研究目的
To evaluate if biodegradable polymer (BP) reduces the incidence of late-acquired stent malapposition (LASM) compared to permanent polymer (PP) after treatment with newer generation drug-eluting stents (DES).
研究成果
The use of BP-DES reduced the occurrence of LASM due to positive remodeling compared to second generation PP-DES.
研究不足
Neither the interventionist nor the patient was blinded to the implanted stent type. The study endpoint was a surrogate endpoint, which could neither be influenced by the interventionist nor by the patient.
1:Experimental Design and Method Selection:
A prospective, randomized, single-center study comparing second generation PP-DES with BP-DES in regard to the incidence of LASM using optical coherence tomography (OCT) after one year.
2:Sample Selection and Data Sources:
Fifty patients with 59 lesions were randomized (2:1) to elective treatment with second generation PP-DES or BP-DES.
3:List of Experimental Equipment and Materials:
Optical coherence tomography console (C7/OPTIS OCT console, Lightlab/Abbott Vascular Inc.), DES with second-generation permanent and biodegradable polymer coatings.
4:Experimental Procedures and Operational Workflow:
Patients underwent OCT directly after stent implantation and after 1 year to assess stent malapposition.
5:Data Analysis Methods:
Quantitative coronary analyses (QCA) were performed using the Quantcor QCA software package. OCT images were analyzed for malapposition and other parameters.
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