Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation

Int J Cardiol. 2016 Oct 15;221:23-31. doi: 10.1016/j.ijcard.2016.07.002. Epub 2016 Jul 4.

Abstract

Background: Stent expansion remains one of the most important predictors of restenosis and subacute thrombosis, even with the use of drug-eluting stents. This study was designed to clarify the impact of lesion preparation on final stent expansion.

Methods: Sixty-six consecutive patients were included in this trial, and ultimately 52 enrolled non-calcified de novo lesions were randomly assigned to undergo single predilation with either a semi-compliant scoring balloon or a semi-compliant conventional balloon. Lesions were treated with a single 2.5- to 3.0-mm cobalt-chromium everolimus-eluting stent under optical coherence tomography (OCT) guidance without post-stenting dilation. Stent expansion was defined as the ratio of OCT-measured minimum stent area to the predicted stent area.

Results: Stent expansion was significantly higher after predilation by a scoring balloon (68.0% vs. 62.1%, p=0.017) with similar stent lumen eccentricity (0.84 vs. 0.80, p=0.18). Intimal disruption was induced significantly more frequently (68.0% vs. 38.4%, p=0.035) and was more extensive in the scoring group (122° vs. 65°, p=0.038). Lesions with intimal disruption after predilation achieved significantly higher stent expansion than that without it (67.7% vs. 61.6%, p=0.023). One case in the conventional group required target lesion revascularization; however, any other adverse clinical events including death, myocardial infarction, and stent thrombosis were not observed up to 9months after PCI in both groups.

Conclusions: In this randomized study, pretreatment with a scoring balloon enhanced stent expansion partly through induction of intimal disruption.

Clinical trial registration: URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000014176.

Keywords: Intimal disruption; Optical coherence tomography; Scoring balloon; Stent expansion; Stent recoil.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon* / adverse effects
  • Angioplasty, Balloon* / methods
  • Coronary Angiography / methods
  • Coronary Artery Disease* / diagnosis
  • Coronary Artery Disease* / physiopathology
  • Coronary Artery Disease* / therapy
  • Coronary Restenosis* / etiology
  • Coronary Restenosis* / pathology
  • Coronary Restenosis* / physiopathology
  • Coronary Restenosis* / prevention & control
  • Drug-Eluting Stents / adverse effects*
  • Everolimus / pharmacology
  • Female
  • Humans
  • Immunosuppressive Agents / pharmacology
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Thrombosis* / diagnosis
  • Thrombosis* / etiology
  • Thrombosis* / prevention & control
  • Tomography, Optical Coherence / methods
  • Tunica Intima* / diagnostic imaging
  • Tunica Intima* / injuries
  • Tunica Intima* / pathology

Substances

  • Immunosuppressive Agents
  • Everolimus