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Original research article
Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans
  1. Boris Vesga1,2,
  2. Hector Hernandez1,2,
  3. Sergio Higuera1,2,
  4. Pawel Gasior3,4,
  5. Dario Echeveri5,
  6. Juan A Delgado6,
  7. Antonio Dager7,
  8. Camilo Arana7,
  9. Charles Simonton8,
  10. Akiko Maehara9,
  11. Julio Palmaz10 and
  12. Juan F Granada11
  1. 1 Universidad Industrial de Santander, Bucaramanga, Colombia
  2. 2 Instituto del Corazon de Bucaramanga, Bucaramanga, Colombia
  3. 3 CRF-Skirball Center for Innovation, Orangeburg, New York, USA
  4. 4 3rd Department of Cardiology, Medical University of Silesia, Katowice, Poland
  5. 5 Fundacion Cardioinfantil Instituto de Cardiologia, Bogota, Colombia
  6. 6 Instituto Corbic, Envigado, Colombia
  7. 7 Angiografia de Occidente, Cali, Colombia
  8. 8 Abbott Vascular, Santa Clara, California, USA
  9. 9 Cardiology, Cardiovascular Research Foundation/Columbia University Medical Center, New York, USA
  10. 10 Palmaz Scientific, Fremont, California, USA
  11. 11 Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York, USA
  1. Correspondence to Dr. Juan F Granada; jgranada{at}crf.org

Abstract

Objective To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation.

Background In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS).

Methods A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis.

Results At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75–95.52) compared with the MSG group (74.21%, 58.85–86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group.

Conclusions MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents.

Classifications BMS, OCT, clinical trials.

  • bare metal stent
  • optical coherence tomography
  • clincial trials
  • percutaneous coronary intervention

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors BV, HH, SH, DE, JAD, AD and CA implemented the trial, monitored data collection and revised the draft paper. PG and AM analysed the data and drafted and revised the draft paper. CS revised the draft paper. JP designed the trial and revised the draft paper. JFG designed the trial, monitored data collection for the whole trial and drafted and revised the paper.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The study was approved by the local hospitals and followed the governmental regulations of the government of Colombia, South America.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Data sharing statement There is no additional data for this paper.

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