One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials

EuroIntervention. 2016 Nov 20;12(10):1255-1262. doi: 10.4244/EIJV12I10A206.

Abstract

Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial.

Methods and results: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation.

Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Absorbable Implants
  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / methods
  • Cardiovascular Agents / administration & dosage
  • Cardiovascular Agents / therapeutic use*
  • Drug-Eluting Stents*
  • Everolimus / therapeutic use*
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Metals
  • Middle Aged
  • Myocardial Infarction / therapy*
  • Propensity Score
  • Prospective Studies
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Immunosuppressive Agents
  • Metals
  • Everolimus