Angiographic and clinical outcomes of patients treated with everolimus-eluting bioresorbable stents in routine clinical practice: Results of the ISAR-ABSORB registry

Catheter Cardiovasc Interv. 2016 Apr;87(5):822-9. doi: 10.1002/ccd.26346. Epub 2015 Dec 28.

Abstract

Objectives: We aimed to analyze angiographic and clinical results of patients undergoing BRS implantation in a real-world setting.

Background: Angiographic and clinical outcome data from patients undergoing implantation of drug-eluting bioresorbable stents (BRS) in routine clinical practice is scant.

Methods: Consecutive patients undergoing implantation of everolimus-eluting BRS at two high-volume centers in Munich, Germany were enrolled. Data were collected prospectively. All patients were scheduled for angiographic surveillance 6-8 months after stent implantation. Quantitative coronary angiographic analysis was performed in a core laboratory. Clinical follow-up was performed to 12 months and events were adjudicated by independent assessors.

Results: A total of 419 patients were studied. Mean age was 66.6 ± 10.9 years, 31.5% had diabetes mellitus, 76.1% had multivessel disease, and 39.0% presented with acute coronary syndrome; 49.0% of lesions were AHA/ACC type B2/C, 13.1% had treatment of bifurcation lesions. Mean reference vessel diameter was 2.89 ± 0.46 mm. At angiographic follow-up in-stent late loss was 0.26 ± 0.51 mm, in-segment diameter stenosis was 27.5 ± 16.1, and binary angiographic restenosis was 7.5%. At 12 months, the rate of death, myocardial infarction, or target lesion revascularization was 13.1%. Definite stent thrombosis occurred in 2.6%.

Conclusions: The use of everolimus-eluting BRS in routine clinical practice is associated with high antirestenotic efficacy in patients undergoing angiographic surveillance. Overall clinical outcomes at 12 months are satisfactory though stent thrombosis rates are not insignificant. Further study with longer term follow-up and larger numbers of treated patients is required before we can be sure of the role of these devices in clinical practice.

Keywords: bioabsorbable devices/polymers; coronary artery disease; percutaneous coronary intervention; quantitative coronary angiography.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Absorbable Implants*
  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / mortality
  • Acute Coronary Syndrome / therapy*
  • Aged
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coronary Angiography*
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / etiology
  • Coronary Restenosis / prevention & control
  • Coronary Thrombosis / diagnostic imaging
  • Coronary Thrombosis / etiology
  • Coronary Thrombosis / prevention & control
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / drug effects*
  • Drug-Eluting Stents*
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Female
  • Germany
  • Hospitals, High-Volume
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / diagnostic imaging
  • Myocardial Infarction / etiology
  • Myocardial Infarction / prevention & control
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Predictive Value of Tests
  • Prosthesis Design
  • Registries
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Everolimus