Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes

Yonsei Med J. 2020 Dec;61(12):1004-1012. doi: 10.3349/ymj.2020.61.12.1004.

Abstract

Purpose: Dissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions.

Materials and methods: A total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis).

Results: The cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group, p=0.886) or in TVF (6.8% in non-dissection and 8.4% in dissection group, p=0.799) at a median follow-up of 3.4 years. In a multivariate analysis, the presence of dissection and its severity were not associated with LLL or TVF. Almost dissections (93.9%) were completely healed, and there was no newly developed dissection at 6-month angiography.

Conclusion: The presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Keywords: Balloon angioplasty; coronary heart disease; dissection; outcome research.

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects*
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / therapeutic use*
  • Coronary Angiography / methods*
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / therapy*
  • Dissection
  • Drug-Eluting Stents
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Postoperative Complications
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Paclitaxel

Associated data

  • ClinicalTrials.gov/NCT04619277