title: Comparison of in vivo acute stent recoil between the bioresorbable everolimus-eluting coronary scaffolds (revision 1.0 and 1.1) and the metallic everolimus-eluting stent.
abstract: OBJECTIVE
  The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V® everolimus-eluting metal stent (EES, SPIRIT I and II).
  
  
  METHODS
  In the ABSORB cohort B trial, 101 patients with one or two de-novo lesions were enrolled at 10 sites. In ABSORB cohort A, 27 patients treated with a BVS 1.0 were analyzed and compared with EES. Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage.
  
  
  RESULTS
  Out of 101 patients enrolled in the ABSORB cohort B trial, 88 patients are available for complete analysis of acute recoil. Absolute recoil of BVS 1.1 (0.19 ± 0.18 mm) was numerically higher than metallic EES (vs. 0.13 ± 0.21 mm) and similar to BVS 1.0 (0.20 ± 0.21 mm) but the differences did not reach statistical significance (P = 0.40). The acute percent recoil demonstrated the same trend (EES: 4.3% ± 7.1%, BVS 1.0: 6.9% ± 7.0%, BVS 1.1: 6.7% ± 6.4%, P = 0.22). In the multivariate regression model, high balloon/artery ratio (>1.1) (OR 1.91 [1.34-2.71]) was the predictive for high absolute recoil (>0.27 mm) while (larger) preprocedural MLD was protective (OR 0.84 [0.72-0.99]). The stent/scaffold type was not a predictor of acute recoil.
  
  
  CONCLUSIONS
  The average in vivo acute scaffold recoil of the BVS 1.1 is slightly higher than the metallic EES. However, the scaffold/stent type was not predictive of high acute recoil, while implantation in undersized vessels or usage of oversized devices might confound the results.
authors.affiliation: Department of Interventional Cardiology, Thorax Center, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Josep
authors.initials: J
authors.lastname: Gomez
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Peter
authors.initials: P
authors.lastname: Smits
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: Hector
authors.initials: H
authors.lastname: Garcia-Garcia
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D001315:Australia; D001672:Biocompatible Materials; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D009520:New Zealand; D016017:Odds Ratio; D011312:Pressure; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013314:Stress, Mechanical; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D002317:Cardiovascular Agents; D008670:Metals; D000068338:Everolimus; D020123:Sirolimus