title: Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography.
abstract: BACKGROUND
  Percutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please®balloon without stenting for elective PCI of de novo lesions.
  
  
  RESULTS
  In 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: -0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment.
  
  
  CONCLUSIONS
  FFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months. Clinical trial registration http://www.clinicaltrials.gov . Unique identifier: NCT02120859.
authors.affiliation: Division of Cardiology, 1st Department of Medicine, University Hospital of Jena, 07747, Jena, Germany.
authors.forename: Tudor C
authors.initials: TC
authors.lastname: Poerner
authors.affiliation: Division of Cardiology, 1st Department of Medicine, University Hospital of Jena, 07747, Jena, Germany.
authors.forename: Corinna
authors.initials: C
authors.lastname: Duderstadt
authors.affiliation: Division of Cardiology, 1st Department of Medicine, University Hospital of Jena, 07747, Jena, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Goebel
authors.affiliation: Division of Cardiology, 1st Department of Medicine, University Hospital of Jena, 07747, Jena, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kretzschmar
authors.affiliation: Division of Cardiology, 1st Department of Medicine, University Hospital of Jena, 07747, Jena, Germany.
authors.forename: Hans R
authors.initials: HR
authors.lastname: Figulla
authors.affiliation: Division of Cardiology, 1st Department of Medicine, University Hospital of Jena, 07747, Jena, Germany. sylvia.otto@med.uni-jena.de.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Otto
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D006328:Cardiac Catheterization; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000503:physiopathology; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D053805:Fractional Flow Reserve, Myocardial; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D066253:Vascular Remodeling
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: Drug-coated balloon; Drug-eluting balloon; Optical coherence tomography; PCI