title: Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial.
abstract: BACKGROUND
  The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation.
  
  
  METHODS
  In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The pre-reference vessel diameter (RVD) was <2.5 mm (small-vessel group) in 41 patients (41 lesions) and ≥2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD.
  
  
  RESULTS
  At 2-year angiographic follow-up no differences in late lumen loss (0.29±0.16 mm vs 0.25±0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25±3.47 mm(2) vs 13.09±3.38 mm(2) p=0.0015), scaffold area (5.76±0.96 mm(2) vs 6.41±1.30 mm(2) p=0.0008) and lumen area (5.71±0.98 mm(2) vs 6.20±1.27 mm(2) p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed.
  
  
  CONCLUSIONS
  Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positive vessel remodelling were observed in small vessels.
authors.affiliation: Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.forename: Chrysafios
authors.initials: C
authors.lastname: Girasis
authors.forename: Christos
authors.initials: C
authors.lastname: Bourantas
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Jung Ho
authors.initials: JH
authors.lastname: Heo
authors.forename: Bill D
authors.initials: BD
authors.lastname: Gogas
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
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: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Whitbourn
authors.forename: Pieter
authors.initials: P
authors.lastname: Smits
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Li
authors.forename: Karine
authors.initials: K
authors.lastname: Miquel-Hebert
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D000368:Aged; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000601:surgery; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000601:surgery; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus