title: 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm.
abstract: OBJECTIVE
  We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm).
  
  
  BACKGROUND
  BVS are a novel approach to treating coronary lesions and are untested in small vessels.
  
  
  METHODS
  The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD ≥2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients.
  
  
  RESULTS
  At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 ± 0.18 mm vs. 0.21 ± 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 ± 6.0% vs. 19.8 ± 8.5%; p = 0.3643).
  
  
  CONCLUSIONS
  The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels.
authors: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Roberto
authors: R
authors: Diletti
authors: Yoshinobu
authors: Y
authors: Onuma
authors: Vasim
authors: V
authors: Farooq
authors: Josep
authors: J
authors: Gomez-Lara
authors: Salvatore
authors: S
authors: Brugaletta
authors: Robert Jan
authors: RJ
authors: van Geuns
authors: Evelyn
authors: E
authors: Regar
authors: Bernard
authors: B
authors: de Bruyne
authors: Dariusz
authors: D
authors: Dudek
authors: Leif
authors: L
authors: Thuesen
authors: Bernard
authors: B
authors: Chevalier
authors: Dougal
authors: D
authors: McClean
authors: Stephan
authors: S
authors: Windecker
authors: Robert
authors: R
authors: Whitbourn
authors: Pieter
authors: P
authors: Smits
authors: Jacques
authors: J
authors: Koolen
authors: Ian
authors: I
authors: Meredith
authors: Dong
authors: D
authors: Li
authors: Susan
authors: S
authors: Veldhof
authors: Richard
authors: R
authors: Rapoza
authors: Hector M
authors: HM
authors: Garcia-Garcia
authors: John A
authors: JA
authors: Ormiston
authors: Patrick W
authors: PW
authors: Serruys
mesh_terms: D020341:Absorbable Implants; D017023:Coronary Angiography; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology*; D054855:Drug-Eluting Stents; D019160:Endosonography; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000031:analogs & derivatives*; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D020123:Sirolimus