DCB Angioplasty for Coronary Lesions: an OCT Analysis
Condition: Coronary Stenosis; Drug-coated Balloon
MeSH terms: Coronary Stenosis
Study type: Observational [Patient Registry]

Summary: 
      In this study, the investigators preformed OCT before and after DCB treatment, as well as at
      6 months of follow-up, to assess the tissue characterization. The aim of this study was to
      investigate the relationship between quantitative and qualitative OCT findings, angiographic
      and clinical outcomes after PCB for coronary lesions.
    

Detailed description: 
      The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary
      intervention (PCI); it allows a rapid local release of an anti-restenotic drug without the
      use of a durable polymer or metal scaffold. The DCB has been proven to be effective with
      paclitaxel in preclinical trials and in clinical practice for the treatment of coronary
      lesions such as in-stent restenosis (ISR), de novo and bifurcation lesions. Optical coherence
      tomography (OCT) is an intravascular imaging modality that has higher resolution than
      intravascular ultrasound. Excellent contrast among lumen, vessel, and stent in OCT images
      allows accurate measurement of lumen and lesion. However, only a few studies have
      investigated the effect of DCB on the intimal lumen in the acute phase and during the
      follow-up using optical coherence tomography (OCT). In this study, the investigators
      preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess
      the tissue characterization.

      Demographic, angiographic, and procedural data were collected. Participants were followed up
      with coronary angiography and OCT for at least 6-9 months, combined with OCT to analyze
      qualitative analysis of changes in plaque characterization, and late lumen loss. The
      participants were followed up for long-term clinical events (including cardiac death, target
      vessel myocardial infarction, and clinically driven target lesion revascularization).
    

Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time ≥ 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with de-novo or in-stent restenotic coronary lesions were treated with DCB
      
Keywords: Drug-coated balloon; Optical coherence tomography; De-novo coronary lesions; In-stent restenosis