SMT’s Tetrilimus Ultrathin EES Evaluated at 3 and 6 Months in EverOCT Study

June 14, 2021—Sahajanand Medical Technologies Limited (SMT) announced publication of 3- and 6-month results from the EverOCT study of the company’s Tetrilimus everolimus-eluting stent (EES) by optical coherence tomography (OCT) analysis.

The study, which assessed the immediate results and healing pattern in two different time frames, was published online ahead of print by Upendra Kaul, MD, et al in Catheterization and Cardiovascular Interventions.

According to SMT, EverOCT was a prospective, multicenter, single-arm, investigator-initiated study performed at seven sites in India between January 2017 and September 2018. OCT evaluations were conducted on 57 patients who underwent Tetrilimus stent implantation. Follow-up OCT was scheduled at 3 months for the 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.

The EverOCT study aimed to evaluate healing response at strut-level and cross-section level of this new ultrathin EES (60 μm) with biodegradable polymer, by means of serial OCT analysis at 3 and 6 months after implantation. The study documents the OCT healing parameters of Tetrilimus ultrathin (60 μm) strut stents > 3 mm. Tetrilimus has the 60 μm strut thickness for its entire size matrix (2- to 4.5-mm diameter), noted SMT.

In the EverOCT study, 61 Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow-up) OCT data was available for 12 patients at 3 months and 30 patients at 6 months.

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 and 99.77% of struts per lesion were covered.

The comparative data showed that there was no significant difference in coverage of stents, eccentricity index, and NIH thickness over the struts as compared to ≤ 3-mm diameter stents. Tetrilimus portrays uniform expansion and concentric apposition over the vessel wall.

The EverOCT study concluded that the results demonstrated rapid early healing of ultrathin Tetrilimus with nearly complete endothelization within 3 months and at 6 months accompanied with low accumulation and uniform distribution of neointimal hyperplasia.

Dr. Kaul, MD, who serves as Principal Investigator of the study, commented in SMT’s press release, “EverOCT is a unique study showing very efficient early healing process, which is just right in thickness and complete coverage for the continued long-term efficacy. It gives high level of confidence to reduce the intensity of potent dual antiplatelet therapy in high bleeding risk patients which are seen frequently in clinical practice.” Dr. Kaul is Chairman and Dean of the Batra Heart Research Center in New Delhi, India.