Early Vascular Response of a Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction-The OCIMI Study.

Abstract

Background: Few studies have addressed the early healing pattern of ultrathin strut drug-eluting stents implanted specifically for the treatment of acute myocardial infarction.

Aims: This study employed optical coherence tomography (OCT) to assess neointimal coverage and vascular healing following implantation of ultrathin biodegradable polymer-coated sirolimus-eluting stents (SES) in patients with ST-segment elevation myocardial infarction (STEMI).

Methods: The OCIMI study was a prospective, single-center investigation of 23 STEMI patients treated with Supraflex Cruz SES (Sahajanand Medical Technologies Ltd., Surat, India) during primary PCI between September 2019 and June 2020. All patients underwent OCT imaging at 3-month follow-up, and images were analyzed at an independent core laboratory by analysts blinded to clinical and procedural data.

Results: At the 3-month follow-up, no clinical events were reported. The analyzed stent length was 28.4 ± 12.0 mm, with a stent diameter of 2.70 ± 0.46 mm and a reference lumen diameter of 2.46 ± 0.44 mm. OCT demonstrated nearly complete stent strut coverage (99.94%), with uncovered struts observed in 0.06 ± 0.16% of total struts per stent. Incomplete stent apposition was present in 0.14 ± 0.37% of struts. The mean neointimal hyperplasia (NIH) area and thickness were 0.81 ± 0.40 mm² and 110 ± 40 µm, respectively, with a mean NIH unevenness score of 1.74 ± 0.19.

Conclusion: Primary PCI performed with Supraflex Cruz SES demonstrated excellent early vascular healing at the 3-month OCT follow-up. The extremely low incidence of uncovered struts may have implications for abbreviated dual antiplatelet therapy in high-bleeding risk STEMI patients.