Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans: the TIMELESS study

Coron Artery Dis. 2017 Mar;28(2):126-134. doi: 10.1097/MCA.0000000000000453.

Abstract

Aims: Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear.

Patients and methods: The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-D,L-lactide-co-glycolide polymer-eluting everolimus.

Results: A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up.

Conclusion: In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

Publication types

  • Multicenter Study

MeSH terms

  • Absorbable Implants*
  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / therapy*
  • Aged
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Chromium
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / therapy*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / therapy*
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / drug effects*
  • Drug Therapy, Combination
  • Drug-Eluting Stents*
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Female
  • Humans
  • Lactic Acid / chemistry*
  • Male
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platinum
  • Polyglycolic Acid / chemistry*
  • Polylactic Acid-Polyglycolic Acid Copolymer
  • Predictive Value of Tests
  • Prosthesis Design
  • Time Factors
  • Tomography, Optical Coherence*
  • Treatment Outcome
  • Wound Healing / drug effects*

Substances

  • Cardiovascular Agents
  • Platelet Aggregation Inhibitors
  • Chromium
  • Polylactic Acid-Polyglycolic Acid Copolymer
  • Polyglycolic Acid
  • Lactic Acid
  • Platinum
  • Everolimus