One-Year Clinical Outcomes of Patients Presenting With ST-Segment Elevation Myocardial Infarction Caused by Bifurcation Culprit Lesions Treated With the Stentys Self-Apposing Coronary Stent: Results From the APPOSITION III Study

J Invasive Cardiol. 2017 Aug;29(8):253-258.

Abstract

Objective: To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions.

Background: The nitinol, self-expanding Stentys was initially developed as a dedicated bifurcation stent. The stent facilitates a provisional strategy by accommodating its diameter to both the proximal and distal reference diameters and offering an opportunity to "disconnect" the interconnectors, opening the stent toward the side branch.

Methods: The APPOSITION (a post-market registry to assess the Stentys self-expanding coronary stent in acute myocardial infarction) III study was a prospective, multicenter, international, observational study including STEMI patients undergoing primary percutaneous coronary intervention (PCI) with the Stentys SAS. Clinical endpoints were evaluated and stratified by bifurcation vs non-bifurcation culprit lesions.

Results: From 965 patients included, a total of 123 (13%) were documented as having a bifurcation lesion. Target-vessel revascularization (TVR) rates were higher in the bifurcation subgroup (16.4% vs 10.0%; P=.04). Although not statistically significant, other endpoints were numerically higher in the bifurcation subgroup: major adverse cardiac events (MACE; 12.7% vs 8.8%), myocardial infarction (MI; 3.4% vs 1.8%), and definite/probable stent thrombosis (ST; 5.8% vs 3.1%). However, when postdilation was performed, clinical endpoints were similar between bifurcation and non-bifurcation lesions: MACE (8.7% vs 8.4%), MI (1.2% vs 0.7%), and definite/probable ST (3.7% vs 2.4%).

Conclusions: The use of the Stentys SAS was safe and feasible for the treatment of bifurcation lesions in the setting of primary PCI for STEMI treatment with acceptable 1-year cardiovascular event rates, which improved when postdilation was performed.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Alloys / therapeutic use*
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / methods
  • Coronary Angiography / methods
  • Coronary Vessels* / diagnostic imaging
  • Coronary Vessels* / pathology
  • Coronary Vessels* / surgery
  • Female
  • Humans
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Postoperative Complications* / epidemiology
  • Postoperative Complications* / etiology
  • Product Surveillance, Postmarketing
  • ST Elevation Myocardial Infarction / diagnosis
  • ST Elevation Myocardial Infarction / surgery*
  • Self Expandable Metallic Stents* / adverse effects
  • Self Expandable Metallic Stents* / statistics & numerical data

Substances

  • Alloys
  • nitinol