm stent length; P =0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P =0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P =0.409) was found. Conclusions— Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01056744. |
| Databáze: | OpenAIRE |
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