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

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 .