Impact of post-procedural minimal stent area on 2-year clinical outcomes in the SYNTAX II trial

Catheter Cardiovasc Interv. 2019 Mar 1;93(4):E225-E234. doi: 10.1002/ccd.28105. Epub 2019 Jan 31.

Abstract

Objectives: To investigate the impact of minimal stent area (MSA) evaluated by post-procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three-vessel disease (TVD).

Background: The impact of post-procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD.

Methods: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a state-of-the-art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post-procedural MSA and lesion-level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion-oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization.

Results: Eight hundred and nineteen lesions with post-procedural MSA available in 367 patients were included in the analysis. The post-procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm2 , intermediate tercile: 5.0-6.7 mm2 , and largest tercile: >6.7 mm2 ). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post-procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR.

Conclusions: In the SYNTAX II trial, larger post-procedural MSA was independently associated with the lower rate of TLR at 2 years.

Keywords: coronary artery disease; imaging, intravascular ultrasound; stent, drug eluting.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Europe
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Interventional