Serial evaluation of vascular responses after implantation of everolimus‐eluting coronary stent by optical coherence tomography

• Published in: Catheterization and cardiovascular interventions Vol. 99; no. 2; pp. 381 - 390
• Main Authors: Kaul, Upendra, Abhyankar, Atul, Abhaichand, Rajpal, Bhagwat, Ajit, Sengottuvelu, Gunasekaran, Bahuleyan, Charantharayil, Arambam, Priyadarshini, Yumnam, Diana
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-02-2022
• Subjects: Biodegradability; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - etiology; Coronary Artery Disease - therapy; Coronary Vessels - diagnostic imaging; Coronary Vessels - pathology; Drug-Eluting Stents; drug‐eluting stent; everolimus; Everolimus - adverse effects; Humans; Hyperplasia; Implants; Lesions; Neointima - etiology; Neointima - pathology; optical coherence tomography; percutaneous coronary intervention; Percutaneous Coronary Intervention - adverse effects; Polymers; Prospective Studies; Sirolimus; Stents; Tomography; Tomography, Optical Coherence; Treatment Outcome; everolimus; percutaneous coronary intervention; drug-eluting stent; optical coherence tomography
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.29794

Aim
To evaluate healing response at strut‐level and cross‐section level after implanting an ultra‐thin strut, everolimus‐eluting stent with biodegradable polymer (Tetrilimus) using optical coherence tomography (OCT) at 3 and 6 months.
Methods
This was prospective, multi‐centre, single‐arm, and investigator‐initiated study performed at seven Indian sites between January, 2017 and September, 2018. OCT evaluations were performed in 57 patients who underwent Tetrilimus stent implantation. Follow‐up OCT was scheduled at 3 months for first 16 patients and at 6 months for 41 patients. Primary outcomes included degree of strut coverage, malapposition and thickness of neointimal hyperplasia (NIH) over covered struts.
Results
Sixty one Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow‐up) OCT data was available for 12 patients and 30 patients at 3 and 6 months, respectively. At 3 months, rapid early healing was indicated by 95.48% covered struts per lesion with very low (0.11 ± 0.06 mm) NIH. At 6 months, NIH accumulation was greater (0.21 ± 0.07 mm) as compared to 3 months. 99.77% of struts per lesion were covered at 6 months. There was a very symmetrical healing as shown by very low eccentricity index. There was no difference in vascular healing between stents with small to moderate size vessels (≤3.00 mm) and large size vessels (>3.00 mm).
Conclusion
Present study demonstrated nearly complete endothelization and low NIH accumulation at 3 and 6 months following implantation of ultra‐thin strut everolimus‐eluting biodegradable polymer‐coated Tetrilimus stent. Moreover, though being an ultra‐thin strut stent, there was no difference in vascular healing and eccentricity after implantation of the Tetrilimus stents with smaller and larger diameters.