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Publications

Journal Article Ahead of print

PubMed: 41285658 DOI: 10.1016/j.carrev.2025.11.001

A randomized prospective study investigating the relationship between post-PCI wall shear stress and 12-month neointimal healing: The SHEAR-STENT study.

Cardiovasc Revasc Med

Authors: David S Molony, Olivia Hung, Michel Corban, Bill Gogas, Adrien Lefieux, Imran Shah, Keyana Komilian, Alex Adams, Christine Sykalo, Sheriff Dodoo, Arnav Kumar, Sonali Kumar, Jimmy Azarnoosh, Marina Piccinelli, Michael C McDaniel, Spencer B King, Charles Maynard, Yiannis S Chatzizisis, Shao-Liang Chen, Eun-Seok Shin, Goran Stankovic, Dejan Milasinovic, Andrejs Erglis, Hiromasa Otake, Takashi Akasaka, Javier Escaned, Bon Kwon-Koo, Chang Wook-Nam, Ki-Bum Won, Yoshinobu Murasato, Won Yik Lee, Seung Hun Lee, Joo-Yong Hahn, Joo Myung Lee, Don P Giddens, Alessandro Veneziani, Habib Samady

Affiliations

  • Georgia Heart Institute, Northeast Georgia Health System, Gainesville, GA, USA.
  • Division of Cardiology, Emory University, Atlanta, GA, USA.
  • Department of Biomedical Engineering, Georgia Institute of Technology, GA, USA; Department of Mathematics and Computer Science, Emory University, Atlanta, GA, USA.
  • Department of Health Services, University of Washington, Seattle, USA.
  • Division of Cardiovascular Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, FL, USA.
  • Nanjing First Hospital, Nanjing Medical University, China.
  • Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
  • Department of Cardiology, University Clinical Center of Serbia, Belgrade, Serbia.
  • Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia.
  • Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
  • Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.
  • Department of Cardiology, Hospital Clínico San Carlos, Madrid, Spain.
  • Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
  • Department of Cardiology, Chung-Ang University Gwangmyeong Medical Center, Chung-Ang University College of Medicine, Gwangmyeong, Republic of Korea.
  • Department of Cardiology and Clinical Research Center, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
  • Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Republic of Korea.
  • Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  • Department of Biomedical Engineering, Georgia Institute of Technology, GA, USA.
  • Department of Mathematics and Computer Science, Emory University, Atlanta, GA, USA.
  • Division of Cardiology, Emory University, Atlanta, GA, USA.

Abstract

BACKGROUND

While disturbed wall shear stress (WSS) is associated with coronary plaque progression and vulnerability, its influence on stent neointimal healing is not well characterized. We designed a prospective, randomized trial to investigate the influence of WSS on neointimal healing in angulated arteries undergoing percutaneous coronary intervention (PCI).

METHODS

Eighty-six patients were randomized to Xience Xpedition® (X-EES) or Resolute® Integrity/Onyx (R-ZES) drug-eluting stents. Patients underwent serial OCT imaging post PCI and at 12-months. Angiography was combined with OCT to generate post-stent vessel reconstructions. WSS was calculated using computational fluid dynamics. Post-stent WSS was related to strut, frame and patient level neointimal thickness (NIT) at 12-months.

RESULTS

Sixty patients met inclusion criteria and had adequate OCT image quality for analysis. Mean age was 62.7 years, 78 % were men, and 37 % had diabetes. NIT at 12-months was 0.09 mm (0.05-0.15). There was no difference in frame level NIT (p = 0.08) or post-stent WSS (p = 0.75) between X-EES or R-ZES. Patient level analysis demonstrated correlation coefficients between WSS and NIT ranging from -0.78 to 0.67. Of these, 33 % were significantly positive, indicating an association between high WSS and increased NIT, while 31.6 % were significantly negative signifying an association between low WSS and increased NIT. Age, gender, hyperlipidemia, diabetes, renal insufficiency or prior MI was not associated with the distribution of correlation coefficients.

CONCLUSIONS

The SHEAR-STENT study demonstrated no significant differences in WSS or NIT at 12 months between R-ZES and X-EES. A wide range of patient level correlation coefficients between WSS and NIT were observed, with some patients showing increased NIT was associated with low WSS and others associated with high WSS.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT02098876.

MeSH

Diabetes Mellitus, Stents, Stress, Physiological, Prospective Studies