Angioscopic Comparison of Early- and Mid-Term Vascular Responses Following Treatment of ST-Elevation Acute Myocardial Infarction With Biodegradable vs. Durable Polymer Everolimus-Eluting Stents - A Prespecified Subanalysis of the MECHANISM AMI RCT

Circ J. 2023 Apr 25;87(5):619-628. doi: 10.1253/circj.CJ-22-0534. Epub 2022 Nov 23.

Abstract

Background: The vessel healing process after implantation of biodegradable polymer (BP) and durable polymer (DP) everolimus-eluting stent (EES) in ST-elevation myocardial infarction (STEMI) lesions remains unclear.Methods and Results: We conducted a multicenter prospective randomized controlled trial to compare early (2 weeks) and mid-term (12 months) vascular responses after implantation of BP-EES vs. DP-EES in STEMI patients. In this prespecified subanalysis, serial coronary angioscopy (CAS) analysis was performed in 15 stents in the BP-EES arm (n=10 patients) and 14 stents in the DP-EES arm (n=10 patients). At the 2-week follow-up, there was no significant difference in the estimated marginal means of the neointimal coverage grade (primary endpoint) between the 2 arms (mean [±SE] 0.00±0.00 in both arms; P>0.999). There were no significant differences between the BP-EES and DP-EES groups in the yellow color grade (1.046±0.106 vs. 0.844±0.114, respectively; P=0.201) or the presence of thrombus (77.8% vs. 88.8%, respectively; P=0.205). At 12 months, competent strut coverage, defined as yellow color grade ≤1, no thrombus, and a neointimal coverage grade ≥1 was achieved more frequently in the BP-EES than DP-EES arm (85.2% vs. 53.1%; adjusted odds ratio 2.11 [95% confidence interval 1.26-3.53]; P=0.023).

Conclusions: Neointimal coverage 2 weeks after implantation of BP-EES and DP-EES in STEMI lesions was comparable on CAS evaluation. However, at 1 year, BP-EES was independently associated with competent strut coverage.

Keywords: Biodegradable polymer-coated everolimus-eluting stents; Coronary angioscopy; Drug-eluting stent; Durable polymer-coated everolimus-eluting stent; ST-segment elevation myocardial infarction.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Absorbable Implants
  • Angioscopy
  • Coronary Artery Disease* / therapy
  • Drug-Eluting Stents*
  • Everolimus
  • Humans
  • Percutaneous Coronary Intervention*
  • Polymers
  • Prospective Studies
  • ST Elevation Myocardial Infarction* / diagnostic imaging
  • ST Elevation Myocardial Infarction* / therapy
  • Sirolimus
  • Treatment Outcome

Substances

  • Everolimus
  • Sirolimus
  • Polymers