Abstract 19309: Feasibility and Angiographic Six-Month Follow-up of Fractional Flow Reserve - Guided Coronary Angioplasty Using Paclitaxel-Coated Balloons Without Stent Implantation (OCTOPUS II Study, NCT 02120859)
Introduction: Percutaneous coronary interventions (PCI) with drug-eluting balloons (DEB) might be a promising trade-off between balloon angioplasty (POBA) and drug-eluting stents, since DEB effectively inhibit neointimal proliferation and also limit duration of dual antiplatelet therapy.
Hypothesis: We investigated the safety and feasibility of fractional flow reserve (FFR) - guided use of the paclitaxel-eluting Sequent Please™ DEB without stenting for elective PCI of de novo lesions.
Methods: In 46 consecutive patients (54 lesions) with stable symptomatic coronary artery disease (CAD) a FFR-guided POBA was performed. In case of a sufficient POBA result with residual stenosis < 40%, FFR > 0.8 and no flow-limiting dissection, another dilatation of the target lesion was carried out using the DEB. Quantitative coronary angiography (QCA) was attempted before and after the index procedure and at 6-month follow-up (f/u), when the late lumen loss (LLL) and net luminal gain (NLG) were calculated.
Results: The DEB-only concept could be applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 41 patients (47 lesions) (Fig.1). At the stenotic site, the lumen showed a trend towards progressive increase at f/u without aneurysm formation or restenosis after DEB-only treatment (Fig. 2).
Conclusions: The concept of FFR-guided DEB-only PCI of de novo lesions in stable CAD appeared safe and feasible and allowed to stop clopidogrel after 4 weeks. The antiproliferative effects of paclitaxel induce persistent vessel remodeling leading to late luminal gain at 6-month f/u after DEB angioplasty without stent implantation.
Author Disclosures: T.C. Poerner: Research Grant; Modest; B Braun, Abbott Vascular. Speakers Bureau; Modest; St. Jude Medical, B Braun. S. Otto: None. C. Duderstadt: None. J. Guttiérrez-Chico: None. H.R. Figulla: None.
- © 2014 by American Heart Association, Inc.