title: Final shape of biovascular scaffolds and clinical outcome. Results from a multicenter all-comers study with intravascular imaging.
abstract: OBJECTIVE
  Radial strength of bioresorbable vascular scaffolds (BVS) implanted in coronary arteries is still under debate. Moreover, their final shape patterns, when implanted in an all-comer, unselected population, have not yet been completely correlated with clinical outcome and should be better investigated.
  
  
  RESULTS
  A multicenter collaborative analysis was performed on all consecutive patients with native coronary artery disease undergoing PCI with intravascular imaging-guided BVS implantation. The BVS was arbitrarily categorized as having a final "oval shape" through intravascular imaging, if maximal lumen diameter was longer than 150% of minimal lumen diameter at the target lesion. Primary study-endpoint was device-oriented major adverse events (DOCE) at mid-term follow-up. Sixty-seven consecutive patients were evaluated at 6 European centers. Mean patient age was 58±11years, and 12 patients (18%) had diabetes. Mean percent diameter stenosis was 79±12.5%. Average lesion length was 24.4±13.8mm and 66% of lesions were AHA/ACC type B2/C. Postdilation rate was 91% and all BVS resulted well apposed to the vessel wall. Procedural success was achieved in all patients and 10 (14.9%) had an "oval shape" at intravascular imaging. This occurrence was not associated with an increase in periprocedural myocardial infarction (p=0.37) or DOCE during hospitalization (p=0.65). Seven-month DOCE occurred in 3 patients (5.6%) of the oval shape group, they were target-vessel revascularization and did not differ significantly between patients with vs. without final "oval shape" (p=0.34). We did not register episodes of scaffold thromboses.
  
  
  CONCLUSIONS
  In an all-comer population with complex coronary lesions treated with BVS, a final oval shape after postdilation was not rare and not associated with immediate and medium term adverse events.
authors.affiliation: Interventional Cardiology, A.O. Fatebenefratelli, Milano, Italy. Electronic address: bcortese@gmail.com.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.affiliation: Interventional Cardiology, A.O.U.P. Paolo Giaccone, Palermo, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Piraino
authors.affiliation: Interventional Cardiology, A.O. Fatebenefratelli, Milano, Italy.
authors.forename: Roberto A
authors.initials: RA
authors.lastname: Latini
authors.affiliation: Interventional Cardiology, Cliniche Humanitas, Milano, Italy.
authors.forename: Dennis
authors.initials: D
authors.lastname: Zavalloni
authors.affiliation: Unit of Cardiology, A.O. Bolognini, Seriate, BG, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ielasi
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, NL, Nederland.
authors.forename: Piefrancesco
authors.initials: P
authors.lastname: Agostoni
authors.affiliation: Interventional Cardiology, Ospedale di Lodi, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Mazzarotto
authors.affiliation: Unit of Cardiology, A.O. Bolognini, Seriate, BG, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: Interventional Cardiology, A.O. Fatebenefratelli, Milano, Italy.
authors.forename: Romano
authors.initials: R
authors.lastname: Seregni
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D011474:Prosthesis Design; D054457:Tissue Scaffolds; D016896:Treatment Outcome