Acute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry

EuroIntervention. 2018 Jan 20;13(13):1554-1560. doi: 10.4244/EIJ-D-17-00886.

Abstract

Aims: The aim of this registry was to monitor practice patterns and outcomes in patients treated with Absorb bioresorbable vascular scaffolds (BVS) during the early phase of usage in the UK.

Methods and results: A total of 1,005 patients with de novo coronary lesions were treated using careful implantation techniques at 24 centres. Follow-up at one year was obtained in 99%. An independent clinical events committee and angiographic core lab adjudicated all events. Patient age was 52 years and 46% presented with acute coronary syndromes. Lesion complexity was B2/C in 47.4%, with an average of 1.4±0.6 BVS implanted and a BVS length of 28±14.3 mm. A single BVS was implanted in 71.3%. High pressure post-dilatation was performed in 94.9%, with 50% using intravascular imaging. Device success was achieved in 98.7% and procedure success in 97.3% of patients. At one year, the device-oriented endpoint target lesion failure was 3.2%, and the patient-oriented endpoint major adverse cardiac events was 3.4%. Definite ST occurred in 1.4%. By multivariable analysis, scaffold size of 2.5 mm predicted ST at one year (OR 3.27, 95% CI: 1.28-8.37; p=0.014).

Conclusions: With careful patient selection and technique, TLF rates following BVS implantation in real-world practice are comparable with contemporary drug-eluting stents. ST rates remain high, with small vessel size identified as a contributory factor.

Trial registration: ClinicalTrials.gov NCT01977534.

Publication types

  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / mortality
  • Acute Coronary Syndrome / physiopathology
  • Acute Coronary Syndrome / surgery*
  • Adult
  • Clinical Decision-Making
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / surgery*
  • Coronary Thrombosis / epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Selection
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Practice Patterns, Physicians'
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Prosthesis Design
  • Registries
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • United Kingdom / epidemiology

Associated data

  • ClinicalTrials.gov/NCT01977534