Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study

Eur Heart J. 2014 Mar;35(12):777-86. doi: 10.1093/eurheartj/eht546. Epub 2014 Jan 6.

Abstract

Aims: We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI).

Methods and results: The present investigation is a prospective, single-arm, single-centre study, reporting data after the BVS implantation in STEMI patients. Quantitative coronary angiography and optical coherence tomography (OCT) data were evaluated. Clinical outcomes are reported at the 30-day follow-up. The intent-to-treat population comprises a total of 49 patients. The procedural success was 97.9%. Pre-procedure TIMI-flow was 0 in 50.0% of the patients; after the BVS implantation, a TIMI-flow III was achieved in 91.7% of patients and the post-procedure percentage diameter stenosis was 14.7 ± 8.2%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 ± 1.92 mm(2), minimum lumen area 5.95 ± 1.61 mm(2), mean incomplete scaffold apposition area 0.118 ± 0.162 mm(2), mean intraluminal defect area 0.013 ± 0.017 mm(2), and mean percentage malapposed struts per patient 2.80 ± 3.90%. Scaffolds with >5% malapposed struts were 7. At the 30-day follow-up, target-lesion failure rate was 0%. Non-target-vessel revascularization and target-vessel myocardial infarction (MI) were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or scaffold thrombosis were observed.

Conclusion: In the present series, the BVS implantation in patients presenting with acute MI appeared feasible, with high rate of final TIMI-flow III and good scaffold apposition. Larger studies are currently needed to confirm these preliminary data.

Keywords: Bioresorbable vascular scaffolds; Optical coherence tomography; ST-segment elevation myocardial infarction.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants
  • Drug-Eluting Stents*
  • Everolimus
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / drug therapy*
  • Prospective Studies
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Time-to-Treatment
  • Tissue Scaffolds*
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Tubulin Modulators / administration & dosage*

Substances

  • Tubulin Modulators
  • Everolimus
  • Sirolimus