Fate of post-procedural malapposition of everolimus-eluting polymeric bioresorbable scaffold and everolimus-eluting cobalt chromium metallic stent in human coronary arteries: sequential assessment with optical coherence tomography in ABSORB Japan trial

Eur Heart J Cardiovasc Imaging. 2018 Jan 1;19(1):59-66. doi: 10.1093/ehjci/jew329.

Abstract

Aims: The natural course of post-procedural incomplete strut apposition (ISA) after the implantation of bioresorbable scaffolds (BVS) remains unknown. The purpose of the present study was to evaluate the fate of post-procedural ISA after everolimus-eluting Absorb BVS in comparison with the second-generation everolimus-eluting cobalt chromium stent (CoCr-EES).

Methods and results: Fate of post-procedural ISA was evaluated by serial optical coherence tomography (OCT) in the ABSORB Japan randomized trial [OCT-1 subgroup: 110 paired lesions of post-procedure and 2-year follow-up (BVS 73 lesions vs. CoCr-EES 37 lesions)] with respect to ISA distance. Post-procedure ISA struts were categorized into either 'resolved' or 'persistent' by matched OCT imaging at 2-year follow-up. Post-procedure %malapposed strut and ISA area were smaller in BVS than in CoCr-EES (%malapposed strut: 4.8 ± 6.9% vs. 9.9 ± 9.8%, P = 0.002; ISA area 0.10 ± 0.18 mm2 vs. 0.23 ± 0.26 mm2, P = 0.003). At 2-year follow-up, the difference diminished, and majority of the ISA struts spontaneously resolved in both arms (%malapposed strut: 0.10 ± 0.46% vs. 0.24 ± 0.65%, P = 0.183). Receiver operating characteristic curve analysis (BVS 661 struts vs. CoCr-EES 807 struts) demonstrated that the best cut-off value of endoluminal ISA distance post-procedure for predicting persistent-ISA at 2-year follow-up was 396 µm for BVS (sensitivity 0.875; specificity 0.851) and 359 µm for CoCr-EES (sensitivity 0.778; specificity 0.881).

Conclusion: BVS as compared with CoCr-EES allows larger ISA distance at post-procedure, although we should make every effort to minimize post-procedure ISA. The reported cut-off value of OCT-estimated ISA distance at post-stenting for predicting persistent-ISA would be helpful to optimize PCI with BVS and CoCr-EES.

Keywords: bioresorbable scaffold; metallic stent; optical coherence tomography; randomized controlled trial; strut malapposition.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Absorbable Implants
  • Aged
  • Chromium
  • Cobalt
  • Coronary Angiography / methods
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / surgery*
  • Drug-Eluting Stents*
  • Everolimus / therapeutic use*
  • Female
  • Follow-Up Studies
  • Humans
  • Japan
  • Linear Models
  • Male
  • Metals*
  • Middle Aged
  • Normal Distribution
  • Percutaneous Coronary Intervention / adverse effects*
  • Percutaneous Coronary Intervention / methods
  • Postoperative Complications / diagnostic imaging
  • Prospective Studies
  • Prosthesis Design
  • Prosthesis Failure
  • ROC Curve
  • Risk Assessment
  • Single-Blind Method
  • Tomography, Optical Coherence / methods*

Substances

  • Metals
  • Chromium
  • Cobalt
  • Everolimus