title: Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials.
abstract: OBJECTIVE
  The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation.
  
  
  BACKGROUND
  The thicker strut of metallic stents potentially contributes to a higher incidence of SBO.
  
  
  METHODS
  We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1.
  
  
  RESULTS
  Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08).
  
  
  CONCLUSIONS
  Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Hector M
authors.initials: HM
authors.lastname: García-García
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.forename: Christos V
authors.initials: CV
authors.lastname: Bourantas
authors.forename: Marie-Angèle
authors.initials: MA
authors.lastname: Morel
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Li
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000000981:diagnostic imaging / Q000453:epidemiology*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000453:epidemiology; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D000068338:Everolimus; D020123:Sirolimus