Sirolimus-eluting BiOSS LIM dedicated bifurcation stent in the treatment of unprotected distal left main stenosis

Catheter Cardiovasc Interv. 2019 Sep 1;94(3):323-331. doi: 10.1002/ccd.28132. Epub 2019 Feb 17.

Abstract

Background: Proximal optimization technique (POT) has been proposed to adapt the conventional drug-eluting stent (DES) with the fractal anatomy of the bifurcation. However, only few DES are labeled for post-expansion beyond 5.0 mm. Furthermore, recrossing in the side branch (SB) through the main vessel (MV) stent cells may be challenging.

Objectives: To compare the sirolimus-eluting, balloon-expandable dedicated bifurcation stent BiOSS LIM DES versus the second generation DES in the treatment of distal unprotected left main coronary arteries (ULMCAs) lesions.

Methods: Forty-two consecutive patients with distal ULMCA lesions were treated with the BiOSS LIM (BiOSS LIM group) in our center. A matched-group of patients treated with second-generation DES was selected from our database (Control group). The primary endpoint was the procedural complication rate, including (a) SB occlusion, defined as intraprocedural TIMI flow grade <3 immediately after MV stenting; and/or (b) trouble in SB access, defined as the need of ≥2 guidewires or a failure to recross in the SB trough the MV stent cells. The need of POT in the two groups was also analyzed.

Results: The primary endpoint occurred in four (9.5%) patients in the BiOSS LIM group and in 13 (31%) in the Control group (p = 0.028; OR = 4.25; 95% confidence interval: 1.25-14.43). POT was performed more often in the Control group (71% vs. 35%; p = 0.004).

Conclusions: Compared to conventional DES, the BiOSS LIM stent (1) facilitates SB recrossing and (2) fits well with the fractal anatomy of the left main bifurcation.

Keywords: bifurcation lesion; coronary artery disease; left main; stent.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Case-Control Studies
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / physiopathology
  • Coronary Stenosis / therapy*
  • Databases, Factual
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Design
  • Sirolimus / administration & dosage*
  • Sirolimus / adverse effects
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Sirolimus