Final shape of biovascular scaffolds and clinical outcome. Results from a multicenter all-comers study with intravascular imaging

Int J Cardiol. 2017 Feb 1:228:209-213. doi: 10.1016/j.ijcard.2016.11.113. Epub 2016 Nov 9.

Abstract

Aims: 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.

Methods and 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.

Publication types

  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention*
  • Prospective Studies
  • Prosthesis Design*
  • Tissue Scaffolds*
  • Treatment Outcome