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Serial intravascular ultrasound evaluation of the DESolve™ novolimus‐eluting bioresorbable coronary scaffold system
Author(s) -
Barreira Gentil,
Costa J. Ribamar,
Costa Ricardo,
Staico Rodolfo,
Chamie Daniel,
Slhessarenko Juliano R.,
Tanajura Luiz Fernando,
Abizaid Andrea,
Sousa Amanda,
Abizaid Alexandre
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27591
Subject(s) - medicine , intravascular ultrasound , lumen (anatomy) , bioresorbable scaffold , percutaneous coronary intervention , cardiology , clinical endpoint , scaffold , angioplasty , radiology , myocardial infarction , randomized controlled trial , biomedical engineering
Abstract Introduction Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus‐eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. Methods Single‐center, prospective, non‐randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. Results Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm 2 vs. 7.35 ± 1.53 mm 2 , P < 0.002; and 101.19 ± 20.9 mm 3 vs. 118.51 ± 26.6 mm 3 , P = 0.001). Late lumen loss was 0.22 ± 0.30 mm at 6 months and 0.33 ± 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow‐up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. Conclusions IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.